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OP RESEARCH PRO00036193 ARM C MMY3002 GANGULY	

Types:      Research Oncology Treatment
Synonyms:  NCT05455320 

Day -3	Repeat 1 time	Cycle length: 2 days	Day 1	Perform every 1 day x1		Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Standard HM order includes creatinine and cystatin.
					
Take Home Medications	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Provider Communication
☑	ONC PROVIDER COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	o Patients should receive PCP and Herpes Zoster prophylaxis. No specific recs for PCP prophylaxis. 
o For Zoster ppx: Start within 1 week of study treatment admin and continue for 3 months post treatment completion.  Acceptable agents include:  acyclovir (eg, 400 mg given orally 3 times a day or 800 mg given orally 2 times a day), famciclovir (eg, 125 mg given orally 2 times a day), or valacyclovir (eg, 500 mg given orally 2 times a day). 
0 To add these orders, right click to select Add Orders then scroll down suggested protocol orders on left side panel.
			Take-Home Medications
☐	acyclovir (ZOVIRAX) 400 MG tablet	Dose: 400 mg	Route: oral	3 times daily	Dispense: --	Refills: --	Start: S				☐	acyclovir (ZOVIRAX) 800 MG tablet	Dose: 800 mg	Route: oral	2 times daily	Dispense: --	Refills: --	Start: S				☐	famciclovir (FAMVIR) 125 mg tablet	Dose: 125 mg	Route: oral	2 times daily	Dispense: --	Refills: --	Start: S				☐	valACYclovir (Valtrex) 500 MG tablet	Dose: 500 mg	Route: oral	2 times daily	Dispense: --	Refills: --	Start: S							
Cycle 1	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Neurologic examination as Clinically Indicated.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	MySIm-Q, PROMIS PF 8c, EORTC-QLQ-C30, EQ-5D-5L, PGI-S. Continue to be collected even if subsequent antimyeloma therapy is begun. 
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Collection ceased upon start of subsequent antimyeloma therapy/
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Remind patient NOT to start taking Pomalidomide UNTIL cycle 2.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Suspected sARR Grade GREATER than or EQUAL to 2 : Collect additional PK/immunogenicity sample as soon as sARR is detected, if feasible
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with confirmed CR or sCR, additional samples will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. Time of PD
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Suspected CRS or sARR or neurotoxicity event Grade GREATER than or EQUAL to 2 : Collect as soon as CRS, sARR or neurotoxicity is detected .
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with confirmed CR or sCR, additional samples will be collected 18 and 24 months post C1D1 (±1 month)
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1 prior to C1D1 (to be performed within 72 hours before dosing)
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1 prior to C1D1 (to be performed within 72 hours before dosing)
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1 prior to C1D1 (to be performed within 72 hours before dosing)
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1 prior to C1D1 (to be performed within 72 hours before dosing)
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1 prior to C1D1 (to be performed within 72 hours before dosing)
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1 prior to C1D1 (to be performed within 72 hours before dosing)
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 2	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Neurologic examination as Clinically Indicated.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Suspected sARR or neurotoxicity Grade GREATER than or EQUAL to 2: Collect additional PK/immunogenicity sample as soon as sARR or neurotoxicity is detected, if feasible. 
Suspected CRS event Grade GREATER than or EQUAL to 2: Collect additional PK/immunogenicity sample as soon as CRS is detected and 24 and 48 hours thereafter, if feasible.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Talquetamab Must be administered GREATER than or EQUAL to 20 hours after daratumumab SC given on C1D1.
		  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 10 mcg/kg (Treatment Plan)	Dose: 10 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 4	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
			Nursing Orders
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	Talquetamab to be administered on Day 4. However, may be administered on Day 3 with sponsor approval OR on Day 5 or Day 6 per investigator discretion.
* Step-up Dose 2 MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see also criteria in Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 60 mcg/kg (Treatment Plan)	Dose: 60 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Collection ceased upon start of subsequent antimyeloma therapy/
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization) : To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	POTASSIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	CALCIUM LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Administered Talquetamab on Day 8. However, may be administered on Day 7 with sponsor approval OR on Day 9 or Day 10 per investigator discretion.
