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OP RESEARCH PRO00035654 NCT04071457 GANGULY ARM 2 STEP 2	

Types:      Research Oncology Treatment
Synonyms:  SWOG

Take Home Medication	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Provide Lenalidomide prescription as appropriate. Follow standard of care ordering procedures in compliance with REMS. 
Lenalidomide capsules should be taken whole, with water, once daily. If a dose is missed, and it has been less than 12 hours since the preceding dose, the patient should take lenalidomide as soon as the patient remembers. If it has been more than 12 hours, the patient should skip the missed dose. 
Lenalidomide will continue at the starting dose for 3 cycles. After 3 cycles, the dose may be increased to 15 mg (at the discretion of treating physician), providing ANC GREATER than or EQUAL to 1000/mm3 and all non-hematologic toxicities have resolved to LESS than or EQUAL to Grade 1.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Provide post med prescriptions for Lenalidomide as appropriate.
1. Aspirin 81 mg by mouth once daily. Please NOTE: aspirin is not necessary if the patient is already on a DOAC, Warfarin, or LMHW.
2 . Imodium Take 2 capsules (4 mg) by mouth at the first onset of diarrhea, followed by 1 capsule (2 mg) every 2-4 hours until resolution of diarrhea. (maximum 16 mg/day). 
3. Valacyclovir 500 mg by mouth twice daily. For CrCl <10 mL/min, dose reduce to 500 mg every 24 hours.
			Take-Home Medications
  	aspirin 81 mg chewable tablet	Dose: 81 mg	Route: oral	daily	Dispense: 30 tablet	Refills: 11	Start: S				  	loperamide (Imodium A-D) 2 mg capsule	Dose: --	Route: --		Dispense: 30 capsule	Refills: 11				Instructions:	Take 2 capsules (4 mg) by mouth at the first onset of diarrhea, followed by 1 capsule (2 mg) every 2-4 hours until resolution of diarrhea. (maximum 16 mg/day).		  	valACYclovir (Valtrex) 500 MG tablet	Dose: 500 mg	Route: oral	2 times daily	Dispense: 60 tablet	Refills: 11	Start: S							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test 14 days prior to registration and again within 24 hours prior to starting treatment on
Cycle 1, Day 1.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	Perform only HMH. Otherwise, perform at Quest or LabCorp.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp.
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --			Labs
  	TYPE AND SCREEN	Interval: --	Occurrences: --			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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						Days 8,15,22	Perform every 7 days x3			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Pregnancy testing is required for WOCBP and must be repeated weekly for the first 28 days, then every 28 days (or every 14 days for women with irregular menstrual periods), and again 28 days after the last dose of lenalidomide (or 14 and 28 days after for women with irregular periods). Pregnancy testing will also be performed for missed periods or irregular menstrual bleeding.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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						Days 8,15,22	Perform every 7 days x3			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	UPEP response assessment must be completed for patients with measurable UPEP disease at diagnosis per Section 10.2.c. For patients that did not have
measurable disease by UPEP at diagnosis, if CR is suspected confirm with urine per Section 10.2.d. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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						Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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						Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	UPEP response assessment must be completed for patients with measurable UPEP disease at diagnosis per Section 10.2.c. For patients that did not have
measurable disease by UPEP at diagnosis, if CR is suspected confirm with urine per Section 10.2.d. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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						Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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						Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	UPEP response assessment must be completed for patients with measurable UPEP disease at diagnosis per Section 10.2.c. For patients that did not have
measurable disease by UPEP at diagnosis, if CR is suspected confirm with urine per Section 10.2.d. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	UPEP response assessment must be completed for patients with measurable UPEP disease at diagnosis per Section 10.2.c. For patients that did not have
measurable disease by UPEP at diagnosis, if CR is suspected confirm with urine per Section 10.2.d. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	UPEP response assessment must be completed for patients with measurable UPEP disease at diagnosis per Section 10.2.c. For patients that did not have
measurable disease by UPEP at diagnosis, if CR is suspected confirm with urine per Section 10.2.d. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Provide Lenalidomide prescription as appropriate. Follow standard of care ordering procedures in compliance with REMS. 
