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OP RSH PRO00045934 R5458-HM-24145 GANGULY ARM B DARATUMUMAB	

Types:      Research Oncology Treatment
Synonyms:  PRO00045934 R5458-HM-24145, LINVOSELTAMAB

Cycle 1	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	EORTC IL478. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation..
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Date of Hepatitis B and C Panel: ***
Results of Hepatitis B and C Panel: ***
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	1.     The protocol states that steroids are required after at least the first 3 doses of daratumumab. If the participant does not experience a major systemic administration-related reaction after the first 3 doses of daratumumab, discontinuation of corticosteroid post-medication should be considered per investigator discretion. 
2.     ACTION NEEDED: Please ensure patients have a prescription to start methylprednisolone 20 mg (or equivalent) orally x 2 days starting 24 hours after the daratumumab dose is given on cycle 1 days 1 + 8 + 15
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
  	TYPE AND SCREEN	Interval: --	Occurrences: --	Comments:	Draw type and screen as baseline BEFORE Daratumumab
			Labs
  	CD 4/8 SUBSET	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Imaging
☑	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Whole body imaging (MRI, FDG PET/CT, low-dose CT).More frequent imaging (ie, every 6 months) is recommended if there is evidence of biochemical progression.
And at suspected PD
		☐	PET CT WHOLE BODY	Interval: --	Occurrences: --		☐	MRI WHOLE BODY	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 100 mg	Dose: 100 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to chemotherapy.		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to chemotherapy.			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. AS CLINICALLY INDICATED.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	1.     The protocol states that steroids are required after at least the first 3 doses of daratumumab. If the participant does not experience a major systemic administration-related reaction after the first 3 doses of daratumumab, discontinuation of corticosteroid post-medication should be considered per investigator discretion. 
2.     ACTION NEEDED: Please ensure patients have a prescription to start methylprednisolone 20 mg (or equivalent) orally x 2 days starting 24 hours after the daratumumab dose is given on cycle 1 days 1 + 8 + 15
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 100 mg	Dose: 100 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to chemotherapy.		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to chemotherapy.			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. AS CLINICALLY INDICATED.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	1.     The protocol states that steroids are required after at least the first 3 doses of daratumumab. If the participant does not experience a major systemic administration-related reaction after the first 3 doses of daratumumab, discontinuation of corticosteroid post-medication should be considered per investigator discretion. 
2.     ACTION NEEDED: Please ensure patients have a prescription to start methylprednisolone 20 mg (or equivalent) orally x 2 days starting 24 hours after the daratumumab dose is given on cycle 1 days 1 + 8 + 15
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 22	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. AS CLINICALLY INDICATED.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 2	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	EORTC IL478. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation..
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. AS CLINICALLY INDICATED.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. AS CLINICALLY INDICATED.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 22	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. AS CLINICALLY INDICATED.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 3	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	EORTC IL478. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation..
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. AS CLINICALLY INDICATED.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 4	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	EORTC IL478. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation..
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
  	CD 4/8 SUBSET	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. AS CLINICALLY INDICATED.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 5	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	EORTC IL478. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation..
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. AS CLINICALLY INDICATED.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 6	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	EORTC IL478. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation..
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. AS CLINICALLY INDICATED.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 7	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	EORTC IL478. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation..
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 8	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
  	CD 4/8 SUBSET	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 9	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 10	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 11	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	EORTC IL478. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation..
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	BM aspirate and/or biopsy. C12D1,C24D1 At the time of suspected CR and suspected PD (±1 month).UV.
BM aspirate is required for MRD assessment. The 12-, 24-, and 36-month procedures can be skipped if another aspirate/biopsy (eg, suspected CR) was performed within 3 months of time point. See Section 8.2.4. annually for participants with ongoing CR or every 2 years(±3 months) for all other participants until diagnosis of MM.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 12	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
  	CD 4/8 SUBSET	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	BM aspirate and/or biopsy. C12D1,C24D1 At the time of suspected CR and suspected PD (±1 month).UV.