* Step-up Dose 3 MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see also criteria in Section 6.9.2.2
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 400 mcg/kg (Treatment Plan)	Dose: 400 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Collection ceased upon start of subsequent antimyeloma therapy/
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization) : To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Suspected sARR or neurotoxicity Grade GREATER than or EQUAL to 2: Collect additional PK/immunogenicity sample as soon as sARR or neurotoxicity is detected, if feasible. 
Suspected CRS event Grade GREATER than or EQUAL to 2: Collect additional PK/immunogenicity sample as soon as CRS is detected and 24 and 48 hours thereafter, if feasible.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1 prior to C1D1 (to be performed within 72 hours before dosing)
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1 prior to C1D1 (to be performed within 72 hours before dosing)
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1 prior to C1D1 (to be performed within 72 hours before dosing)
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1 prior to C1D1 (to be performed within 72 hours before dosing)
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1 prior to C1D1 (to be performed within 72 hours before dosing)
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1 prior to C1D1 (to be performed within 72 hours before dosing)
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 22	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Collection ceased upon start of subsequent antimyeloma therapy/
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization) : To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with confirmed CR or sCR, additional samples will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. Time of PD
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Suspected CRS or sARR or neurotoxicity event Grade GREATER than or EQUAL to 2 : Collect as soon as CRS, sARR or neurotoxicity is detected .
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with confirmed CR or sCR, additional samples will be collected 18 and 24 months post C1D1 (±1 month)
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	POTASSIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	CALCIUM LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 2	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Collection ceased upon start of subsequent antimyeloma therapy/
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Suspected sARR or neurotoxicity Grade GREATER than or EQUAL to 2: Collect additional PK/immunogenicity sample as soon as sARR or neurotoxicity is detected, if feasible. 
Suspected CRS event Grade GREATER than or EQUAL to 2: Collect additional PK/immunogenicity sample as soon as CRS is detected and 24 and 48 hours thereafter, if feasible.
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Medications
  	dexAMETHasone (DECADRON) tablet 40 mg	Dose: 40 mg	Route: oral	once for 1 dose	Start: S			Instructions:	o Dexamethasone or equivalent (see Appendix 13). Give approximately 1 to 3 hours (+/- 15min) prior to administrtation of Daratumumab SC. 
o For participantsLESS than 75 years of age with BMI LESS than 18.5 or GREATER than or EQUAL to 75 years of age, the weekly dose of dexamethasone is 20 mg.			Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 1 Hours	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 4 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Collection ceased upon start of subsequent antimyeloma therapy/
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization) : To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Medications
  	dexAMETHasone (DECADRON) tablet 40 mg	Dose: 40 mg	Route: oral	once for 1 dose	Start: S			Instructions:	o Dexamethasone or equivalent (see Appendix 13). Give approximately 1 to 3 hours (+/- 15min) prior to administrtation of Daratumumab SC. 
o For participantsLESS than 75 years of age with BMI LESS than 18.5 or GREATER than or EQUAL to 75 years of age, the weekly dose of dexamethasone is 20 mg.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 1 Hours	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Collection ceased upon start of subsequent antimyeloma therapy/
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization) : To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	ONLY as clinically indicated.
		  	GGT	Interval: --	Occurrences: --	Comments:	ONLY as clinically indicated.
		  	LDH	Interval: --	Occurrences: --	Comments:	ONLY as clinically indicated.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	ONLY as clinically indicated.
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	ONLY as clinically indicated.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Medications
  	dexAMETHasone (DECADRON) tablet 40 mg	Dose: 40 mg	Route: oral	once for 1 dose	Start: S			Instructions:	o Dexamethasone or equivalent (see Appendix 13). Give approximately 1 to 3 hours (+/- 15min) prior to administrtation of Daratumumab SC. 
o For participantsLESS than 75 years of age with BMI LESS than 18.5 or GREATER than or EQUAL to 75 years of age, the weekly dose of dexamethasone is 20 mg.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 1 Hours	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 4 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 22	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION 13	Interval: --	Occurrences: --	Comments:	o Dexamethasone or equivalent (see Appendix 13). 
o For participantsLESS than 75 years of age with BMI LESS than 18.5 or GREATER than or EQUAL to 75 years of age, the weekly dose of dexamethasone is 20 mg.
