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IP/OP RSH PRO00041409 GANGULY MAJESTEC-7 ARM B	

Types:      Research Oncology Treatment
Synonyms:  PRO00041409, GANGULY, 64007957MMY3005, MAJESTEC-7

Cycle 1	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:64007957MMY3005_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:64007957MMY3005_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: Until discontinued	Occurrences: --	Comments:	IP admission needed for teclistamab on days 2, 4, 8 and need to be monitored for 48 hours post dose given on day 8.
		  	ONC NURSING COMMUNICATION 47	Interval: Until discontinued	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Physical examination. Symptom directed. AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas.Imaging/physical exam
		  	ONC NURSING COMMUNICATION 73	Interval: Until discontinued	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas.For participants with a history of plasmacytoma:
·  For assessment by physical examination (if applicable) Q4W (±1 week) for the first 2 years from C1D1 and then Q8W (±1 week) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST
·  For assessment by radiology, Q12W (±2 weeks) for the first 2 years from C1D1 and then Q16W (±4 weeks) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST.
As clinically indicated for other participants
		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF. 
supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	RESEARCH -  PULSE OXIMETRY	Interval: Daily	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	ONC NURSING COMMUNICATION 36	Interval: Until discontinued	Occurrences: --	Comments:	EORTC-QLQC30, EQ-5D-5L. Continue to be collected even if SST is begun
		  	ONC NURSING COMMUNICATION 72	Interval: Until discontinued	Occurrences: --	Comments:	PRO-CTCAE. Through Cycle 6 unless stopped earlier at the start of SST
		  	ONC NURSING COMMUNICATION 52	Interval: Until discontinued	Occurrences: --	Comments:	MRU. Collected continuously from the start of study treatment until 30 days after the last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 54	Interval: Until discontinued	Occurrences: --	Comments:	TTSP.At time of confirmed PD, document progression-associated symptoms and concomitant medications
		  	ONC NURSING COMMUNICATION 67	Interval: Until discontinued	Occurrences: --	Comments:	Adverse Events.Continuous until 30 days after last dose or until the start of SST, if earlier; thereafter, continue to report any AEs/SAEs related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 68	Interval: Until discontinued	Occurrences: --	Comments:	Second primary malignancy. Continuous from the time Second primary malignancy of signing of ICF
		  	ONC NURSING COMMUNICATION 69	Interval: Until discontinued	Occurrences: --	Comments:	Continuous until 30 days after last dose; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 72	Interval: Until discontinued	Occurrences: --	Comments:	Study visit.If the visit occurs later than planned, adjust subsequent visit(s) accordingly or skip dose per protocol
		  	ONC NURSING COMMUNICATION 8	Interval: Until discontinued	Occurrences: --	Comments:	When daratumumab SC and talquetamab are to be administered on the same day, daratumumab SC should be administered first.
The following intervals between daratumumab SC and talquetamab should be followed:
-         On Cycle 1 Day 8, talquetamab should be administered >=3 hours after daratumumab SC.
-         Note the requirements for repetition of the required pretreatment medications if >4 hours (steroid) or >6 hours (antihistamine, antipyretic) have elapsed since prior administration of the pretreatment medication (see Table 14)
-         Thereafter, talquetamab should be administered at least 15 minutes after daratumumab SC
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: Until discontinued	Occurrences: --	Comments:	Talquetamab (PK and ADA).Predose on the day of dosing. C1D1, C1D15, C4D1, C7D1, C10D1, C13D1, C25D1, EOT, Follow up (8 weeks after last dose).C1D1, C1D15, C4D1, C7D1, C10D1, C13D1, C25D1, EOT, Follow up (8 weeks after last dose). To be collected before administration of daratumumab SC
		  	ONC NURSING COMMUNICATION 75	Interval: Until discontinued	Occurrences: --	Comments:	Talquetamab (PK and ADA).Suspected Grade GREATER than or EQUAL to 3 sARR. Collect additional PK/immunogenicity sample as soon as Grade >=3 teclistamab- or talquetamab-related sARR is detected, if feasible
		  	ONC NURSING COMMUNICATION 6	Interval: Until discontinued	Occurrences: --	Comments:	Talquetamab (PK and ADA)
	
	Suspected GREATER than or EQUAL to 3 CRS or Grade GREATER than or EQUAL to 3 neurotoxicity/ICANS.
Collect additional PK/immunogenicity sample as soon as GREATER than or EQUAL to 3 CRS or Grade LESS than or EQUAL to 3 teclistamab- or talquetamab-related neurotoxicity/ICANS is detected, if feasible.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --	Comments:	CBC with differential.
Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	GGT	Interval: Once	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	LDH	Interval: Once	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	PHOSPHORUS LEVEL	Interval: STAT	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	AMYLASE LEVEL	Interval: Once	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.Lipase OR Amylase
		  	LIPASE LEVEL	Interval: Once	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.Lipase OR Amylase
		  	HEMOGLOBIN A1C	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --	Comments:	TLS-related.
Perform <=72 hours before dosing
		  	THYROID STIMULATING HORMONE	Interval: Once	Occurrences: --	Comments:	AS CLINICALLY INDICATED
		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --	Comments:	Perform only on participants who are treated with statins
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: Once	Occurrences: --	Comments:	Including at CRS onset if applicable
		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --	Comments:	Including at CRS onset if applicable
		  	FIBRINOGEN	Interval: Once	Occurrences: --	Comments:	Including at CRS onset if applicable
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: Once	Occurrences: --	Comments:	CMV PCR testing is required on D1 of each cycle.
C1D1 is not required if testing is performed during screening.
For participants with no evidence of CMV infection or reactivation in the first 6 cycles, testing requirement will shift to every 3 cycles from C7D1 onward.
		  	HCG QUALITATIVE, URINE SCREEN	Interval: Once	Occurrences: --	Comments:	Participants of childbearing potential.
Within 24 hours prior to C1D1, thereafter, Q4W (Q2W for participants with irregular menses) and as clinically indicated. 
4 weeks after the last dose of lenalidomide
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	During treatment:
· At each disease evaluation for the first 6 months and every third disease evaluation collection thereafter
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	During treatment:
· Whenever CR or sCR are suspected
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	During treatment:
· If measurable disease by light chain: at each disease evaluation collection
·  Others: whenever CR or sCR are suspected
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier
		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Bone marrow aspirate and/or core biopsy.During treatment:
· Whenever CR or sCR are suspected
· Time of PD
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Bone marrow aspirate for MRD (Randomized Part). During treatment:
Whenever CR or sCR are suspected:
·  For participants with confirmed CR or sCR, MRD by NGS will be performed at 12, 24, and 36 months post C1D1 (±1 month) until PD or start of SST
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Predose on the day of dosing.C1D1, C2D1, C4D1, C7D1
		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Response-based.· 
Time of suspected CR or sCR. For participants with confirmed CR or sCR: 12, 24, and 36 months post-C1D1 (±1 month) until PD or start of SST. Time of PD
		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Immune profiling (whole blood).Predose on the day of dosing. C1D1, C4D1, C7D1
		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Immune profiling (whole blood).Response-based. Time of PD
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: Until discontinued	Occurrences: --	Comments:	If the dose of any agent has been delayed for any reason, contact the provider to ensure all agents are ordered appropriately
		  	TREATMENT CONDITIONS 10	Interval: Until discontinued	Occurrences: --	Comments:	HOLD and NOTIFY provider if:
-  ANC LESS than 1,000
-  Platelets LESS than 100,000
		  	TREATMENT CONDITIONS 11	Interval: Until discontinued	Occurrences: --	Comments:	Monitor for neurotoxicity such as somnolence, confusion, hallucinations, blurred vision, and seizures. Notify the provider if any of these symptoms exist.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	ONC PROVIDER COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Montelukast (SINGULAIR) 10 mg once can be added at the discretion of the provider
		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				☐	diphenhydrAMINE (BENADRYL) tablet	Dose: --	Route: oral	once for 1 dose	Start: S				☑	diphenhydrAMINE (BENADRYL) injection 50 mg	Dose: 50 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	If patient cant tolerate oral medications, contact provider to add an IV alternative		☑	dexAMETHasone (DECADRON) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S			Instructions:	If patient cant tolerate oral medications, contact provider to add an IV alternative			Chemotherapy
  	INV-DARATUMUMAB/HYALURONIDASE (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains Daratumumab SC. Administer subcutaneously over 3-5 minutes. No filter required. Stable 12 hours at room temperature or 24 hours refrigerated.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: Until discontinued	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 83	Interval: Until discontinued	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 4	Interval: Until discontinued	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	Start: S				  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					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.				Day 2	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: Until discontinued	Occurrences: --	Comments:	IP admission needed for teclistamab on days 2, 4, 8 and need to be monitored for 48 hours post dose given on day 8.
		  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Physical examination. Symptom directed. AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas. Imaging/physical exam
		  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --	Comments:	Neurologic exam including ICE Tool.C1D2 (applies to Tec-DR and Tal-DR only).
As clinically indicated thereafter
		  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	RESEARCH -  PULSE OXIMETRY	Interval: Daily	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	ONC NURSING COMMUNICATION 52	Interval: Until discontinued	Occurrences: --	Comments:	MRU. Collected continuously from the start of study treatment until 30 days after the last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 54	Interval: Until discontinued	Occurrences: --	Comments:	TTSP.At time of confirmed PD, document progression-associated symptoms and concomitant medications
		  	ONC NURSING COMMUNICATION 67	Interval: Until discontinued	Occurrences: --	Comments:	Adverse Events.Continuous until 30 days after last dose or until the start of SST, if earlier; thereafter, continue to report any AEs/SAEs related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 68	Interval: Until discontinued	Occurrences: --	Comments:	Second primary malignancy. Continuous from the time Second primary malignancy of signing of ICF
		  	ONC NURSING COMMUNICATION 69	Interval: Until discontinued	Occurrences: --	Comments:	Continuous until 30 days after last dose; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS
			Other
  	ONC NURSING COMMUNICATION 73	Interval: Until discontinued	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas.For participants with a history of plasmacytoma:
·  For assessment by physical examination (if applicable) Q4W (±1 week) for the first 2 years from C1D1 and then Q8W (±1 week) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST
·  For assessment by radiology, Q12W (±2 weeks) for the first 2 years from C1D1 and then Q16W (±4 weeks) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST.
As clinically indicated for other participants
			Nursing Orders
  	ONC NURSING COMMUNICATION 72	Interval: Until discontinued	Occurrences: --	Comments:	Study visit.If the visit occurs later than planned, adjust subsequent visit(s) accordingly or skip dose per protocol
		  	ONC NURSING COMMUNICATION 8	Interval: Until discontinued	Occurrences: --	Comments:	When daratumumab SC and talquetamab are to be administered on the same day, daratumumab SC should be administered first.
The following intervals between daratumumab SC and talquetamab should be followed:
-         On Cycle 1 Day 8, talquetamab should be administered >=3 hours after daratumumab SC.
-         Note the requirements for repetition of the required pretreatment medications if >4 hours (steroid) or >6 hours (antihistamine, antipyretic) have elapsed since prior administration of the pretreatment medication (see Table 14)
Thereafter, talquetamab should be administered at least 15 minutes after daratumumab SC
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --	Comments:	CBC with differential.
Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --	Comments:	As clinically indicated. Perform only on participants who are treated with statins
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: Until discontinued	Occurrences: --	Comments:	If the dose of any agent has been delayed for any reason, contact the provider to ensure all agents are ordered appropriately
		  	TREATMENT CONDITIONS 10	Interval: Until discontinued	Occurrences: --	Comments:	HOLD and NOTIFY provider if:
-  ANC LESS than 1,000
-  Platelets LESS than 100,000
		  	TREATMENT CONDITIONS 11	Interval: Until discontinued	Occurrences: --	Comments:	Monitor for neurotoxicity such as somnolence, confusion, hallucinations, blurred vision, and seizures. Notify the provider if any of these symptoms exist.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	ONC PROVIDER COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Montelukast (SINGULAIR) 10 mg once can be added at the discretion of the provider
		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				☐	diphenhydrAMINE (BENADRYL) tablet	Dose: --	Route: oral	once for 1 dose	Start: S				☑	diphenhydrAMINE (BENADRYL) injection 50 mg	Dose: 50 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	If patient cant tolerate oral medications, contact provider to add an IV alternative		☑	dexAMETHasone (DECADRON) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S			Instructions:	If patient cant tolerate oral medications, contact provider to add an IV alternative			Chemotherapy
  	INV-TALQUETAMAB 2 MG/ML (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 0.01 mg/kg (Treatment Plan)	Dose: 0.01 mg/kg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains talquetamab 2 mg/mL (low concentration). Administer via subcutaneous injection Max 2 mL per syringe. May split injection into multiple syringes. Prepared syringe stable 20 hours at room temp or refrigerated.				Day 4	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: Until discontinued	Occurrences: --	Comments:	IP admission needed for teclistamab on days 2, 4, 8 and need to be monitored for 48 hours post dose given on day 8.
		  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Physical examination. Symptom directed. AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas. Imaging/physical exam
		  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --	Comments:	Neurologic exam including ICE Tool.C1D2 (applies to Tec-DR and Tal-DR only).
As clinically indicated thereafter
		  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	RESEARCH -  PULSE OXIMETRY	Interval: Daily	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	ONC NURSING COMMUNICATION 52	Interval: Until discontinued	Occurrences: --	Comments:	MRU. Collected continuously from the start of study treatment until 30 days after the last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 54	Interval: Until discontinued	Occurrences: --	Comments:	TTSP.At time of confirmed PD, document progression-associated symptoms and concomitant medications
		  	ONC NURSING COMMUNICATION 67	Interval: Until discontinued	Occurrences: --	Comments:	Adverse Events.Continuous until 30 days after last dose or until the start of SST, if earlier; thereafter, continue to report any AEs/SAEs related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 68	Interval: Until discontinued	Occurrences: --	Comments:	Second primary malignancy. Continuous from the time Second primary malignancy of signing of ICF
		  	ONC NURSING COMMUNICATION 69	Interval: Until discontinued	Occurrences: --	Comments:	Continuous until 30 days after last dose; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS
			Other
  	ONC NURSING COMMUNICATION 73	Interval: Until discontinued	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas.For participants with a history of plasmacytoma:
·  For assessment by physical examination (if applicable) Q4W (±1 week) for the first 2 years from C1D1 and then Q8W (±1 week) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST
·  For assessment by radiology, Q12W (±2 weeks) for the first 2 years from C1D1 and then Q16W (±4 weeks) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST.
As clinically indicated for other participants
			Nursing Orders
  	ONC NURSING COMMUNICATION 72	Interval: Until discontinued	Occurrences: --	Comments:	Study visit.If the visit occurs later than planned, adjust subsequent visit(s) accordingly or skip dose per protocol
		  	ONC NURSING COMMUNICATION 8	Interval: Until discontinued	Occurrences: --	Comments:	When daratumumab SC and talquetamab are to be administered on the same day, daratumumab SC should be administered first.
The following intervals between daratumumab SC and talquetamab should be followed:
-         On Cycle 1 Day 8, talquetamab should be administered >=3 hours after daratumumab SC.
-         Note the requirements for repetition of the required pretreatment medications if >4 hours (steroid) or >6 hours (antihistamine, antipyretic) have elapsed since prior administration of the pretreatment medication (see Table 14)
Thereafter, talquetamab should be administered at least 15 minutes after daratumumab SC
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with differential.
Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	GGT	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	LDH	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Lipase or amylase.Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
Lipase or Amylase
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Lipase or amylase.Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
Lipase or Amylase
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	TLS-related.
Perform <=72 hours before dosing
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	C1D1, as clinically indicated thereafter. Perform only on participants who are treated with statins
		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: Until discontinued	Occurrences: --	Comments:	If the dose of any agent has been delayed for any reason, contact the provider to ensure all agents are ordered appropriately
		  	TREATMENT CONDITIONS 10	Interval: Until discontinued	Occurrences: --	Comments:	HOLD and NOTIFY provider if:
-  ANC LESS than 1,000
-  Platelets LESS than 100,000
		  	TREATMENT CONDITIONS 11	Interval: Until discontinued	Occurrences: --	Comments:	Monitor for neurotoxicity such as somnolence, confusion, hallucinations, blurred vision, and seizures. Notify the provider if any of these symptoms exist.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	ONC PROVIDER COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Montelukast (SINGULAIR) 10 mg once can be added at the discretion of the provider
		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				☐	diphenhydrAMINE (BENADRYL) tablet	Dose: --	Route: oral	once for 1 dose	Start: S				☑	diphenhydrAMINE (BENADRYL) injection 50 mg	Dose: 50 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	If patient cant tolerate oral medications, contact provider to add an IV alternative		☑	dexAMETHasone (DECADRON) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S			Instructions:	If patient cant tolerate oral medications, contact provider to add an IV alternative			Chemotherapy
  	INV-TALQUETAMAB 2 MG/ML (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 0.06 mg/kg (Treatment Plan)	Dose: 0.06 mg/kg	Route: subcutaneous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains talquetamab 2 mg/mL (low concentration). Administer via subcutaneous injection Max 2 mL per syringe. May split injection into multiple syringes. Prepared syringe stable 20 hours at room temp or refrigerated.				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: Until discontinued	Occurrences: --	Comments:	IP admission needed for teclistamab on days 2, 4, 8 and need to be monitored for 48 hours post dose given on day 8.
		  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Physical examination. Symptom directed. AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas. Imaging/physical exam
		  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --	Comments:	Neurologic exam including ICE Tool.C1D2 (applies to Tec-DR and Tal-DR only).
As clinically indicated thereafter
		  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	RESEARCH -  PULSE OXIMETRY	Interval: Daily	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	ONC NURSING COMMUNICATION 72	Interval: Until discontinued	Occurrences: --	Comments:	PRO-CTCAE. Through Cycle 6 unless stopped earlier at the start of SST
		  	ONC NURSING COMMUNICATION 52	Interval: Until discontinued	Occurrences: --	Comments:	MRU. Collected continuously from the start of study treatment until 30 days after the last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 54	Interval: Until discontinued	Occurrences: --	Comments:	TTSP.At time of confirmed PD, document progression-associated symptoms and concomitant medications
		  	ONC NURSING COMMUNICATION 67	Interval: Until discontinued	Occurrences: --	Comments:	Adverse Events.Continuous until 30 days after last dose or until the start of SST, if earlier; thereafter, continue to report any AEs/SAEs related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 68	Interval: Until discontinued	Occurrences: --	Comments:	Second primary malignancy. Continuous from the time Second primary malignancy of signing of ICF
		  	ONC NURSING COMMUNICATION 69	Interval: Until discontinued	Occurrences: --	Comments:	Continuous until 30 days after last dose; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 73	Interval: Until discontinued	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas.For participants with a history of plasmacytoma:
·  For assessment by physical examination (if applicable) Q4W (±1 week) for the first 2 years from C1D1 and then Q8W (±1 week) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST
·  For assessment by radiology, Q12W (±2 weeks) for the first 2 years from C1D1 and then Q16W (±4 weeks) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST.
As clinically indicated for other participants
		  	ONC NURSING COMMUNICATION 72	Interval: Until discontinued	Occurrences: --	Comments:	Study visit.If the visit occurs later than planned, adjust subsequent visit(s) accordingly or skip dose per protocol
		  	ONC NURSING COMMUNICATION 8	Interval: Until discontinued	Occurrences: --	Comments:	When daratumumab SC and talquetamab are to be administered on the same day, daratumumab SC should be administered first.
The following intervals between daratumumab SC and talquetamab should be followed:
-         On Cycle 1 Day 8, talquetamab should be administered >=3 hours after daratumumab SC.
-         Note the requirements for repetition of the required pretreatment medications if >4 hours (steroid) or >6 hours (antihistamine, antipyretic) have elapsed since prior administration of the pretreatment medication (see Table 14)
-         Thereafter, talquetamab should be administered at least 15 minutes after daratumumab SC
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with differential.
Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	GGT	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	LDH	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Lipase or amylase.Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
Lipase or Amylase
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Lipase or amylase.Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
Lipase or Amylase
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	TLS-related.
Perform <=72 hours before dosing
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	C1D1, as clinically indicated thereafter. Perform only on participants who are treated with statins
		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: Until discontinued	Occurrences: --	Comments:	If the dose of any agent has been delayed for any reason, contact the provider to ensure all agents are ordered appropriately
			Treatment Conditions
  	TREATMENT CONDITIONS 10	Interval: Until discontinued	Occurrences: --	Comments:	HOLD and NOTIFY provider if:
-  ANC LESS than 1,000
-  Platelets LESS than 100,000
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	ONC PROVIDER COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Montelukast (SINGULAIR) 10 mg once can be added at the discretion of the provider
		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				☐	diphenhydrAMINE (BENADRYL) tablet	Dose: --	Route: oral	once for 1 dose	Start: S				☑	diphenhydrAMINE (BENADRYL) injection 50 mg	Dose: 50 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	If patient cant tolerate oral medications, contact provider to add an IV alternative		☑	dexAMETHasone (DECADRON) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S			Instructions:	If patient cant tolerate oral medications, contact provider to add an IV alternative			Chemotherapy
  	INV-DARATUMUMAB/HYALURONIDASE (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains Daratumumab SC. Administer subcutaneously over 3-5 minutes. No filter required. Stable 12 hours at room temperature or 24 hours refrigerated.			Chemotherapy
  	INV-TALQUETAMAB 40 MG/ML (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 0.4 mg/kg (Treatment Plan)	Dose: 0.4 mg/kg	Route: subcutaneous	once for 1 dose			Offset: 4 Hours	Instructions:	Prepared syringe contains talquetamab 40 mg/mL (high concentration). Administer via subcutaneous injection Max 2 mL per syringe. May split injection into multiple syringes. Prepared syringe stable 20 hours at room temp or refrigerated.				Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with differential.
Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	LDH	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Lipase or amylase.Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
Lipase or Amylase
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Lipase or amylase.Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
Lipase or Amylase
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	C1D1, as clinically indicated thereafter. Perform only on participants who are treated with statins
		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Physical examination. Symptom directed. As clinically indicated
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas. Imaging/physical exam
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Neurologic examination including ICE Tool
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PRO-CTCAE. Through Cycle 6 unless stopped earlier at the start of SST
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	MRU. Collected continuously from the start of study treatment until 30 days after the last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	TTSP.At time of confirmed PD, document progression-associated symptoms and concomitant medications
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Adverse Events.Continuous until 30 days after last dose or until the start of SST, if earlier; thereafter, continue to report any AEs/SAEs related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Second primary malignancy. Continuous from the time Second primary malignancy of signing of ICF
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Concomitant therapy. Continuous until 30 days after last dose; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	Study visit.If the visit occurs later than planned, adjust subsequent visit(s) accordingly or skip dose per protocol
		  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas.For participants with a history of plasmacytoma:
·  For assessment by physical examination (if applicable) Q4W (±1 week) for the first 2 years from C1D1 and then Q8W (±1 week) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST
·  For assessment by radiology, Q12W (±2 weeks) for the first 2 years from C1D1 and then Q16W (±4 weeks) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST.