Lenalidomide capsules should be taken whole, with water, once daily. If a dose is missed, and it has been less than 12 hours since the preceding dose, the patient should take lenalidomide as soon as the patient remembers. If it has been more than 12 hours, the patient should skip the missed dose. 
Lenalidomide will continue at the starting dose for 3 cycles. After 3 cycles, the dose may be increased to 15 mg (at the discretion of treating physician), providing ANC GREATER than or EQUAL to 1000/mm3 and all non-hematologic toxicities have resolved to LESS than or EQUAL to Grade 1.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Provide post med prescriptions for Lenalidomide as appropriate.
1. Aspirin 81 mg by mouth once daily. Please NOTE: aspirin is not necessary if the patient is already on a DOAC, Warfarin, or LMHW.
2 . Imodium Take 2 capsules (4 mg) by mouth at the first onset of diarrhea, followed by 1 capsule (2 mg) every 2-4 hours until resolution of diarrhea. (maximum 16 mg/day). 
3. Valacyclovir 500 mg by mouth twice daily. For CrCl <10 mL/min, dose reduce to 500 mg every 24 hours.
			Take-Home Medications
  	aspirin 81 mg chewable tablet	Dose: 81 mg	Route: oral	daily	Dispense: 30 tablet	Refills: 11	Start: S				  	loperamide (Imodium A-D) 2 mg capsule	Dose: --	Route: --		Dispense: 30 capsule	Refills: 11				Instructions:	Take 2 capsules (4 mg) by mouth at the first onset of diarrhea, followed by 1 capsule (2 mg) every 2-4 hours until resolution of diarrhea. (maximum 16 mg/day).		  	valACYclovir (Valtrex) 500 MG tablet	Dose: 500 mg	Route: oral	2 times daily	Dispense: 60 tablet	Refills: 11	Start: S					Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Labs
  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	.
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --			Procedures
  	BIOPSY BONE MARROW	Interval: --	Occurrences: --	Comments:	Or aspirate. Please schedule per unit protocols.
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Diagnostic BMA Slides for MRD by NGS (Required) 
Archival Diagnostic Bone Marrow Slides. 
Instruction: Submit 3-5 diagnostic bone marrow slides meeting the following requirements:
o Bone marrow aspirate smear or FFPE re-cuts from bone marrow aspirate clot
(bone marrow biopsy core specimens are not accepted)
o Unstained slides without cover slips preferred*
o Ensure slide is labeled with the SWOG Patient ID. 
o Ship in slide box labeled with SWOG Patient ID. 
o Ensure slides are packed to avoid breakage during shipping. 
o Ship overnight at ambient temperature, 10 AM PT delivery. 
* Slides that include cover slips require additional processing time and may result in delayed result reporting. Ship with fresh Bone Marrow Aspirate at 1st Randomization Specimen Labeling, Packaging, and Shipping.
Specimens must be labeled with the following information:
o Protocol number (S1803). 
o SWOG patient ID. 
o Specimen ID as generated by the SWOG Specimen Tracking System (note each specimen should have a unique specimen ID).
o Sites NCI code. 
o Date and time of specimen collection.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone Marrow Aspirate (from first draw).  
Required (collect prior to Registration Step 2). 
Instructions: Overnight shipping required Lab# 233. 
For Reg Step 2 time point: Ship with diagnostic bone marrow aspirate slides. 
Instructions: Collect 2ml anticoagulated bone marrow aspirate in EDTA (lavender top) tube from the first draw at the time points listed (Note: only bone marrow aspirate may be used for the assay; blood may not be submitted in place of marrow. 
Collection Timepoint: Prior to Registration Step 2 (post transplant). 
Specimen Labeling, Packaging, and Shipping. 
Specimens must be labeled with the following information:
o Protocol number (S1803). 
o SWOG patient ID. 
o Specimen ID as generated by the SWOG Specimen Tracking System (note each specimen should have a unique specimen ID). 
o Sites NCI code. 
o Date and time of specimen collection.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone Marrow Aspirate for Banking.