			Take-Home Medications
  	dexAMETHasone (DECADRON) 4 MG tablet	Dose: --	Route: --		Dispense: 40 tablet	Refills: 0	Start: S			Instructions:	Take 10 tablets (40mg) by mouth on Days 8 and 22 of Cycle 3 and 4.  Take in the morning with food.			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Collection ceased upon start of subsequent antimyeloma therapy/
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization) : To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Medications
  	dexAMETHasone (DECADRON) tablet 40 mg	Dose: 40 mg	Route: oral	once for 1 dose	Start: S			Instructions:	o Dexamethasone or equivalent (see Appendix 13). Give approximately 1 to 3 hours (+/- 15min) prior to administrtation of Daratumumab SC. 
o For participantsLESS than 75 years of age with BMI LESS than 18.5 or GREATER than or EQUAL to 75 years of age, the weekly dose of dexamethasone is 20 mg.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 1 Hours	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 3	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Collection ceased upon start of subsequent antimyeloma therapy/
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Suspected sARR or neurotoxicity Grade GREATER than or EQUAL to 2: Collect additional PK/immunogenicity sample as soon as sARR or neurotoxicity is detected, if feasible. 
Suspected CRS event Grade GREATER than or EQUAL to 2: Collect additional PK/immunogenicity sample as soon as CRS is detected and 24 and 48 hours thereafter, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Suspected sARR Grade GREATER than or EQUAL to 2 : Collect additional PK/immunogenicity sample as soon as sARR is detected, if feasible
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with confirmed CR or sCR, additional samples will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. Time of PD
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Suspected CRS or sARR or neurotoxicity event Grade GREATER than or EQUAL to 2 : Collect as soon as CRS, sARR or neurotoxicity is detected .
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with confirmed CR or sCR, additional samples will be collected 18 and 24 months post C1D1 (±1 month)
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Medications
  	dexAMETHasone (DECADRON) tablet 40 mg	Dose: 40 mg	Route: oral	once for 1 dose	Start: S			Instructions:	o Dexamethasone or equivalent (see Appendix 13). Give approximately 1 to 3 hours (+/- 15min) prior to administrtation of Daratumumab SC. 
o For participantsLESS than 75 years of age with BMI LESS than 18.5 or GREATER than or EQUAL to 75 years of age, the weekly dose of dexamethasone is 20 mg.			Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 1 Hours	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 4 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
			Nursing Orders
  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Confirm patient is taking Dexamethasone as prescribed. 
				Day 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Collection ceased upon start of subsequent antimyeloma therapy/
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization) : To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Medications
  	dexAMETHasone (DECADRON) tablet 40 mg	Dose: 40 mg	Route: oral	once for 1 dose	Start: S			Instructions:	o Dexamethasone or equivalent (see Appendix 13). Give approximately 1 to 3 hours (+/- 15min) prior to administrtation of Daratumumab SC. 
o For participantsLESS than 75 years of age with BMI LESS than 18.5 or GREATER than or EQUAL to 75 years of age, the weekly dose of dexamethasone is 20 mg.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 1 Hours	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 4 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 22	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
			Nursing Orders
  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Confirm patient is taking Dexamethasone as prescribed. 
					
Cycle 4	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	MySIm-Q, PROMIS PF 8c, EORTC-QLQ-C30, EQ-5D-5L, PGI-S. Continue to be collected even if subsequent antimyeloma therapy is begun. 
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Collection ceased upon start of subsequent antimyeloma therapy/
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Medications
  	dexAMETHasone (DECADRON) tablet 40 mg	Dose: 40 mg	Route: oral	once for 1 dose	Start: S			Instructions:	o Dexamethasone or equivalent (see Appendix 13). Give approximately 1 to 3 hours (+/- 15min) prior to administrtation of Daratumumab SC. 
o For participantsLESS than 75 years of age with BMI LESS than 18.5 or GREATER than or EQUAL to 75 years of age, the weekly dose of dexamethasone is 20 mg.			Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 1 Hours	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 4 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
			Nursing Orders
  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Confirm patient is taking Dexamethasone as prescribed. 