As clinically indicated for other participants
		  	ONC NURSING COMMUNICATION 8	Interval: Until discontinued	Occurrences: --	Comments:	When daratumumab SC and talquetamab are to be administered on the same day, daratumumab SC should be administered first.
The following intervals between daratumumab SC and talquetamab should be followed:
-         On Cycle 1 Day 8, talquetamab should be administered >=3 hours after daratumumab SC.
-         Note the requirements for repetition of the required pretreatment medications if >4 hours (steroid) or >6 hours (antihistamine, antipyretic) have elapsed since prior administration of the pretreatment medication (see Table 14)
Thereafter, talquetamab should be administered at least 15 minutes after daratumumab SC
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Talquetamab (PK and ADA).Predose on the day of dosing. C1D1, C1D15, C4D1, C7D1, C10D1, C13D1, C25D1, EOT, Follow up (8 weeks after last dose).C1D1, C1D15, C4D1, C7D1, C10D1, C13D1, C25D1, EOT, Follow up (8 weeks after last dose). To be collected before administration of daratumumab SC
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Talquetamab (PK and ADA).Suspected Grade GREATER than or EQUAL to 3 sARR. Collect additional PK/immunogenicity sample as soon as Grade >=3 teclistamab- or talquetamab-related sARR is detected, if feasible
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Talquetamab (PK and ADA)
	
	Suspected GREATER than or EQUAL to 3 CRS or Grade GREATER than or EQUAL to 3 neurotoxicity/ICANS.
Collect additional PK/immunogenicity sample as soon as GREATER than or EQUAL to 3 CRS or Grade LESS than or EQUAL to 3 teclistamab- or talquetamab-related neurotoxicity/ICANS is detected, if feasible.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	If the dose of any agent has been delayed for any reason, contact the provider to ensure all agents are ordered appropriately
			Treatment Conditions
  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and NOTIFY provider if:
-  ANC LESS than 1,000
-  Platelets LESS than 100,000
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Montelukast (SINGULAIR) 10 mg once can be added at the discretion of the provider
		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 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				☐	diphenhydrAMINE (BENADRYL) injection 50 mg	Dose: 50 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	If patient cant tolerate oral medications, contact provider to add an IV alternative			Chemotherapy
  	INV-DARATUMUMAB/HYALURONIDASE (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains Daratumumab SC. Administer subcutaneously over 3-5 minutes. No filter required. Stable 12 hours at room temperature or 24 hours refrigerated.			Chemotherapy
  	INV-TALQUETAMAB 40 MG/ML (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 0.8 mg/kg (Treatment Plan)	Dose: 0.8 mg/kg	Route: subcutaneous	once for 1 dose			Offset: 75 Minutes	Instructions:	Prepared syringe contains talquetamab 40 mg/mL (high concentration). Administer via subcutaneous injection Max 2 mL per syringe. May split injection into multiple syringes. Prepared syringe stable 20 hours at room temp or refrigerated.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 22	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Physical examination. Symptom directed. As clinically indicated
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas. Imaging/physical exam
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Neurologic examination including ICE Tool
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PRO-CTCAE. Through Cycle 6 unless stopped earlier at the start of SST
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	MRU. Collected continuously from the start of study treatment until 30 days after the last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	TTSP.At time of confirmed PD, document progression-associated symptoms and concomitant medications
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Adverse Events.Continuous until 30 days after last dose or until the start of SST, if earlier; thereafter, continue to report any AEs/SAEs related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Second primary malignancy. Continuous from the time Second primary malignancy of signing of ICF
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Concomitant therapy. Continuous until 30 days after last dose; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	Study visit.If the visit occurs later than planned, adjust subsequent visit(s) accordingly or skip dose per protocol
		  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas.For participants with a history of plasmacytoma:
·  For assessment by physical examination (if applicable) Q4W (±1 week) for the first 2 years from C1D1 and then Q8W (±1 week) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST
·  For assessment by radiology, Q12W (±2 weeks) for the first 2 years from C1D1 and then Q16W (±4 weeks) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST.
As clinically indicated for other participants
		  	ONC NURSING COMMUNICATION 8	Interval: Until discontinued	Occurrences: --	Comments:	When daratumumab SC and talquetamab are to be administered on the same day, daratumumab SC should be administered first.
The following intervals between daratumumab SC and talquetamab should be followed:
-         On Cycle 1 Day 8, talquetamab should be administered >=3 hours after daratumumab SC.
-         Note the requirements for repetition of the required pretreatment medications if >4 hours (steroid) or >6 hours (antihistamine, antipyretic) have elapsed since prior administration of the pretreatment medication (see Table 14)
Thereafter, talquetamab should be administered at least 15 minutes after daratumumab SC
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with differential.
Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	LDH	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Lipase or amylase.Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
Lipase or Amylase
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Lipase or amylase.Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
Lipase or Amylase
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	C1D1, as clinically indicated thereafter. Perform only on participants who are treated with statins
		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	If the dose of any agent has been delayed for any reason, contact the provider to ensure all agents are ordered appropriately
			Treatment Conditions
  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and NOTIFY provider if:
-  ANC LESS than 1,000
-  Platelets LESS than 100,000
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Montelukast (SINGULAIR) 10 mg once can be added at the discretion of the provider
		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 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				☐	diphenhydrAMINE (BENADRYL) injection 50 mg	Dose: 50 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	If patient cant tolerate oral medications, contact provider to add an IV alternative			Chemotherapy
  	INV-DARATUMUMAB/HYALURONIDASE (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains Daratumumab SC. Administer subcutaneously over 3-5 minutes. No filter required. Stable 12 hours at room temperature or 24 hours refrigerated.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 2	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 4 days x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:64007957MMY3005_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***64007957MMY3005*** Treatment: Refer to Section (***6.9 Dose Interruption and Dose Reduction***) Management of AEs. Protocol Access Hyperlink: 64007957MMY3005_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Physical examination. Symptom directed. AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas. Imaging/physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Neurologic examination including ICE Tool.C1D2 (applies to Tec-DR and Tal-DR only).
As clinically indicated thereafter
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PRO-CTCAE. Through Cycle 6 unless stopped earlier at the start of SST
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	MRU. Collected continuously from the start of study treatment until 30 days after the last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	TTSP.At time of confirmed PD, document progression-associated symptoms and concomitant medications
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Adverse Events.Continuous until 30 days after last dose or until the start of SST, if earlier; thereafter, continue to report any AEs/SAEs related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Second primary malignancy. Continuous from the time Second primary malignancy of signing of ICF
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Continuous until 30 days after last dose; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	SST.Follow up (every 28 days), Follow up (every 16 weeks)
		  	ONC NURSING COMMUNICATION 71	Interval: --	Occurrences: --	Comments:	Survival.Q16W following confirmed disease progression or the EOT Visit
		  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	Study visit.If the visit occurs later than planned, adjust subsequent visit(s) accordingly or skip dose per protocol
		  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas.For participants with a history of plasmacytoma:
·  For assessment by physical examination (if applicable) Q4W (±1 week) for the first 2 years from C1D1 and then Q8W (±1 week) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST
·  For assessment by radiology, Q12W (±2 weeks) for the first 2 years from C1D1 and then Q16W (±4 weeks) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST.
As clinically indicated for other participants
		  	ONC NURSING COMMUNICATION 8	Interval: Until discontinued	Occurrences: --	Comments:	When daratumumab SC and talquetamab are to be administered on the same day, daratumumab SC should be administered first.
The following intervals between daratumumab SC and talquetamab should be followed:
-         On Cycle 1 Day 8, talquetamab should be administered >=3 hours after daratumumab SC.
-         Note the requirements for repetition of the required pretreatment medications if >4 hours (steroid) or >6 hours (antihistamine, antipyretic) have elapsed since prior administration of the pretreatment medication (see Table 14)
Thereafter, talquetamab should be administered at least 15 minutes after daratumumab SC
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Quantitative immunoglobulins (IgA, IgG, IgM).During treatment:
·  At each disease evaluation for the first 6 months and every third disease evaluation collection thereafter
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate and/or core biopsy .During treatment:
· Whenever CR or sCR are suspected
·  Time of PD
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate for MRD (Randomized Part). Fresh bone marrow aspirate should be sent to the central laboratory for MRD assessment. During treatment:
Whenever CR or sCR are suspected:
·  For participants with confirmed CR or sCR, MRD by NGS will be performed at 12, 24, and 36 months post C1D1 (±1 month) until PD or start of SST
At EOT or Follow-up:
·  Until confirmed PD or SST, whichever occurs earlier)
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Circulating markers (serum/ plasma). Predose on the day of dosing.C1D1, C2D1, C4D1, C7D1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Circulating markers (serum/ plasma). ·  Time of suspected CR or sCR
·  For participants with confirmed CR or sCR: 12, 24, and 36 months post-C1D1 (±1 month) until PD or start of SST
Time of PD
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with differential.
Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	GGT	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	LDH	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Lipase or amylase.Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
Lipase or Amylase
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Lipase or amylase.Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
Lipase or Amylase
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	C1D1, as clinically indicated thereafter. Perform only on participants who are treated with statins
		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	CMV PCR testing is required on D1 of each cycle.
C1D1 is not required if testing is performed during screening.
For participants with no evidence of CMV infection or reactivation in the first 6 cycles, testing requirement will shift to every 3 cycles from C7D1 onward.
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential.
Within 24 hours prior to C1D1, thereafter, Q4W (Q2W for participants with irregular menses) and as clinically indicated. 
4 weeks after the last dose of lenalidomide
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	If the dose of any agent has been delayed for any reason, contact the provider to ensure all agents are ordered appropriately
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and NOTIFY provider if:
-  ANC LESS than 1,000
-  Platelets LESS than 100,000
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Monitor for neurotoxicity such as somnolence, confusion, hallucinations, blurred vision, and seizures. Notify the provider if any of these symptoms exist.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Montelukast (SINGULAIR) 10 mg once can be added at the discretion of the provider
		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 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				☐	diphenhydrAMINE (BENADRYL) injection 50 mg	Dose: 50 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	If patient cant tolerate oral medications, contact provider to add an IV alternative			Chemotherapy
  	INV-DARATUMUMAB/HYALURONIDASE (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains Daratumumab SC. Administer subcutaneously over 3-5 minutes. No filter required. Stable 12 hours at room temperature or 24 hours refrigerated.			Chemotherapy
  	INV-TALQUETAMAB 40 MG/ML (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 0.8 mg/kg (Treatment Plan)	Dose: 0.8 mg/kg	Route: subcutaneous	once for 1 dose			Offset: 75 Minutes	Instructions:	Prepared syringe contains talquetamab 40 mg/mL (high concentration). Administer via subcutaneous injection Max 2 mL per syringe. May split injection into multiple syringes. Prepared syringe stable 20 hours at room temp or refrigerated.			Chemotherapy
  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	Patient will be prescribed lenalidomide 25 mg PO once daily on days 1-21 of each cycle
			Chemotherapy
  	dexAMETHasone tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Physical examination. Symptom directed. AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas. Imaging/physical exam
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Neurologic examination including ICE Tool.C1D2 (applies to Tec-DR and Tal-DR only).