BM aspirate is required for MRD assessment. The 12-, 24-, and 36-month procedures can be skipped if another aspirate/biopsy (eg, suspected CR) was performed within 3 months of time point. See Section 8.2.4. annually for participants with ongoing CR or every 2 years(±3 months) for all other participants until diagnosis of MM.
			Imaging
☑	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Whole body imaging (MRI, FDG PET/CT, low-dose CT).More frequent imaging (ie, every 6 months) is recommended if there is evidence of biochemical progression.
And at suspected PD
		☐	PET CT WHOLE BODY	Interval: --	Occurrences: --		☐	MRI WHOLE BODY	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 13	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 14	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	EORTC IL478. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation..
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 15	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 16	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 17	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 18	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	EORTC IL478. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation..
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 19	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 20	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 21	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 22	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	EORTC IL478. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation..
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 23	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	BM aspirate and/or biopsy. C12D1,C24D1 At the time of suspected CR and suspected PD (±1 month).UV.
BM aspirate is required for MRD assessment. The 12-, 24-, and 36-month procedures can be skipped if another aspirate/biopsy (eg, suspected CR) was performed within 3 months of time point. See Section 8.2.4. annually for participants with ongoing CR or every 2 years(±3 months) for all other participants until diagnosis of MM.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 24	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	BM aspirate and/or biopsy. C12D1,C24D1 At the time of suspected CR and suspected PD (±1 month).UV.
BM aspirate is required for MRD assessment. The 12-, 24-, and 36-month procedures can be skipped if another aspirate/biopsy (eg, suspected CR) was performed within 3 months of time point. See Section 8.2.4. annually for participants with ongoing CR or every 2 years(±3 months) for all other participants until diagnosis of MM.
			Imaging
☑	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Whole body imaging (MRI, FDG PET/CT, low-dose CT).More frequent imaging (ie, every 6 months) is recommended if there is evidence of biochemical progression.
And at suspected PD
		☐	PET CT WHOLE BODY	Interval: --	Occurrences: --		☐	MRI WHOLE BODY	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 25	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 26	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	EORTC IL478. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation..
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 27	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 28	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 29	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 30	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	EORTC IL478. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation..
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 31	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 32	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 33	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 34	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	EORTC IL478. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation..
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 35	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	BM aspirate and/or biopsy. C12D1,C24D1 At the time of suspected CR and suspected PD (±1 month).UV.
BM aspirate is required for MRD assessment. The 12-, 24-, and 36-month procedures can be skipped if another aspirate/biopsy (eg, suspected CR) was performed within 3 months of time point. See Section 8.2.4. annually for participants with ongoing CR or every 2 years(±3 months) for all other participants until diagnosis of MM.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 36	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	BM aspirate and/or biopsy. C12D1,C24D1 At the time of suspected CR and suspected PD (±1 month).UV.
BM aspirate is required for MRD assessment. The 12-, 24-, and 36-month procedures can be skipped if another aspirate/biopsy (eg, suspected CR) was performed within 3 months of time point. See Section 8.2.4. annually for participants with ongoing CR or every 2 years(±3 months) for all other participants until diagnosis of MM.
			Imaging
☑	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Whole body imaging (MRI, FDG PET/CT, low-dose CT).More frequent imaging (ie, every 6 months) is recommended if there is evidence of biochemical progression.
And at suspected PD
		☐	PET CT WHOLE BODY	Interval: --	Occurrences: --		☐	MRI WHOLE BODY	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 37	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 38	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	EORTC IL478. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation..
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 39	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	EORTC IL478. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation..
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral prophylaxis with acyclovir or equivalent (per institutional standards) is recommended for all participants throughout the study duration to prevent herpes simplex virus and varicella zoster virus reactivation. Please ensure the patient has a script.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 60 mg	Dose: 60 mg	Route: intravenous	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose				Instructions:	Administer 60 minutes prior to Daratumumab			Chemotherapy
  	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
End of Treatment (EOT)	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
					
PTFU: ( POST TREATMENT FOLLOW UP) : Q4W (post-EOT Up to 39 months from C1D1)	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. 
AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	EORTC IL478. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation..
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
					