				Day 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Collection ceased upon start of subsequent antimyeloma therapy/
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization) : To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Medications
  	dexAMETHasone (DECADRON) tablet 40 mg	Dose: 40 mg	Route: oral	once for 1 dose	Start: S			Instructions:	o Dexamethasone or equivalent (see Appendix 13). Give approximately 1 to 3 hours (+/- 15min) prior to administrtation of Daratumumab SC. 
o For participantsLESS than 75 years of age with BMI LESS than 18.5 or GREATER than or EQUAL to 75 years of age, the weekly dose of dexamethasone is 20 mg.			Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 1 Hours	Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 4 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 22	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
			Nursing Orders
  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Confirm patient is taking Dexamethasone as prescribed. 
					
Cycle 5	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Collection ceased upon start of subsequent antimyeloma therapy/
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization) : To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 6	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Suspected sARR or neurotoxicity Grade GREATER than or EQUAL to 2: Collect additional PK/immunogenicity sample as soon as sARR or neurotoxicity is detected, if feasible. 
Suspected CRS event Grade GREATER than or EQUAL to 2: Collect additional PK/immunogenicity sample as soon as CRS is detected and 24 and 48 hours thereafter, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Suspected sARR Grade GREATER than or EQUAL to 2 : Collect additional PK/immunogenicity sample as soon as sARR is detected, if feasible
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with confirmed CR or sCR, additional samples will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. Time of PD
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Suspected CRS or sARR or neurotoxicity event Grade GREATER than or EQUAL to 2 : Collect as soon as CRS, sARR or neurotoxicity is detected .
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with confirmed CR or sCR, additional samples will be collected 18 and 24 months post C1D1 (±1 month)
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Collection ceased upon start of subsequent antimyeloma therapy/
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization) : To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 7	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	MySIm-Q, PROMIS PF 8c, EORTC-QLQ-C30, EQ-5D-5L, PGI-S. Continue to be collected even if subsequent antimyeloma therapy is begun. 
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 8	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 9	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 10	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	MySIm-Q, PROMIS PF 8c, EORTC-QLQ-C30, EQ-5D-5L, PGI-S. Continue to be collected even if subsequent antimyeloma therapy is begun. 
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 11	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 12	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Suspected sARR or neurotoxicity Grade GREATER than or EQUAL to 2: Collect additional PK/immunogenicity sample as soon as sARR or neurotoxicity is detected, if feasible. 
Suspected CRS event Grade GREATER than or EQUAL to 2: Collect additional PK/immunogenicity sample as soon as CRS is detected and 24 and 48 hours thereafter, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Suspected sARR Grade GREATER than or EQUAL to 2 : Collect additional PK/immunogenicity sample as soon as sARR is detected, if feasible
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with confirmed CR or sCR, additional samples will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. Time of PD
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with confirmed CR or sCR, additional samples will be collected 18 and 24 months post C1D1 (±1 month)
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 13	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	MySIm-Q, PROMIS PF 8c, EORTC-QLQ-C30, EQ-5D-5L, PGI-S. Continue to be collected even if subsequent antimyeloma therapy is begun. 
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 14	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 15	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 16	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	MySIm-Q, PROMIS PF 8c, EORTC-QLQ-C30, EQ-5D-5L, PGI-S. Continue to be collected even if subsequent antimyeloma therapy is begun. 
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 17	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 18	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Suspected sARR or neurotoxicity Grade GREATER than or EQUAL to 2: Collect additional PK/immunogenicity sample as soon as sARR or neurotoxicity is detected, if feasible. 
Suspected CRS event Grade GREATER than or EQUAL to 2: Collect additional PK/immunogenicity sample as soon as CRS is detected and 24 and 48 hours thereafter, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Suspected sARR Grade GREATER than or EQUAL to 2 : Collect additional PK/immunogenicity sample as soon as sARR is detected, if feasible
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with confirmed CR or sCR, additional samples will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. Time of PD
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with confirmed CR or sCR, additional samples will be collected 18 and 24 months post C1D1 (±1 month)
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 19	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	MySIm-Q, PROMIS PF 8c, EORTC-QLQ-C30, EQ-5D-5L, PGI-S. Continue to be collected even if subsequent antimyeloma therapy is begun. 