Bone Marrow Aspirate (from first draw) Overnight shipping required Lab# 201. Refer to: Please collect 10-20 mL bone marrow aspirate in sodium heparin (green top) tubes or (if dry tap) 60 mL peripheral blood heparin (green top) tubes
https://www.swog.org/memberresources/biospecimenresources
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	PROMIS-29 Profile v2.1. 
For the 24 month assessment using the PROMIS-29 Profile v2.1, the PROMIS-29 Profile v2.1 must be administered prior to the patient knowing their MRD status. 
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Intolerance of Uncertainty Scale - Short Form. 
For the 24 month assessment using the IUS,
the IUS will be administered after knowledge of MRD status; additionally, for MRD-negative patients, the IUS must be administered after the patient has been
notified of their randomization assignment.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	UPEP response assessment must be completed for patients with measurable UPEP disease at diagnosis per Section 10.2.c. For patients that did not have
measurable disease by UPEP at diagnosis, if CR is suspected confirm with urine per Section 10.2.d. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone Marrow Aspirate (from first draw).  
Required (collect prior to Registration Step 2). 
Instructions: Overnight shipping required Lab# 233. 
For Reg Step 2 time point: Ship with diagnostic bone marrow aspirate slides. 
Instructions: Collect 2ml anticoagulated bone marrow aspirate in EDTA (lavender top) tube from the first draw at the time points listed (Note: only bone marrow aspirate may be used for the assay; blood may not be submitted in place of marrow. 
Collection Timepoint: Prior to Registration Step 2 (post transplant). 
Specimen Labeling, Packaging, and Shipping. 
Specimens must be labeled with the following information:
o Protocol number (S1803). 
o SWOG patient ID. 
o Specimen ID as generated by the SWOG Specimen Tracking System (note each specimen should have a unique specimen ID). 
o Sites NCI code. 
o Date and time of specimen collection.
			Procedures
  	BIOPSY BONE MARROW	Interval: --	Occurrences: --	Comments:	Or aspirate, and also for banking. Please schedule per unit protocols.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Bone Marrow Aspirate for MRD by NGS (Required) 
Timepoints correspond with 12M, 24M, 36M, 48M. 
Bone Marrow Aspirate (from first draw). 
Required (collection Timepoints: 12M, 24M, 36M, 48M). 
Instructions: Overnight shipping required Lab# 233. 
For Reg Step 2 time point: Ship with diagnostic bone marrow aspirate slides. 
Instructions: Collect 2ml anticoagulated bone marrow aspirate in EDTA (lavender top) tube from the first draw at the time points listed (Note: only bone marrow aspirate may be used for the assay; blood may not be submitted in place of marrow. 
Collection Timepoint: Prior to Registration Step 2 (post transplant). 
Specimen Labeling, Packaging, and Shipping. 
Specimens must be labeled with the following information: 
o Protocol number (S1803). 
o SWOG patient ID. 
o Specimen ID as generated by the SWOG Specimen Tracking System (note each specimen should have a unique specimen ID). 
o Sites NCI code. 
o Date and time of specimen collection.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	UPEP response assessment must be completed for patients with measurable UPEP disease at diagnosis per Section 10.2.c. For patients that did not have
measurable disease by UPEP at diagnosis, if CR is suspected confirm with urine per Section 10.2.d. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	UPEP response assessment must be completed for patients with measurable UPEP disease at diagnosis per Section 10.2.c. For patients that did not have
measurable disease by UPEP at diagnosis, if CR is suspected confirm with urine per Section 10.2.d. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	UPEP response assessment must be completed for patients with measurable UPEP disease at diagnosis per Section 10.2.c. For patients that did not have
measurable disease by UPEP at diagnosis, if CR is suspected confirm with urine per Section 10.2.d. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	UPEP response assessment must be completed for patients with measurable UPEP disease at diagnosis per Section 10.2.c. For patients that did not have
measurable disease by UPEP at diagnosis, if CR is suspected confirm with urine per Section 10.2.d. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	UPEP response assessment must be completed for patients with measurable UPEP disease at diagnosis per Section 10.2.c. For patients that did not have
measurable disease by UPEP at diagnosis, if CR is suspected confirm with urine per Section 10.2.d. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Provide Lenalidomide prescription as appropriate. Follow standard of care ordering procedures in compliance with REMS. 