As clinically indicated thereafter
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PRO-CTCAE. Through Cycle 6 unless stopped earlier at the start of SST
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	MRU. Collected continuously from the start of study treatment until 30 days after the last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	TTSP.At time of confirmed PD, document progression-associated symptoms and concomitant medications
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Adverse Events.Continuous until 30 days after last dose or until the start of SST, if earlier; thereafter, continue to report any AEs/SAEs related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Second primary malignancy. Continuous from the time Second primary malignancy of signing of ICF
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Continuous until 30 days after last dose; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	Study visit.If the visit occurs later than planned, adjust subsequent visit(s) accordingly or skip dose per protocol
		  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas.For participants with a history of plasmacytoma:
·  For assessment by physical examination (if applicable) Q4W (±1 week) for the first 2 years from C1D1 and then Q8W (±1 week) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST
·  For assessment by radiology, Q12W (±2 weeks) for the first 2 years from C1D1 and then Q16W (±4 weeks) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST.
As clinically indicated for other participants
		  	ONC NURSING COMMUNICATION 8	Interval: Until discontinued	Occurrences: --	Comments:	When daratumumab SC and talquetamab are to be administered on the same day, daratumumab SC should be administered first.
The following intervals between daratumumab SC and talquetamab should be followed:
-         On Cycle 1 Day 8, talquetamab should be administered >=3 hours after daratumumab SC.
-         Note the requirements for repetition of the required pretreatment medications if >4 hours (steroid) or >6 hours (antihistamine, antipyretic) have elapsed since prior administration of the pretreatment medication (see Table 14)
Thereafter, talquetamab should be administered at least 15 minutes after daratumumab SC
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with differential.
Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	C1D1, as clinically indicated thereafter. Perform only on participants who are treated with statins
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Quantitative immunoglobulins (IgA, IgG, IgM).During treatment:
·  At each disease evaluation for the first 6 months and every third disease evaluation collection thereafter
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate and/or core biopsy .During treatment:
· Whenever CR or sCR are suspected
·  Time of PD
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate for MRD (Randomized Part). Fresh bone marrow aspirate should be sent to the central laboratory for MRD assessment. During treatment:
Whenever CR or sCR are suspected:
·  For participants with confirmed CR or sCR, MRD by NGS will be performed at 12, 24, and 36 months post C1D1 (±1 month) until PD or start of SST
At EOT or Follow-up:
·  Until confirmed PD or SST, whichever occurs earlier)
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Circulating markers (serum/ plasma). Predose on the day of dosing.C1D1, C2D1, C4D1, C7D1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Circulating markers (serum/ plasma). ·  Time of suspected CR or sCR
·  For participants with confirmed CR or sCR: 12, 24, and 36 months post-C1D1 (±1 month) until PD or start of SST
Time of PD
			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.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	If the dose of any agent has been delayed for any reason, contact the provider to ensure all agents are ordered appropriately
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and NOTIFY provider if:
-  ANC LESS than 1,000
-  Platelets LESS than 100,000
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Monitor for neurotoxicity such as somnolence, confusion, hallucinations, blurred vision, and seizures. Notify the provider if any of these symptoms exist.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Montelukast (SINGULAIR) 10 mg once can be added at the discretion of the provider
		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 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				☐	diphenhydrAMINE (BENADRYL) injection 50 mg	Dose: 50 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	If patient cant tolerate oral medications, contact provider to add an IV alternative			Chemotherapy
  	INV-DARATUMUMAB/HYALURONIDASE (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains Daratumumab SC. Administer subcutaneously over 3-5 minutes. No filter required. Stable 12 hours at room temperature or 24 hours refrigerated.			Chemotherapy
  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	Patient will be prescribed lenalidomide 25 mg PO once daily on days 1-21 of each cycle
			Chemotherapy
  	dexAMETHasone tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Physical examination. Symptom directed. AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas. Imaging/physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Neurologic examination including ICE Tool
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PRO-CTCAE. Through Cycle 6 unless stopped earlier at the start of SST
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	MRU. Collected continuously from the start of study treatment until 30 days after the last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	TTSP.At time of confirmed PD, document progression-associated symptoms and concomitant medications
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Adverse Events.Continuous until 30 days after last dose or until the start of SST, if earlier; thereafter, continue to report any AEs/SAEs related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Second primary malignancy. Continuous from the time Second primary malignancy of signing of ICF
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Continuous until 30 days after last dose; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	Study visit.If the visit occurs later than planned, adjust subsequent visit(s) accordingly or skip dose per protocol
		  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas.For participants with a history of plasmacytoma:
·  For assessment by physical examination (if applicable) Q4W (±1 week) for the first 2 years from C1D1 and then Q8W (±1 week) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST
·  For assessment by radiology, Q12W (±2 weeks) for the first 2 years from C1D1 and then Q16W (±4 weeks) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST.
As clinically indicated for other participants
		  	ONC NURSING COMMUNICATION 8	Interval: Until discontinued	Occurrences: --	Comments:	When daratumumab SC and talquetamab are to be administered on the same day, daratumumab SC should be administered first.
The following intervals between daratumumab SC and talquetamab should be followed:
-         On Cycle 1 Day 8, talquetamab should be administered >=3 hours after daratumumab SC.
-         Note the requirements for repetition of the required pretreatment medications if >4 hours (steroid) or >6 hours (antihistamine, antipyretic) have elapsed since prior administration of the pretreatment medication (see Table 14)
Thereafter, talquetamab should be administered at least 15 minutes after daratumumab SC
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with differential.
Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	C1D1, as clinically indicated thereafter. Perform only on participants who are treated with statins
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Circulating markers (serum/ plasma). Predose on the day of dosing.C1D1, C2D1, C4D1, C7D1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Circulating markers (serum/ plasma). ·  Time of suspected CR or sCR
·  For participants with confirmed CR or sCR: 12, 24, and 36 months post-C1D1 (±1 month) until PD or start of SST
Time of PD
			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.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	If the dose of any agent has been delayed for any reason, contact the provider to ensure all agents are ordered appropriately
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and NOTIFY provider if:
-  ANC LESS than 1,000
-  Platelets LESS than 100,000
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Monitor for neurotoxicity such as somnolence, confusion, hallucinations, blurred vision, and seizures. Notify the provider if any of these symptoms exist.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Montelukast (SINGULAIR) 10 mg once can be added at the discretion of the provider
		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 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				☐	diphenhydrAMINE (BENADRYL) injection 50 mg	Dose: 50 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	If patient cant tolerate oral medications, contact provider to add an IV alternative			Chemotherapy
  	INV-DARATUMUMAB/HYALURONIDASE (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains Daratumumab SC. Administer subcutaneously over 3-5 minutes. No filter required. Stable 12 hours at room temperature or 24 hours refrigerated.			Chemotherapy
  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	Patient will be prescribed lenalidomide 25 mg PO once daily on days 1-21 of each cycle
			Chemotherapy
  	dexAMETHasone tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 22	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:64007957MMY3005_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***64007957MMY3005*** Treatment: Refer to Section (***6.9 Dose Interruption and Dose Reduction***) Management of AEs. Protocol Access Hyperlink: 64007957MMY3005_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Physical examination. Symptom directed. AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas. Imaging/physical exam
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Neurologic examination including ICE Tool.C1D2 (applies to Tec-DR and Tal-DR only).
As clinically indicated thereafter
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PRO-CTCAE. Through Cycle 6 unless stopped earlier at the start of SST
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	MRU. Collected continuously from the start of study treatment until 30 days after the last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	TTSP.At time of confirmed PD, document progression-associated symptoms and concomitant medications
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Adverse Events.Continuous until 30 days after last dose or until the start of SST, if earlier; thereafter, continue to report any AEs/SAEs related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Second primary malignancy. Continuous from the time Second primary malignancy of signing of ICF
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Continuous until 30 days after last dose; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	Study visit.If the visit occurs later than planned, adjust subsequent visit(s) accordingly or skip dose per protocol
		  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas.For participants with a history of plasmacytoma:
·  For assessment by physical examination (if applicable) Q4W (±1 week) for the first 2 years from C1D1 and then Q8W (±1 week) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST
·  For assessment by radiology, Q12W (±2 weeks) for the first 2 years from C1D1 and then Q16W (±4 weeks) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST.
As clinically indicated for other participants
		  	ONC NURSING COMMUNICATION 8	Interval: Until discontinued	Occurrences: --	Comments:	When daratumumab SC and talquetamab are to be administered on the same day, daratumumab SC should be administered first.
The following intervals between daratumumab SC and talquetamab should be followed:
-         On Cycle 1 Day 8, talquetamab should be administered >=3 hours after daratumumab SC.
-         Note the requirements for repetition of the required pretreatment medications if >4 hours (steroid) or >6 hours (antihistamine, antipyretic) have elapsed since prior administration of the pretreatment medication (see Table 14)
Thereafter, talquetamab should be administered at least 15 minutes after daratumumab SC
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with differential.
Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	C1D1, as clinically indicated thereafter. Perform only on participants who are treated with statins
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Quantitative immunoglobulins (IgA, IgG, IgM).During treatment:
·  At each disease evaluation for the first 6 months and every third disease evaluation collection thereafter
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate and/or core biopsy .During treatment:
· Whenever CR or sCR are suspected
·  Time of PD
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate for MRD (Randomized Part). Fresh bone marrow aspirate should be sent to the central laboratory for MRD assessment. During treatment:
Whenever CR or sCR are suspected:
·  For participants with confirmed CR or sCR, MRD by NGS will be performed at 12, 24, and 36 months post C1D1 (±1 month) until PD or start of SST
At EOT or Follow-up:
·  Until confirmed PD or SST, whichever occurs earlier)
			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.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	If the dose of any agent has been delayed for any reason, contact the provider to ensure all agents are ordered appropriately
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and NOTIFY provider if:
-  ANC LESS than 1,000
-  Platelets LESS than 100,000
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Monitor for neurotoxicity such as somnolence, confusion, hallucinations, blurred vision, and seizures. Notify the provider if any of these symptoms exist.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Montelukast (SINGULAIR) 10 mg once can be added at the discretion of the provider
		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 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				☐	diphenhydrAMINE (BENADRYL) injection 50 mg	Dose: 50 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	If patient cant tolerate oral medications, contact provider to add an IV alternative			Chemotherapy
  	INV-DARATUMUMAB/HYALURONIDASE (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains Daratumumab SC. Administer subcutaneously over 3-5 minutes. No filter required. Stable 12 hours at room temperature or 24 hours refrigerated.			Chemotherapy
  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	Patient will be prescribed lenalidomide 25 mg PO once daily on days 1-21 of each cycle
			Chemotherapy
  	dexAMETHasone tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 3	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Please ensure patient has a script for dexamethasone 20 mg to take on days 8 and 22 of cycle 3 only
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:64007957MMY3005_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***64007957MMY3005*** Treatment: Refer to Section (***6.9 Dose Interruption and Dose Reduction***) Management of AEs. Protocol Access Hyperlink: 64007957MMY3005_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Physical examination. Symptom directed. AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas. Imaging/physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Neurologic examination including ICE Tool
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PRO-CTCAE. Through Cycle 6 unless stopped earlier at the start of SST
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	MRU. Collected continuously from the start of study treatment until 30 days after the last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	TTSP.At time of confirmed PD, document progression-associated symptoms and concomitant medications
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Adverse Events.Continuous until 30 days after last dose or until the start of SST, if earlier; thereafter, continue to report any AEs/SAEs related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Second primary malignancy. Continuous from the time Second primary malignancy of signing of ICF
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Continuous until 30 days after last dose; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	Study visit.If the visit occurs later than planned, adjust subsequent visit(s) accordingly or skip dose per protocol
		  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas.For participants with a history of plasmacytoma:
·  For assessment by physical examination (if applicable) Q4W (±1 week) for the first 2 years from C1D1 and then Q8W (±1 week) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST
·  For assessment by radiology, Q12W (±2 weeks) for the first 2 years from C1D1 and then Q16W (±4 weeks) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST.