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycles 20,21	Repeat 2 times	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 22	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	MySIm-Q, PROMIS PF 8c, EORTC-QLQ-C30, EQ-5D-5L, PGI-S. Continue to be collected even if subsequent antimyeloma therapy is begun. 
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 23	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 24	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Suspected sARR or neurotoxicity Grade GREATER than or EQUAL to 2: Collect additional PK/immunogenicity sample as soon as sARR or neurotoxicity is detected, if feasible. 
Suspected CRS event Grade GREATER than or EQUAL to 2: Collect additional PK/immunogenicity sample as soon as CRS is detected and 24 and 48 hours thereafter, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Suspected sARR Grade GREATER than or EQUAL to 2 : Collect additional PK/immunogenicity sample as soon as sARR is detected, if feasible
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with confirmed CR or sCR, additional samples will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. Time of PD
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with confirmed CR or sCR, additional samples will be collected 18 and 24 months post C1D1 (±1 month)
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 25	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomase: order as clinically indicated. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. 
o For assessment by physical examination (if applicable), every 28 days (±7 days); from C1D1; 
o For assessment by radiology, every 12 weeks (±7 days) from C1D1; 
o As clinically indicated for other participants.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Bone Marrow aspirate. Order if necessary. * Time of suspected CR or sCR 
o For participants with confirmed CR or sCR, additional sample will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. If 1 of these time points occurs within 1 month of suspected CR or sCR, a repeat bone marrow will not be requested. 
*Time of PD
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Assessment of lytic bone lesions: As clinically indicated to document response or disease progression or start of SST.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical examination Symptom Directed, as Clinically Indicated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	12-lead ECG as clinically indicated. Order as needed.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test as clinically indicated-For participants with known or suspected COPD or asthma.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	MySIm-Q, PROMIS PF 8c, EORTC-QLQ-C30, EQ-5D-5L, PGI-S. Continue to be collected even if subsequent antimyeloma therapy is begun. 
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Symptomatic Progression Evaluation: From 30 days prior to 30 days after confirmed PD (progressive disease) ,or the start of SST(Subsequent antimyeloma therapy), whichever is earlier. Progression-associated symptoms and concomitant medications will be documented in eCRF.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation: On dosing days, vital signs should be collected as follows: 
o Daratumumab SC: perform before start of administration. 
o Talquetamab SC. 
 Step-up doses and first treatment dose: perform before start of administration and 0.5, 1, 2, and 3 hours after end of administration: 
o For all other administrations: perform before start of administration and as clinically indicated. 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	For cytokine release syndrome (CRS) or if otherwise indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 24 hours of D1 of each cycle
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab SC are to be administered on the same day, daratumumab SC should be administered first. The following intervals between daratumumab SC and talquetamab SC should be followed:  
1. On Cycle 1 Day 8 AND 15, there should be GREATER than or EQUAL to 3 hours between the administration of daratumumab SC and talquetamab SC. 
2. Thereafter, talquetamab SC should be administered GREATER than or EQUAL to 1 hour after daratumumab SC.
3. Talquetamab SC will not be administered during or within 2 hours after resolution of any sARR related to daratumumab SC.
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	On Cycle 1 Day 15 or on the subsequent dosing day following the specified AEs (see Section 6.2.1): 
a. 20 mg dexamethasone must be administered approx. 1-3 hours (±15 min) prior to daratumumab SC.
B. Diphenhydramine 25 mg (or equivalent) and acetaminophen 650 to 1000 mg must be administered again prior to talquetamab SC if >6 hours have elapsed since the prior administration of dexamethasone for daratumumab SC.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Additional pretreatment medications such as Montelukast, and H2 antagonists or antiemetics are optional and may be used at investigator discretion.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S					Respiratory Care
  	pentamidine (NEBUPENT) 300 mg in sterile water (PF) 6 mL inhalation solution	Dose: 300 mg	Route: nebulization	once for 1 dose	Start: S			Instructions:	Dissolve one vial (300 mg) pentamidine in 6 mL sterile water for injection. Place the entire reconstituted contents of the vial into the Respirgard II nebulizer reservoir for administration.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PENTAMIDINE 300 MG SOLUTION FOR INHALATION	Medications	300 mg	Main Ingredient	No	WATER FOR INJECTION, STERILE INJECTION SOLUTION	Base	6 mL	Yes	Yes			  	albuterol (PROVENTIL) nebulizer solution 2.5 mg	Dose: 2.5 mg	Route: nebulization	once for 1 dose	Start: S					Chemotherapy
  	INV-Daratumumab/rHuPH20 subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose	Start: S			Instructions:	Prepared syringe contains active daratumumab/rHuPH20 (1800 mg/15 mL). Administer subcutaneously WITHOUT filter over 3 - 5 minutes. Prepared syringe is stable for 4 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	i. When multiple talquetamab syringes are needed for a dose, these are to be given at least 2cm apart. 