Lenalidomide capsules should be taken whole, with water, once daily. If a dose is missed, and it has been less than 12 hours since the preceding dose, the patient should take lenalidomide as soon as the patient remembers. If it has been more than 12 hours, the patient should skip the missed dose. 
Lenalidomide will continue at the starting dose for 3 cycles. After 3 cycles, the dose may be increased to 15 mg (at the discretion of treating physician), providing ANC GREATER than or EQUAL to 1000/mm3 and all non-hematologic toxicities have resolved to LESS than or EQUAL to Grade 1.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Provide post med prescriptions for Lenalidomide as appropriate.
1. Aspirin 81 mg by mouth once daily. Please NOTE: aspirin is not necessary if the patient is already on a DOAC, Warfarin, or LMHW.
2 . Imodium Take 2 capsules (4 mg) by mouth at the first onset of diarrhea, followed by 1 capsule (2 mg) every 2-4 hours until resolution of diarrhea. (maximum 16 mg/day). 
3. Valacyclovir 500 mg by mouth twice daily. For CrCl <10 mL/min, dose reduce to 500 mg every 24 hours.
			Take-Home Medications
  	aspirin 81 mg chewable tablet	Dose: 81 mg	Route: oral	daily	Dispense: 30 tablet	Refills: 11	Start: S				  	loperamide (Imodium A-D) 2 mg capsule	Dose: --	Route: --		Dispense: 30 capsule	Refills: 11				Instructions:	Take 2 capsules (4 mg) by mouth at the first onset of diarrhea, followed by 1 capsule (2 mg) every 2-4 hours until resolution of diarrhea. (maximum 16 mg/day).		  	valACYclovir (Valtrex) 500 MG tablet	Dose: 500 mg	Route: oral	2 times daily	Dispense: 60 tablet	Refills: 11	Start: S					Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Labs
  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	.
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --			Procedures
  	BIOPSY BONE MARROW	Interval: --	Occurrences: --	Comments:	Or aspirate. Please schedule per unit protocols.
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Diagnostic BMA Slides for MRD by NGS (Required) 
Archival Diagnostic Bone Marrow Slides. 
Instruction: Submit 3-5 diagnostic bone marrow slides meeting the following requirements:
o Bone marrow aspirate smear or FFPE re-cuts from bone marrow aspirate clot
(bone marrow biopsy core specimens are not accepted)
o Unstained slides without cover slips preferred*
o Ensure slide is labeled with the SWOG Patient ID. 
o Ship in slide box labeled with SWOG Patient ID. 
o Ensure slides are packed to avoid breakage during shipping. 
o Ship overnight at ambient temperature, 10 AM PT delivery. 
* Slides that include cover slips require additional processing time and may result in delayed result reporting. Ship with fresh Bone Marrow Aspirate at 1st Randomization Specimen Labeling, Packaging, and Shipping.
Specimens must be labeled with the following information:
o Protocol number (S1803). 
o SWOG patient ID. 
o Specimen ID as generated by the SWOG Specimen Tracking System (note each specimen should have a unique specimen ID).
o Sites NCI code. 
o Date and time of specimen collection.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone Marrow Aspirate (from first draw).  
Required (collect prior to Registration Step 2). 
Instructions: Overnight shipping required Lab# 233. 
For Reg Step 2 time point: Ship with diagnostic bone marrow aspirate slides. 
Instructions: Collect 2ml anticoagulated bone marrow aspirate in EDTA (lavender top) tube from the first draw at the time points listed (Note: only bone marrow aspirate may be used for the assay; blood may not be submitted in place of marrow. 
Collection Timepoint: Prior to Registration Step 2 (post transplant). 
Specimen Labeling, Packaging, and Shipping. 
Specimens must be labeled with the following information:
o Protocol number (S1803). 
o SWOG patient ID. 
o Specimen ID as generated by the SWOG Specimen Tracking System (note each specimen should have a unique specimen ID). 
o Sites NCI code. 
o Date and time of specimen collection.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone Marrow Aspirate for Banking.