EFU (EFFICACY follow up ) : Q12w	Repeat 1 time	Cycle length: 84 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
		  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	EORTC IL478. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation..
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. All PRO questionnaires should be administered and completed by the participant prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478 and EQ- 5D-5L and FACIT Item GP5. See Section 8.11 Questionnaires administered during the post-treatment period (post EOT up to 39 months from C1D1) should follow the same administration schedule as the on-treatment period (Table 2) for both arms, regardless of treatment discontinuation.
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
			Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay
					
LTFU (LONG TERM FOLLOW UP) : Q16W	Repeat 1 time	Cycle length: 112 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 71	Interval: --	Occurrences: --	Comments:	Survival status/subsequent MM therapy/second primary malignancy. Section 8.2.5.
					
UV : Unscheduled Visit	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Limited physical examination. A complete physical exam may be completed, if clinically indicated. See Section 8.3.1.
Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Adverse events. Continuous reporting, for EFU only related Aes. See Section 8.4.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Concomitant medication. Continuous reporting , for EFU only CM for related AEs. See Section 6.9.2.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Continuous reporting,for EFU only CP related to AEs .
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Refer to Section 8.3.2 for collection time points.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	AS CLINICALLY INDICATED. See Section 8.3.3.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Overall response assessment. All response categories including PD require 2 consecutive measurements of the applicable disease parameter(s) for confirmation (imaging and BM aspirate and/or biopsy do not need to be repeated). This can occur at a regularly scheduled visit or an unscheduled visit. Section 8.2.1
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Hospitalization (planned or unplanned admission). Hospitalization data and the associated triggering events (including general ward, ICU, and ER visits) for all hospitalizations up to 90 days post last dose, hospitalizations after that for related AEs, will be collected continuously.
		  	DAILY WEIGHTS	Interval: --	Occurrences: --	Comments:	As Clinically Indicated
		  	ONC NURSING COMMUNICATION 103	Interval: --	Occurrences: --	Comments:	Brief neurological examination and ICE score. Assessments should be completed predose. May be completed up to 3 days prior to C1D1. Section 8.3.1.2.
C1D1,  Unscheduled Visit. As clinically indicated
			Labs
  	CD 4/8 SUBSET	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Samples should be taken predose. May be collected up to 3 days prior to C1D1. May be collected within 24 hours of all other scheduled treatment visits. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	See Section 8.3.4 and Appendix 2 (Section 10.2).
			Labs
☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
		☐	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.For women of child-bearing potential. CBP participants only: a serum beta-hCG must be obtained during screening within 72 hours of first dose administration. After screening, subsequent tests may be performed on urine. See Section 8.3.5 and Appendix 2 (Section 10.2).
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	BM aspirate and/or biopsy. C12D1,C24D1 At the time of suspected CR and suspected PD (±1 month).UV.
BM aspirate is required for MRD assessment. The 12-, 24-, and 36-month procedures can be skipped if another aspirate/biopsy (eg, suspected CR) was performed within 3 months of time point. See Section 8.2.4. annually for participants with ongoing CR or every 2 years(±3 months) for all other participants until diagnosis of MM.
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Overall response assessment and efficacy labs are not required once progression is confirmed. See Section 4.1.1.
For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected >=VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	If collected during screening, within 14 days of C1D1, sample collection at C1D1 is not required.For participants without measurable disease in the urine at baseline (<200 mg/24 hr), UPEP is only required at suspected GREATER THAN OR EQUAL TO VGPR and at suspected PD. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	PROTEIN, TOTAL	Interval: --	Occurrences: --	Comments:	Total protein (serum).
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Serum FLC. Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	ONC NURSING COMMUNICATION 115	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). 
Local laboratory results may be used if entered into the EDC. See Section 8.2.1.
		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification(IgA, IgM, IgG for all participants; IgD or IgE only for participants with respective IgD/IgE involvement). Local laboratory results may be used if entered into the EDC.
See Section 8.2.1.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	DIRA (SERUM). Daratumumab Interference Reflex Assay