ii. On days that daratumumb and talquetamab are coadministered, they must be given at least 10cm apart (typically a different quadrant of the abdomen).
iii. On days when daratumumab and talquetamab are both given, talquetamab must be given at least 3 hours after daratumumab.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	The first treatment dose of talquetamab SC must be administered GREATER than or EQUAL to 2days after Step-up Dose 3. * Treatment doses MUST be delayed until CRS and/or ICANS associated with prior dose have fully resolved (see Section 6.9.2.2).
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-3/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose			Offset: 3 Hours	Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections, and 10cm from daratumumab administration site. Stable for 20 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.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
EOT	Repeat 1 time	Cycle length: 112 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	MySIm-Q, PROMIS PF 8c, EORTC-QLQ-C30, EQ-5D-5L, PGI-S. Continue to be collected even if subsequent antimyeloma therapy is begun. 
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs including oxygen saturation 
o Monitor until normalized after CRS or sARR. 
o Any additional vital signs assessments supporting the start and end dates of an AE should be reported in the eCRF.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Suspected sARR or neurotoxicity Grade GREATER than or EQUAL to 2: Collect additional PK/immunogenicity sample as soon as sARR or neurotoxicity is detected, if feasible. 
Suspected CRS event Grade GREATER than or EQUAL to 2: Collect additional PK/immunogenicity sample as soon as CRS is detected and 24 and 48 hours thereafter, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Suspected sARR Grade GREATER than or EQUAL to 2 : Collect additional PK/immunogenicity sample as soon as sARR is detected, if feasible
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with confirmed CR or sCR, additional samples will be collected 6, 12, 18, 24, 30, 36, 48, 60, and 72 months post C1D1 (±1 month) until PD. Time of PD
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	GGT	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LDH	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Ensure all values meet criteria in Section 5.1
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --					
Follow Up	Repeat 1 time	Cycle length: 112 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	o MySIm-Q, PROMIS PF 8c, EORTC-QLQ-C30, EQ-5D-5L, PGI-S. 
o Continue to be collected even if subsequent antimyeloma therapy is begun. 
o Every 16 weeks.
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Subsequent antimyeloma therapy 
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	MRU (medical resource utilization): To be collected continuously from the start of study treatment until 30 days after last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuous until 30 days after last dose; Related AEs/SAEs will be reported until EOS.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy: Continuous until EOS.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy: Continuous until 30 days after last dose; concomitant therapy given for any related AEs/SAEs reported until EOS.
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Survival: every 16 weeks
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Suspected sARR or neurotoxicity Grade GREATER than or EQUAL to 2: Collect additional PK/immunogenicity sample as soon as sARR or neurotoxicity is detected, if feasible. 
Suspected CRS event Grade GREATER than or EQUAL to 2: Collect additional PK/immunogenicity sample as soon as CRS is detected and 24 and 48 hours thereafter, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Suspected sARR Grade GREATER than or EQUAL to 2 : Collect additional PK/immunogenicity sample as soon as sARR is detected, if feasible
			Provider Communication
  	ONC PROVIDER COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	HBV and HCV PCR every 12 weeks for up to 6 months after last dose of study treatment for participants with history of HBV and/or HCV infection. Order if appropriate.
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	o Until PD or start of SST. 
o In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		☐	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	For participants with: 
* Measurable disease only by light chain: Day 1 of each cycle and, if applicable, each pre-PD disease evaluation visit until PD or start of SST. 
•*Measurable disease by serum and/or urine M spike: at time of suspected CR or sCR.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Until 100 days after last dose.