Bone Marrow Aspirate (from first draw) Overnight shipping required Lab# 201. Refer to: Please collect 10-20 mL bone marrow aspirate in sodium heparin (green top) tubes or (if dry tap) 60 mL peripheral blood heparin (green top) tubes
https://www.swog.org/memberresources/biospecimenresources
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	UPEP response assessment must be completed for patients with measurable UPEP disease at diagnosis per Section 10.2.c. For patients that did not have
measurable disease by UPEP at diagnosis, if CR is suspected confirm with urine per Section 10.2.d. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
o Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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							
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 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Verify patient is taking Lenalidomide orally as prescribed
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	PROMIS-29 Profile v2.1. 
For the 24 month assessment using the PROMIS-29 Profile v2.1, the PROMIS-29 Profile v2.1 must be administered prior to the patient knowing their MRD status. 
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Intolerance of Uncertainty Scale - Short Form. 
For the 24 month assessment using the IUS,
the IUS will be administered after knowledge of MRD status; additionally, for MRD-negative patients, the IUS must be administered after the patient has been
notified of their randomization assignment.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	o Skeletal Survey, whole body CT, MRI, or PET. 
o To be done at progression. Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution
of any new therapy. The second assessment can be done at any time. As Clinically Indicated.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	Progression identified by SPEP, UPEP, and/or Serum FLC must be confirmed with a second disease assessment. This should be done prior to the institution of any new therapy. The second assessment can be done at any time.
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone Marrow Aspirate (from first draw).  
Required (collect prior to Registration Step 2). 
Instructions: Overnight shipping required Lab# 233. 
For Reg Step 2 time point: Ship with diagnostic bone marrow aspirate slides. 
Instructions: Collect 2ml anticoagulated bone marrow aspirate in EDTA (lavender top) tube from the first draw at the time points listed (Note: only bone marrow aspirate may be used for the assay; blood may not be submitted in place of marrow. 
Collection Timepoint: Prior to Registration Step 2 (post transplant). 
Specimen Labeling, Packaging, and Shipping. 
Specimens must be labeled with the following information:
o Protocol number (S1803). 
o SWOG patient ID. 
o Specimen ID as generated by the SWOG Specimen Tracking System (note each specimen should have a unique specimen ID). 
o Sites NCI code. 
o Date and time of specimen collection.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone Marrow Aspirate for Banking.
Bone Marrow Aspirate (from first draw) Overnight shipping required Lab# 201. Refer to: Please collect 10-20 mL bone marrow aspirate in sodium heparin (green top) tubes or (if dry tap) 60 mL peripheral blood heparin (green top) tubes
https://www.swog.org/memberresources/biospecimenresources
			Procedures
  	BIOPSY BONE MARROW	Interval: --	Occurrences: --	Comments:	Or aspirate, and also for banking. Please schedule per unit protocols.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Bone Marrow Aspirate for MRD by NGS (Required) 
Timepoints correspond with 12M, 24M, 36M, 48M. 
Bone Marrow Aspirate (from first draw). 
Required (collection Timepoints: 12M, 24M, 36M, 48M). 
Instructions: Overnight shipping required Lab# 233. 
For Reg Step 2 time point: Ship with diagnostic bone marrow aspirate slides. 
Instructions: Collect 2ml anticoagulated bone marrow aspirate in EDTA (lavender top) tube from the first draw at the time points listed (Note: only bone marrow aspirate may be used for the assay; blood may not be submitted in place of marrow. 
Collection Timepoint: Prior to Registration Step 2 (post transplant). 
Specimen Labeling, Packaging, and Shipping. 
Specimens must be labeled with the following information: 
o Protocol number (S1803). 
o SWOG patient ID. 
o Specimen ID as generated by the SWOG Specimen Tracking System (note each specimen should have a unique specimen ID). 
o Sites NCI code. 
o Date and time of specimen collection.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Contact PI for IV premeds if patient cannot tolerate PO.
			Pre-Medications
☐	dexAMETHasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 60 minutes prior to daratumumab/rHuPH20.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (S1803/Pro00035654/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 12 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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