As clinically indicated for other participants
		  	ONC NURSING COMMUNICATION 8	Interval: Until discontinued	Occurrences: --	Comments:	When daratumumab SC and talquetamab are to be administered on the same day, daratumumab SC should be administered first.
The following intervals between daratumumab SC and talquetamab should be followed:
-         On Cycle 1 Day 8, talquetamab should be administered >=3 hours after daratumumab SC.
-         Note the requirements for repetition of the required pretreatment medications if >4 hours (steroid) or >6 hours (antihistamine, antipyretic) have elapsed since prior administration of the pretreatment medication (see Table 14)
Thereafter, talquetamab should be administered at least 15 minutes after daratumumab SC
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with differential.
Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	GGT	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	LDH	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Lipase or amylase.Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
Lipase or Amylase
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Lipase or amylase.Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
Lipase or Amylase
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	C1D1, as clinically indicated thereafter. Perform only on participants who are treated with statins
		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	CMV PCR testing is required on D1 of each cycle.
C1D1 is not required if testing is performed during screening.
For participants with no evidence of CMV infection or reactivation in the first 6 cycles, testing requirement will shift to every 3 cycles from C7D1 onward.
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential.
Within 24 hours prior to C1D1, thereafter, Q4W (Q2W for participants with irregular menses) and as clinically indicated. 
4 weeks after the last dose of lenalidomide
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Quantitative immunoglobulins (IgA, IgG, IgM).During treatment:
·  At each disease evaluation for the first 6 months and every third disease evaluation collection thereafter
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate and/or core biopsy .During treatment:
· Whenever CR or sCR are suspected
·  Time of PD
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate for MRD (Randomized Part). Fresh bone marrow aspirate should be sent to the central laboratory for MRD assessment. During treatment:
Whenever CR or sCR are suspected:
·  For participants with confirmed CR or sCR, MRD by NGS will be performed at 12, 24, and 36 months post C1D1 (±1 month) until PD or start of SST
At EOT or Follow-up:
·  Until confirmed PD or SST, whichever occurs earlier)
			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.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	If the dose of any agent has been delayed for any reason, contact the provider to ensure all agents are ordered appropriately
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and NOTIFY provider if:
-  ANC LESS than 1,000
-  Platelets LESS than 100,000
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Monitor for neurotoxicity such as somnolence, confusion, hallucinations, blurred vision, and seizures. Notify the provider if any of these symptoms exist.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Montelukast (SINGULAIR) 10 mg once can be added at the discretion of the provider
		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 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				☐	diphenhydrAMINE (BENADRYL) injection 50 mg	Dose: 50 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	If patient cant tolerate oral medications, contact provider to add an IV alternative			Chemotherapy
  	INV-DARATUMUMAB/HYALURONIDASE (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains Daratumumab SC. Administer subcutaneously over 3-5 minutes. No filter required. Stable 12 hours at room temperature or 24 hours refrigerated.			Chemotherapy
  	INV-TALQUETAMAB 40 MG/ML (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 0.8 mg/kg (Treatment Plan)	Dose: 0.8 mg/kg	Route: subcutaneous	once for 1 dose			Offset: 75 Minutes	Instructions:	Prepared syringe contains talquetamab 40 mg/mL (high concentration). Administer via subcutaneous injection Max 2 mL per syringe. May split injection into multiple syringes. Prepared syringe stable 20 hours at room temp or refrigerated.			Chemotherapy
  	dexAMETHasone tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Please ensure patient has a script for dexamethasone 20 mg to take on days 8 and 22 of cycle 3 only
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Physical examination. Symptom directed. AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas. Imaging/physical exam
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Neurologic examination including ICE Tool.C1D2 (applies to Tec-DR and Tal-DR only).
As clinically indicated thereafter
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PRO-CTCAE. Through Cycle 6 unless stopped earlier at the start of SST
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	MRU. Collected continuously from the start of study treatment until 30 days after the last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	TTSP.At time of confirmed PD, document progression-associated symptoms and concomitant medications
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Adverse Events.Continuous until 30 days after last dose or until the start of SST, if earlier; thereafter, continue to report any AEs/SAEs related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Second primary malignancy. Continuous from the time Second primary malignancy of signing of ICF
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Continuous until 30 days after last dose; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	Study visit.If the visit occurs later than planned, adjust subsequent visit(s) accordingly or skip dose per protocol
		  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas.For participants with a history of plasmacytoma:
·  For assessment by physical examination (if applicable) Q4W (±1 week) for the first 2 years from C1D1 and then Q8W (±1 week) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST
·  For assessment by radiology, Q12W (±2 weeks) for the first 2 years from C1D1 and then Q16W (±4 weeks) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST.
As clinically indicated for other participants
		  	ONC NURSING COMMUNICATION 8	Interval: Until discontinued	Occurrences: --	Comments:	When daratumumab SC and talquetamab are to be administered on the same day, daratumumab SC should be administered first.
The following intervals between daratumumab SC and talquetamab should be followed:
-         On Cycle 1 Day 8, talquetamab should be administered >=3 hours after daratumumab SC.
-         Note the requirements for repetition of the required pretreatment medications if >4 hours (steroid) or >6 hours (antihistamine, antipyretic) have elapsed since prior administration of the pretreatment medication (see Table 14)
Thereafter, talquetamab should be administered at least 15 minutes after daratumumab SC
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with differential.
Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	C1D1, as clinically indicated thereafter. Perform only on participants who are treated with statins
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Talquetamab (PK and ADA).Predose on the day of dosing. C1D1, C1D15, C4D1, C7D1, C10D1, C13D1, C25D1, EOT, Follow up (8 weeks after last dose).C1D1, C1D15, C4D1, C7D1, C10D1, C13D1, C25D1, EOT, Follow up (8 weeks after last dose). To be collected before administration of daratumumab SC
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Talquetamab (PK and ADA).Suspected Grade GREATER than or EQUAL to 3 sARR. Collect additional PK/immunogenicity sample as soon as Grade >=3 teclistamab- or talquetamab-related sARR is detected, if feasible
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Talquetamab (PK and ADA)
	
	Suspected GREATER than or EQUAL to 3 CRS or Grade GREATER than or EQUAL to 3 neurotoxicity/ICANS.
Collect additional PK/immunogenicity sample as soon as GREATER than or EQUAL to 3 CRS or Grade LESS than or EQUAL to 3 teclistamab- or talquetamab-related neurotoxicity/ICANS is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Circulating markers (serum/ plasma). Predose on the day of dosing.C1D1, C2D1, C4D1, C7D1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Circulating markers (serum/ plasma). ·  Time of suspected CR or sCR
·  For participants with confirmed CR or sCR: 12, 24, and 36 months post-C1D1 (±1 month) until PD or start of SST
Time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Quantitative immunoglobulins (IgA, IgG, IgM).During treatment:
·  At each disease evaluation for the first 6 months and every third disease evaluation collection thereafter
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate and/or core biopsy .During treatment:
· Whenever CR or sCR are suspected
·  Time of PD
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate for MRD (Randomized Part). Fresh bone marrow aspirate should be sent to the central laboratory for MRD assessment. During treatment:
Whenever CR or sCR are suspected:
·  For participants with confirmed CR or sCR, MRD by NGS will be performed at 12, 24, and 36 months post C1D1 (±1 month) until PD or start of SST
At EOT or Follow-up:
·  Until confirmed PD or SST, whichever occurs earlier)
			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.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	If the dose of any agent has been delayed for any reason, contact the provider to ensure all agents are ordered appropriately
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and NOTIFY provider if:
-  ANC LESS than 1,000
-  Platelets LESS than 100,000
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Monitor for neurotoxicity such as somnolence, confusion, hallucinations, blurred vision, and seizures. Notify the provider if any of these symptoms exist.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Montelukast (SINGULAIR) 10 mg once can be added at the discretion of the provider
		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 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				☐	diphenhydrAMINE (BENADRYL) injection 50 mg	Dose: 50 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	If patient cant tolerate oral medications, contact provider to add an IV alternative			Chemotherapy
  	INV-DARATUMUMAB/HYALURONIDASE (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains Daratumumab SC. Administer subcutaneously over 3-5 minutes. No filter required. Stable 12 hours at room temperature or 24 hours refrigerated.			Chemotherapy
  	dexAMETHasone tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 4	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:64007957MMY3005_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***64007957MMY3005*** Treatment: Refer to Section (***6.9 Dose Interruption and Dose Reduction***) Management of AEs. Protocol Access Hyperlink: 64007957MMY3005_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Physical examination. Symptom directed. AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas. Imaging/physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Neurologic examination including ICE Tool.C1D2 (applies to Tec-DR and Tal-DR only).
As clinically indicated thereafter
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab are to be administered on the same day, daratumumab SC should be administered first.
The following intervals between daratumumab SC and talquetamab should be followed:
-         On Cycle 1 Day 8, talquetamab should be administered >=3 hours after daratumumab SC.
-         Note the requirements for repetition of the required pretreatment medications if >4 hours (steroid) or >6 hours (antihistamine, antipyretic) have elapsed since prior administration of the pretreatment medication (see Table 14)
Thereafter, talquetamab should be administered at least 15 minutes after daratumumab SC
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	When daratumumab SC and talquetamab are to be administered on the same day, daratumumab SC should be administered first.
The following intervals between daratumumab SC and talquetamab should be followed:
-         On Cycle 1 Day 8, talquetamab should be administered >=3 hours after daratumumab SC.
-         Note the requirements for repetition of the required pretreatment medications if >4 hours (steroid) or >6 hours (antihistamine, antipyretic) have elapsed since prior administration of the pretreatment medication (see Table 14)
Thereafter, talquetamab should be administered at least 15 minutes after daratumumab SC
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PRO-CTCAE. Through Cycle 6 unless stopped earlier at the start of SST
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	MRU. Collected continuously from the start of study treatment until 30 days after the last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	TTSP.At time of confirmed PD, document progression-associated symptoms and concomitant medications
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Adverse Events.Continuous until 30 days after last dose or until the start of SST, if earlier; thereafter, continue to report any AEs/SAEs related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Second primary malignancy. Continuous from the time Second primary malignancy of signing of ICF
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Continuous until 30 days after last dose; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	SST.Follow up (every 28 days), Follow up (every 16 weeks)
		  	ONC NURSING COMMUNICATION 71	Interval: --	Occurrences: --	Comments:	Survival.Q16W following confirmed disease progression or the EOT Visit
		  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	Study visit.If the visit occurs later than planned, adjust subsequent visit(s) accordingly or skip dose per protocol
		  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas.For participants with a history of plasmacytoma:
·  For assessment by physical examination (if applicable) Q4W (±1 week) for the first 2 years from C1D1 and then Q8W (±1 week) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST
·  For assessment by radiology, Q12W (±2 weeks) for the first 2 years from C1D1 and then Q16W (±4 weeks) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST.
As clinically indicated for other participants
		  	ONC NURSING COMMUNICATION 8	Interval: Until discontinued	Occurrences: --	Comments:	When daratumumab SC and talquetamab are to be administered on the same day, daratumumab SC should be administered first.
The following intervals between daratumumab SC and talquetamab should be followed:
-         On Cycle 1 Day 8, talquetamab should be administered >=3 hours after daratumumab SC.
-         Note the requirements for repetition of the required pretreatment medications if >4 hours (steroid) or >6 hours (antihistamine, antipyretic) have elapsed since prior administration of the pretreatment medication (see Table 14)
Thereafter, talquetamab should be administered at least 15 minutes after daratumumab SC
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with differential.
Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	GGT	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	LDH	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Lipase or amylase.Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
Lipase or Amylase
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Lipase or amylase.Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
Lipase or Amylase
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	TLS-related.
Perform <=72 hours before dosing
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	C1D1, as clinically indicated thereafter. Perform only on participants who are treated with statins
		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Talquetamab (PK and ADA).Predose on the day of dosing. C1D1, C1D15, C4D1, C7D1, C10D1, C13D1, C25D1, EOT, Follow up (8 weeks after last dose).C1D1, C1D15, C4D1, C7D1, C10D1, C13D1, C25D1, EOT, Follow up (8 weeks after last dose). To be collected before administration of daratumumab SC
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Talquetamab (PK and ADA).Suspected Grade GREATER than or EQUAL to 3 sARR. Collect additional PK/immunogenicity sample as soon as Grade >=3 teclistamab- or talquetamab-related sARR is detected, if feasible
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Talquetamab (PK and ADA)
	
	Suspected GREATER than or EQUAL to 3 CRS or Grade GREATER than or EQUAL to 3 neurotoxicity/ICANS.
Collect additional PK/immunogenicity sample as soon as GREATER than or EQUAL to 3 CRS or Grade LESS than or EQUAL to 3 teclistamab- or talquetamab-related neurotoxicity/ICANS is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Quantitative immunoglobulins (IgA, IgG, IgM).During treatment:
·  At each disease evaluation for the first 6 months and every third disease evaluation collection thereafter
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	During treatment:
·  If measurable disease by light chain: at each disease evaluation collection
·  Others: whenever CR or sCR are suspected
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	During treatment:
· Whenever CR or sCR are suspected
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate and/or core biopsy .During treatment:
· Whenever CR or sCR are suspected
·  Time of PD
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate for MRD (Randomized Part). Fresh bone marrow aspirate should be sent to the central laboratory for MRD assessment. During treatment:
Whenever CR or sCR are suspected:
·  For participants with confirmed CR or sCR, MRD by NGS will be performed at 12, 24, and 36 months post C1D1 (±1 month) until PD or start of SST
At EOT or Follow-up:
·  Until confirmed PD or SST, whichever occurs earlier)
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Circulating markers (serum/ plasma). Predose on the day of dosing.C1D1, C2D1, C4D1, C7D1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Circulating markers (serum/ plasma). ·  Time of suspected CR or sCR
·  For participants with confirmed CR or sCR: 12, 24, and 36 months post-C1D1 (±1 month) until PD or start of SST
Time of PD
			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.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	If the dose of any agent has been delayed for any reason, contact the provider to ensure all agents are ordered appropriately
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and NOTIFY provider if:
-  ANC LESS than 1,000
-  Platelets LESS than 100,000
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Monitor for neurotoxicity such as somnolence, confusion, hallucinations, blurred vision, and seizures. Notify the provider if any of these symptoms exist.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Montelukast (SINGULAIR) 10 mg once can be added at the discretion of the provider
		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 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				☐	diphenhydrAMINE (BENADRYL) injection 50 mg	Dose: 50 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	If patient cant tolerate oral medications, contact provider to add an IV alternative			Chemotherapy
  	INV-DARATUMUMAB/HYALURONIDASE (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains Daratumumab SC. Administer subcutaneously over 3-5 minutes. No filter required. Stable 12 hours at room temperature or 24 hours refrigerated.			Chemotherapy
  	INV-TALQUETAMAB 40 MG/ML (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 0.8 mg/kg (Treatment Plan)	Dose: 0.8 mg/kg	Route: subcutaneous	once for 1 dose			Offset: 75 Minutes	Instructions:	Prepared syringe contains talquetamab 40 mg/mL (high concentration). Administer via subcutaneous injection Max 2 mL per syringe. May split injection into multiple syringes. Prepared syringe stable 20 hours at room temp or refrigerated.			Chemotherapy
  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	Patient will be prescribed lenalidomide 25 mg PO once daily on days 1-21 of each cycle
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: Until discontinued	Occurrences: --	Comments:	IP admission needed for teclistamab on days 2, 4, 8 and need to be monitored for 48 hours post dose given on day 8.
		  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Physical examination. Symptom directed. AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas. Imaging/physical exam
		  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --	Comments:	Neurologic exam including ICE Tool.C1D2 (applies to Tec-DR and Tal-DR only).
As clinically indicated thereafter
		  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	RESEARCH -  PULSE OXIMETRY	Interval: Daily	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	ONC NURSING COMMUNICATION 72	Interval: Until discontinued	Occurrences: --	Comments:	PRO-CTCAE. Through Cycle 6 unless stopped earlier at the start of SST
		  	ONC NURSING COMMUNICATION 52	Interval: Until discontinued	Occurrences: --	Comments:	MRU. Collected continuously from the start of study treatment until 30 days after the last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 54	Interval: Until discontinued	Occurrences: --	Comments:	TTSP.At time of confirmed PD, document progression-associated symptoms and concomitant medications
		  	ONC NURSING COMMUNICATION 67	Interval: Until discontinued	Occurrences: --	Comments:	Adverse Events.Continuous until 30 days after last dose or until the start of SST, if earlier; thereafter, continue to report any AEs/SAEs related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 68	Interval: Until discontinued	Occurrences: --	Comments:	Second primary malignancy. Continuous from the time Second primary malignancy of signing of ICF
		  	ONC NURSING COMMUNICATION 69	Interval: Until discontinued	Occurrences: --	Comments:	Continuous until 30 days after last dose; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 73	Interval: Until discontinued	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas.For participants with a history of plasmacytoma:
·  For assessment by physical examination (if applicable) Q4W (±1 week) for the first 2 years from C1D1 and then Q8W (±1 week) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST
·  For assessment by radiology, Q12W (±2 weeks) for the first 2 years from C1D1 and then Q16W (±4 weeks) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST.
As clinically indicated for other participants
		  	ONC NURSING COMMUNICATION 72	Interval: Until discontinued	Occurrences: --	Comments:	Study visit.If the visit occurs later than planned, adjust subsequent visit(s) accordingly or skip dose per protocol
		  	ONC NURSING COMMUNICATION 8	Interval: Until discontinued	Occurrences: --	Comments:	When daratumumab SC and talquetamab are to be administered on the same day, daratumumab SC should be administered first.
The following intervals between daratumumab SC and talquetamab should be followed:
-         On Cycle 1 Day 8, talquetamab should be administered >=3 hours after daratumumab SC.
-         Note the requirements for repetition of the required pretreatment medications if >4 hours (steroid) or >6 hours (antihistamine, antipyretic) have elapsed since prior administration of the pretreatment medication (see Table 14)
-         Thereafter, talquetamab should be administered at least 15 minutes after daratumumab SC
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with differential.
Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	C1D1, as clinically indicated thereafter. Perform only on participants who are treated with statins
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Quantitative immunoglobulins (IgA, IgG, IgM).During treatment:
·  At each disease evaluation for the first 6 months and every third disease evaluation collection thereafter
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate and/or core biopsy .During treatment:
· Whenever CR or sCR are suspected
·  Time of PD
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate for MRD (Randomized Part). Fresh bone marrow aspirate should be sent to the central laboratory for MRD assessment. During treatment:
Whenever CR or sCR are suspected:
·  For participants with confirmed CR or sCR, MRD by NGS will be performed at 12, 24, and 36 months post C1D1 (±1 month) until PD or start of SST
At EOT or Follow-up:
·  Until confirmed PD or SST, whichever occurs earlier)
			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.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	If the dose of any agent has been delayed for any reason, contact the provider to ensure all agents are ordered appropriately
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and NOTIFY provider if:
-  ANC LESS than 1,000
-  Platelets LESS than 100,000
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Monitor for neurotoxicity such as somnolence, confusion, hallucinations, blurred vision, and seizures. Notify the provider if any of these symptoms exist.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Montelukast (SINGULAIR) 10 mg once can be added at the discretion of the provider
		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 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				☐	diphenhydrAMINE (BENADRYL) injection 50 mg	Dose: 50 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	If patient cant tolerate oral medications, contact provider to add an IV alternative			Chemotherapy
  	INV-DARATUMUMAB/HYALURONIDASE (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains Daratumumab SC. Administer subcutaneously over 3-5 minutes. No filter required. Stable 12 hours at room temperature or 24 hours refrigerated.			Chemotherapy
  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	Patient will be prescribed lenalidomide 25 mg PO once daily on days 1-21 of each cycle
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 5	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:64007957MMY3005_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***64007957MMY3005*** Treatment: Refer to Section (***6.9 Dose Interruption and Dose Reduction***) Management of AEs. Protocol Access Hyperlink: 64007957MMY3005_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Physical examination. Symptom directed. AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas. Imaging/physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Neurologic examination including ICE Tool
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PRO-CTCAE. Through Cycle 6 unless stopped earlier at the start of SST
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	MRU. Collected continuously from the start of study treatment until 30 days after the last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	TTSP.At time of confirmed PD, document progression-associated symptoms and concomitant medications
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Adverse Events.Continuous until 30 days after last dose or until the start of SST, if earlier; thereafter, continue to report any AEs/SAEs related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Second primary malignancy. Continuous from the time Second primary malignancy of signing of ICF
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Continuous until 30 days after last dose; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	Study visit.If the visit occurs later than planned, adjust subsequent visit(s) accordingly or skip dose per protocol
		  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas.For participants with a history of plasmacytoma:
·  For assessment by physical examination (if applicable) Q4W (±1 week) for the first 2 years from C1D1 and then Q8W (±1 week) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST
·  For assessment by radiology, Q12W (±2 weeks) for the first 2 years from C1D1 and then Q16W (±4 weeks) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST.
As clinically indicated for other participants
		  	ONC NURSING COMMUNICATION 8	Interval: Until discontinued	Occurrences: --	Comments:	When daratumumab SC and talquetamab are to be administered on the same day, daratumumab SC should be administered first.
The following intervals between daratumumab SC and talquetamab should be followed:
-         On Cycle 1 Day 8, talquetamab should be administered >=3 hours after daratumumab SC.
-         Note the requirements for repetition of the required pretreatment medications if >4 hours (steroid) or >6 hours (antihistamine, antipyretic) have elapsed since prior administration of the pretreatment medication (see Table 14)
Thereafter, talquetamab should be administered at least 15 minutes after daratumumab SC
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with differential.
Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	GGT	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	LDH	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Lipase or amylase.Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
Lipase or Amylase
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Lipase or amylase.Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
Lipase or Amylase
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	C1D1, as clinically indicated thereafter. Perform only on participants who are treated with statins
		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	CMV PCR testing is required on D1 of each cycle.
C1D1 is not required if testing is performed during screening.
For participants with no evidence of CMV infection or reactivation in the first 6 cycles, testing requirement will shift to every 3 cycles from C7D1 onward.
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential.
Within 24 hours prior to C1D1, thereafter, Q4W (Q2W for participants with irregular menses) and as clinically indicated. 
4 weeks after the last dose of lenalidomide
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Quantitative immunoglobulins (IgA, IgG, IgM).During treatment:
·  At each disease evaluation for the first 6 months and every third disease evaluation collection thereafter
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	During treatment:
·  If measurable disease by light chain: at each disease evaluation collection
·  Others: whenever CR or sCR are suspected
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	During treatment:
· Whenever CR or sCR are suspected
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate and/or core biopsy .During treatment:
· Whenever CR or sCR are suspected
·  Time of PD
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate for MRD (Randomized Part). Fresh bone marrow aspirate should be sent to the central laboratory for MRD assessment. During treatment:
Whenever CR or sCR are suspected:
·  For participants with confirmed CR or sCR, MRD by NGS will be performed at 12, 24, and 36 months post C1D1 (±1 month) until PD or start of SST
At EOT or Follow-up:
·  Until confirmed PD or SST, whichever occurs earlier)
			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.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	If the dose of any agent has been delayed for any reason, contact the provider to ensure all agents are ordered appropriately
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and NOTIFY provider if:
-  ANC LESS than 1,000
-  Platelets LESS than 100,000
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Monitor for neurotoxicity such as somnolence, confusion, hallucinations, blurred vision, and seizures. Notify the provider if any of these symptoms exist.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Montelukast (SINGULAIR) 10 mg once can be added at the discretion of the provider
		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 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				☐	diphenhydrAMINE (BENADRYL) injection 50 mg	Dose: 50 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	If patient cant tolerate oral medications, contact provider to add an IV alternative			Chemotherapy
  	INV-DARATUMUMAB/HYALURONIDASE (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains Daratumumab SC. Administer subcutaneously over 3-5 minutes. No filter required. Stable 12 hours at room temperature or 24 hours refrigerated.			Chemotherapy
  	INV-TALQUETAMAB 40 MG/ML (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 0.8 mg/kg (Treatment Plan)	Dose: 0.8 mg/kg	Route: subcutaneous	once for 1 dose			Offset: 75 Minutes	Instructions:	Prepared syringe contains talquetamab 40 mg/mL (high concentration). Administer via subcutaneous injection Max 2 mL per syringe. May split injection into multiple syringes. Prepared syringe stable 20 hours at room temp or refrigerated.			Chemotherapy
  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	Patient will be prescribed lenalidomide 25 mg PO once daily on days 1-21 of each cycle
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Physical examination. Symptom directed. AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas. Imaging/physical exam
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Neurologic examination including ICE Tool.C1D2 (applies to Tec-DR and Tal-DR only).
As clinically indicated thereafter
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PRO-CTCAE. Through Cycle 6 unless stopped earlier at the start of SST
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	MRU. Collected continuously from the start of study treatment until 30 days after the last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	TTSP.At time of confirmed PD, document progression-associated symptoms and concomitant medications
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Adverse Events.Continuous until 30 days after last dose or until the start of SST, if earlier; thereafter, continue to report any AEs/SAEs related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Second primary malignancy. Continuous from the time Second primary malignancy of signing of ICF
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Continuous until 30 days after last dose; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	Study visit.If the visit occurs later than planned, adjust subsequent visit(s) accordingly or skip dose per protocol
		  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas.For participants with a history of plasmacytoma:
·  For assessment by physical examination (if applicable) Q4W (±1 week) for the first 2 years from C1D1 and then Q8W (±1 week) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST
·  For assessment by radiology, Q12W (±2 weeks) for the first 2 years from C1D1 and then Q16W (±4 weeks) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST.
As clinically indicated for other participants
		  	ONC NURSING COMMUNICATION 8	Interval: Until discontinued	Occurrences: --	Comments:	When daratumumab SC and talquetamab are to be administered on the same day, daratumumab SC should be administered first.
The following intervals between daratumumab SC and talquetamab should be followed:
-         On Cycle 1 Day 8, talquetamab should be administered >=3 hours after daratumumab SC.
-         Note the requirements for repetition of the required pretreatment medications if >4 hours (steroid) or >6 hours (antihistamine, antipyretic) have elapsed since prior administration of the pretreatment medication (see Table 14)
Thereafter, talquetamab should be administered at least 15 minutes after daratumumab SC
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with differential.
Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	C1D1, as clinically indicated thereafter. Perform only on participants who are treated with statins
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Quantitative immunoglobulins (IgA, IgG, IgM).During treatment:
·  At each disease evaluation for the first 6 months and every third disease evaluation collection thereafter
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate and/or core biopsy .During treatment:
· Whenever CR or sCR are suspected
·  Time of PD
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate for MRD (Randomized Part). Fresh bone marrow aspirate should be sent to the central laboratory for MRD assessment. During treatment:
Whenever CR or sCR are suspected:
·  For participants with confirmed CR or sCR, MRD by NGS will be performed at 12, 24, and 36 months post C1D1 (±1 month) until PD or start of SST
At EOT or Follow-up:
·  Until confirmed PD or SST, whichever occurs earlier)
			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.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	If the dose of any agent has been delayed for any reason, contact the provider to ensure all agents are ordered appropriately
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and NOTIFY provider if:
-  ANC LESS than 1,000
-  Platelets LESS than 100,000
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Monitor for neurotoxicity such as somnolence, confusion, hallucinations, blurred vision, and seizures. Notify the provider if any of these symptoms exist.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Montelukast (SINGULAIR) 10 mg once can be added at the discretion of the provider
		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 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				☐	diphenhydrAMINE (BENADRYL) injection 50 mg	Dose: 50 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	If patient cant tolerate oral medications, contact provider to add an IV alternative			Chemotherapy
  	INV-DARATUMUMAB/HYALURONIDASE (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains Daratumumab SC. Administer subcutaneously over 3-5 minutes. No filter required. Stable 12 hours at room temperature or 24 hours refrigerated.			Chemotherapy
  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	Patient will be prescribed lenalidomide 25 mg PO once daily on days 1-21 of each cycle
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 6	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:64007957MMY3005_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***64007957MMY3005*** Treatment: Refer to Section (***6.9 Dose Interruption and Dose Reduction***) Management of AEs. Protocol Access Hyperlink: 64007957MMY3005_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Physical examination. Symptom directed. AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas. Imaging/physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Neurologic examination including ICE Tool
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PRO-CTCAE. Through Cycle 6 unless stopped earlier at the start of SST
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	MRU. Collected continuously from the start of study treatment until 30 days after the last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	TTSP.At time of confirmed PD, document progression-associated symptoms and concomitant medications
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Adverse Events.Continuous until 30 days after last dose or until the start of SST, if earlier; thereafter, continue to report any AEs/SAEs related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Second primary malignancy. Continuous from the time Second primary malignancy of signing of ICF
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Continuous until 30 days after last dose; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	Study visit.If the visit occurs later than planned, adjust subsequent visit(s) accordingly or skip dose per protocol
		  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas.For participants with a history of plasmacytoma:
·  For assessment by physical examination (if applicable) Q4W (±1 week) for the first 2 years from C1D1 and then Q8W (±1 week) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST
·  For assessment by radiology, Q12W (±2 weeks) for the first 2 years from C1D1 and then Q16W (±4 weeks) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST.
As clinically indicated for other participants
		  	ONC NURSING COMMUNICATION 8	Interval: Until discontinued	Occurrences: --	Comments:	When daratumumab SC and talquetamab are to be administered on the same day, daratumumab SC should be administered first.
The following intervals between daratumumab SC and talquetamab should be followed:
-         On Cycle 1 Day 8, talquetamab should be administered >=3 hours after daratumumab SC.
-         Note the requirements for repetition of the required pretreatment medications if >4 hours (steroid) or >6 hours (antihistamine, antipyretic) have elapsed since prior administration of the pretreatment medication (see Table 14)
Thereafter, talquetamab should be administered at least 15 minutes after daratumumab SC
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with differential.
Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	GGT	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	LDH	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Lipase or amylase.Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
Lipase or Amylase
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Lipase or amylase.Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
Lipase or Amylase
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	C1D1, as clinically indicated thereafter. Perform only on participants who are treated with statins
		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	CMV PCR testing is required on D1 of each cycle.
C1D1 is not required if testing is performed during screening.
For participants with no evidence of CMV infection or reactivation in the first 6 cycles, testing requirement will shift to every 3 cycles from C7D1 onward.
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential.
Within 24 hours prior to C1D1, thereafter, Q4W (Q2W for participants with irregular menses) and as clinically indicated. 
4 weeks after the last dose of lenalidomide
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Quantitative immunoglobulins (IgA, IgG, IgM).During treatment:
·  At each disease evaluation for the first 6 months and every third disease evaluation collection thereafter
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	During treatment:
·  If measurable disease by light chain: at each disease evaluation collection
·  Others: whenever CR or sCR are suspected
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	During treatment:
· Whenever CR or sCR are suspected
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate and/or core biopsy .During treatment:
· Whenever CR or sCR are suspected
·  Time of PD
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate for MRD (Randomized Part). Fresh bone marrow aspirate should be sent to the central laboratory for MRD assessment. During treatment:
Whenever CR or sCR are suspected:
·  For participants with confirmed CR or sCR, MRD by NGS will be performed at 12, 24, and 36 months post C1D1 (±1 month) until PD or start of SST
At EOT or Follow-up:
·  Until confirmed PD or SST, whichever occurs earlier)
			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.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	If the dose of any agent has been delayed for any reason, contact the provider to ensure all agents are ordered appropriately
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and NOTIFY provider if:
-  ANC LESS than 1,000
-  Platelets LESS than 100,000
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Monitor for neurotoxicity such as somnolence, confusion, hallucinations, blurred vision, and seizures. Notify the provider if any of these symptoms exist.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Montelukast (SINGULAIR) 10 mg once can be added at the discretion of the provider
		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 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				☐	diphenhydrAMINE (BENADRYL) injection 50 mg	Dose: 50 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	If patient cant tolerate oral medications, contact provider to add an IV alternative			Chemotherapy
  	INV-DARATUMUMAB/HYALURONIDASE (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains Daratumumab SC. Administer subcutaneously over 3-5 minutes. No filter required. Stable 12 hours at room temperature or 24 hours refrigerated.			Chemotherapy
  	INV-TALQUETAMAB 40 MG/ML (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 0.8 mg/kg (Treatment Plan)	Dose: 0.8 mg/kg	Route: subcutaneous	once for 1 dose			Offset: 75 Minutes	Instructions:	Prepared syringe contains talquetamab 40 mg/mL (high concentration). Administer via subcutaneous injection Max 2 mL per syringe. May split injection into multiple syringes. Prepared syringe stable 20 hours at room temp or refrigerated.			Chemotherapy
  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	Patient will be prescribed lenalidomide 25 mg PO once daily on days 1-21 of each cycle
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Physical examination. Symptom directed. AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas. Imaging/physical exam
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Neurologic examination including ICE Tool.C1D2 (applies to Tec-DR and Tal-DR only).
As clinically indicated thereafter
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PRO-CTCAE. Through Cycle 6 unless stopped earlier at the start of SST
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	MRU. Collected continuously from the start of study treatment until 30 days after the last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	TTSP.At time of confirmed PD, document progression-associated symptoms and concomitant medications
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Adverse Events.Continuous until 30 days after last dose or until the start of SST, if earlier; thereafter, continue to report any AEs/SAEs related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Second primary malignancy. Continuous from the time Second primary malignancy of signing of ICF
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Continuous until 30 days after last dose; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	Study visit.If the visit occurs later than planned, adjust subsequent visit(s) accordingly or skip dose per protocol
		  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas.For participants with a history of plasmacytoma:
·  For assessment by physical examination (if applicable) Q4W (±1 week) for the first 2 years from C1D1 and then Q8W (±1 week) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST
·  For assessment by radiology, Q12W (±2 weeks) for the first 2 years from C1D1 and then Q16W (±4 weeks) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST.
As clinically indicated for other participants
		  	ONC NURSING COMMUNICATION 8	Interval: Until discontinued	Occurrences: --	Comments:	When daratumumab SC and talquetamab are to be administered on the same day, daratumumab SC should be administered first.
The following intervals between daratumumab SC and talquetamab should be followed:
-         On Cycle 1 Day 8, talquetamab should be administered >=3 hours after daratumumab SC.
-         Note the requirements for repetition of the required pretreatment medications if >4 hours (steroid) or >6 hours (antihistamine, antipyretic) have elapsed since prior administration of the pretreatment medication (see Table 14)
Thereafter, talquetamab should be administered at least 15 minutes after daratumumab SC
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with differential.
Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	C1D1, as clinically indicated thereafter. Perform only on participants who are treated with statins
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Quantitative immunoglobulins (IgA, IgG, IgM).During treatment:
·  At each disease evaluation for the first 6 months and every third disease evaluation collection thereafter
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate and/or core biopsy .During treatment:
· Whenever CR or sCR are suspected
·  Time of PD
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate for MRD (Randomized Part). Fresh bone marrow aspirate should be sent to the central laboratory for MRD assessment. During treatment:
Whenever CR or sCR are suspected:
·  For participants with confirmed CR or sCR, MRD by NGS will be performed at 12, 24, and 36 months post C1D1 (±1 month) until PD or start of SST
At EOT or Follow-up:
·  Until confirmed PD or SST, whichever occurs earlier)
			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.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	If the dose of any agent has been delayed for any reason, contact the provider to ensure all agents are ordered appropriately
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and NOTIFY provider if:
-  ANC LESS than 1,000
-  Platelets LESS than 100,000
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Monitor for neurotoxicity such as somnolence, confusion, hallucinations, blurred vision, and seizures. Notify the provider if any of these symptoms exist.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	INV-DARATUMUMAB/HYALURONIDASE (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains Daratumumab SC. Administer subcutaneously over 3-5 minutes. No filter required. Stable 12 hours at room temperature or 24 hours refrigerated.			Pre-Medications
☑	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Montelukast (SINGULAIR) 10 mg once can be added at the discretion of the provider
		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 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				☐	diphenhydrAMINE (BENADRYL) injection 50 mg	Dose: 50 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	If patient cant tolerate oral medications, contact provider to add an IV alternative			Chemotherapy
  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	Patient will be prescribed lenalidomide 25 mg PO once daily on days 1-21 of each cycle
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 7	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:64007957MMY3005_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***64007957MMY3005*** Treatment: Refer to Section (***6.9 Dose Interruption and Dose Reduction***) Management of AEs. Protocol Access Hyperlink: 64007957MMY3005_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Physical examination. Symptom directed. AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas. Imaging/physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Neurologic examination including ICE Tool
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PRO-CTCAE. Through Cycle 6 unless stopped earlier at the start of SST
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	MRU. Collected continuously from the start of study treatment until 30 days after the last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	TTSP.At time of confirmed PD, document progression-associated symptoms and concomitant medications
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Adverse Events.Continuous until 30 days after last dose or until the start of SST, if earlier; thereafter, continue to report any AEs/SAEs related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Second primary malignancy. Continuous from the time Second primary malignancy of signing of ICF
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Continuous until 30 days after last dose; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	Study visit.If the visit occurs later than planned, adjust subsequent visit(s) accordingly or skip dose per protocol
		  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas.For participants with a history of plasmacytoma:
·  For assessment by physical examination (if applicable) Q4W (±1 week) for the first 2 years from C1D1 and then Q8W (±1 week) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST
·  For assessment by radiology, Q12W (±2 weeks) for the first 2 years from C1D1 and then Q16W (±4 weeks) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST.
As clinically indicated for other participants
		  	ONC NURSING COMMUNICATION 8	Interval: Until discontinued	Occurrences: --	Comments:	When daratumumab SC and talquetamab are to be administered on the same day, daratumumab SC should be administered first.
The following intervals between daratumumab SC and talquetamab should be followed:
-         On Cycle 1 Day 8, talquetamab should be administered >=3 hours after daratumumab SC.
-         Note the requirements for repetition of the required pretreatment medications if >4 hours (steroid) or >6 hours (antihistamine, antipyretic) have elapsed since prior administration of the pretreatment medication (see Table 14)
Thereafter, talquetamab should be administered at least 15 minutes after daratumumab SC
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Talquetamab (PK and ADA).Predose on the day of dosing. C1D1, C1D15, C4D1, C7D1, C10D1, C13D1, C25D1, EOT, Follow up (8 weeks after last dose).C1D1, C1D15, C4D1, C7D1, C10D1, C13D1, C25D1, EOT, Follow up (8 weeks after last dose). To be collected before administration of daratumumab SC
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Talquetamab (PK and ADA).Suspected Grade GREATER than or EQUAL to 3 sARR. Collect additional PK/immunogenicity sample as soon as Grade >=3 teclistamab- or talquetamab-related sARR is detected, if feasible
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Talquetamab (PK and ADA)
	
	Suspected GREATER than or EQUAL to 3 CRS or Grade GREATER than or EQUAL to 3 neurotoxicity/ICANS.
Collect additional PK/immunogenicity sample as soon as GREATER than or EQUAL to 3 CRS or Grade LESS than or EQUAL to 3 teclistamab- or talquetamab-related neurotoxicity/ICANS is detected, if feasible.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with differential.
Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	GGT	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	LDH	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Lipase or amylase.Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
Lipase or Amylase
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Lipase or amylase.Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration.
Lipase or Amylase
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	C1D1, as clinically indicated thereafter. Perform only on participants who are treated with statins
		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated	Including at CRS onset if applicable
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	CMV PCR testing is required on D1 of each cycle.
C1D1 is not required if testing is performed during screening.
For participants with no evidence of CMV infection or reactivation in the first 6 cycles, testing requirement will shift to every 3 cycles from C7D1 onward.
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Participants of childbearing potential.
Within 24 hours prior to C1D1, thereafter, Q4W (Q2W for participants with irregular menses) and as clinically indicated. 
4 weeks after the last dose of lenalidomide
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Quantitative immunoglobulins (IgA, IgG, IgM).During treatment:
·  At each disease evaluation for the first 6 months and every third disease evaluation collection thereafter
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	During treatment:
·  If measurable disease by light chain: at each disease evaluation collection
·  Others: whenever CR or sCR are suspected
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	During treatment:
· Whenever CR or sCR are suspected
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate and/or core biopsy .During treatment:
· Whenever CR or sCR are suspected
·  Time of PD
At EOT or Follow-up:
Until confirmed PD or SST, whichever occurs earlier)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate for MRD (Randomized Part). Fresh bone marrow aspirate should be sent to the central laboratory for MRD assessment. During treatment:
Whenever CR or sCR are suspected:
·  For participants with confirmed CR or sCR, MRD by NGS will be performed at 12, 24, and 36 months post C1D1 (±1 month) until PD or start of SST
At EOT or Follow-up:
·  Until confirmed PD or SST, whichever occurs earlier)
			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.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	If the dose of any agent has been delayed for any reason, contact the provider to ensure all agents are ordered appropriately
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and NOTIFY provider if:
-  ANC LESS than 1,000
-  Platelets LESS than 100,000
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Monitor for neurotoxicity such as somnolence, confusion, hallucinations, blurred vision, and seizures. Notify the provider if any of these symptoms exist.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Montelukast (SINGULAIR) 10 mg once can be added at the discretion of the provider
		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 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				☐	diphenhydrAMINE (BENADRYL) injection 50 mg	Dose: 50 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	If patient cant tolerate oral medications, contact provider to add an IV alternative			Chemotherapy
  	INV-DARATUMUMAB/HYALURONIDASE (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once over 3-5 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Prepared syringe contains Daratumumab SC. Administer subcutaneously over 3-5 minutes. No filter required. Stable 12 hours at room temperature or 24 hours refrigerated.			Chemotherapy
  	INV-TALQUETAMAB 40 MG/ML (MAJESTEC-7/PRO00041409/GANGULY) SUBCUTANEOUS INJECTION 0.8 mg/kg (Treatment Plan)	Dose: 0.8 mg/kg	Route: subcutaneous	once for 1 dose			Offset: 75 Minutes	Instructions:	Prepared syringe contains talquetamab 40 mg/mL (high concentration). Administer via subcutaneous injection Max 2 mL per syringe. May split injection into multiple syringes. Prepared syringe stable 20 hours at room temp or refrigerated.			Chemotherapy
  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	Patient will be prescribed lenalidomide 25 mg PO once daily on days 1-21 of each cycle
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
End of Treatment (EOT)	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Physical examination. Symptom directed. AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PRO-CTCAE. Through Cycle 6 unless stopped earlier at the start of SST
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas. Imaging/physical exam
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation.
 
On dosing days, vital signs should be performed as follows:
· Daratumumab SC and talquetamab SC: perform before start of administration of each medication.
· Monitor until resolution of CRS or sARR.
Any additional vital signs assessments supporting the start and end dates of an AE (eg, fever or hypotension) should be reported in the eCRF.
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	MRU. Collected continuously from the start of study treatment until 30 days after the last dose or the start of SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	TTSP.At time of confirmed PD, document progression-associated symptoms and concomitant medications
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Adverse Events.Continuous until 30 days after last dose or until the start of SST, if earlier; thereafter, continue to report any AEs/SAEs related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Second primary malignancy. Continuous from the time Second primary malignancy of signing of ICF
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Continuous until 30 days after last dose; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	Study visit.If the visit occurs later than planned, adjust subsequent visit(s) accordingly or skip dose per protocol
		  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas.For participants with a history of plasmacytoma:
·  For assessment by physical examination (if applicable) Q4W (±1 week) for the first 2 years from C1D1 and then Q8W (±1 week) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST
·  For assessment by radiology, Q12W (±2 weeks) for the first 2 years from C1D1 and then Q16W (±4 weeks) until plasmacytoma(s) meet CR criteria or confirmed PD or start of SST.
As clinically indicated for other participants
		  	ONC NURSING COMMUNICATION 8	Interval: Until discontinued	Occurrences: --	Comments:	When daratumumab SC and talquetamab are to be administered on the same day, daratumumab SC should be administered first.
The following intervals between daratumumab SC and talquetamab should be followed:
-         On Cycle 1 Day 8, talquetamab should be administered >=3 hours after daratumumab SC.
-         Note the requirements for repetition of the required pretreatment medications if >4 hours (steroid) or >6 hours (antihistamine, antipyretic) have elapsed since prior administration of the pretreatment medication (see Table 14)
Thereafter, talquetamab should be administered at least 15 minutes after daratumumab SC
			Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Talquetamab (PK and ADA).Predose on the day of dosing. C1D1, C1D15, C4D1, C7D1, C10D1, C13D1, C25D1, EOT, Follow up (8 weeks after last dose).C1D1, C1D15, C4D1, C7D1, C10D1, C13D1, C25D1, EOT, Follow up (8 weeks after last dose). To be collected before administration of daratumumab SC
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Talquetamab (PK and ADA).Suspected Grade GREATER than or EQUAL to 3 sARR. Collect additional PK/immunogenicity sample as soon as Grade >=3 teclistamab- or talquetamab-related sARR is detected, if feasible
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Talquetamab (PK and ADA)
	
	Suspected GREATER than or EQUAL to 3 CRS or Grade GREATER than or EQUAL to 3 neurotoxicity/ICANS.
Collect additional PK/immunogenicity sample as soon as GREATER than or EQUAL to 3 CRS or Grade LESS than or EQUAL to 3 teclistamab- or talquetamab-related neurotoxicity/ICANS is detected, if feasible.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with differential.
Must be performed <=72 hours before dosing.
Note: The laboratory values for C1D1 must meet Section 5.1 criteria. During step-up dosing, laboratory tests must be performed <=24 hours prior to step-up dose administration
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	C1D1, as clinically indicated thereafter. Perform only on participants who are treated with statins
		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --					
Follow up (every 16 Weeks)	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	SST
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Survival.Q16W following confirmed disease progression or the EOT Visit
					
Follow up (every 28 days)	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	SST