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OP RESEARCH PRO00038188 NCT06208150 ARM B	

Types:      Research Oncology Treatment
Synonyms:  

Cycle 1	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	PRO data collection: MySIm-Q, EORTC-QLQC30, EQ-5D-5L, PGI-S, Epstein Taste Survey to be collected on Day 1 of C1 to C12, then on Day 1 of every 3rd cycle.
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	May be performed within 72 hrs before dosing, including for C1D1.
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Patients with history of HBV infection. to be done (±7 days), every 12 weeks (±4 weeks) up to 6 months after last dose
		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Patients with history of HCV antibody positivity. to be done (±7 days), every 12 weeks (±4 weeks) up to 6 months after last dose.
			Labs
  	HIV-1 RNA, QUALITATIVE TMA	Interval: --	Occurrences: --	Comments:	Patients with history of HIV antibody positivity and every 4th cycles thereafter during treatment, and at EOT, 3 and 6 months after last dose
		  	CD 4 SUBSET	Interval: --	Occurrences: --	Comments:	Patients with history of HIV antibody positivity and every 4th cycles thereafter during treatment, and at EOT, 3 and 6 months after last dose.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum pregnancy test within 10-14d prior to C1D1 Serum or urine pregnancy test within 24 h prior to C1D1 and at EOT.
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test within 24 h prior to C1D1 and at EOT.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate.		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate.		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate.			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 10 mcg/kg (Treatment Plan)	Dose: 10 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (0.06-0.3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 10 mg/mL 0.06 mg/kg (Treatment Plan)	Dose: 0.06 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S						Day 4	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate.		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate.		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate.			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Administer Talquetamab GREATER than or EQUAL to 2 days after SU1.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 60 mcg/kg (Treatment Plan)	Dose: 60 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (0.06-0.3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 10 mg/mL 0.3 mg/kg (Treatment Plan)	Dose: 0.3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Administer GREATER than or EQUAL to 2 days after SU1. 
Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S						Day 5	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate.		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate.		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate.			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Administer Talquetamab GREATER than or EQUAL to 2 days after SU1.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 400 mcg/kg (Treatment Plan)	Dose: 400 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 1.5 mg/kg (Treatment Plan)	Dose: 1.5 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Administer GREATER than or EQUAL to 2 days after SU2. 
Administer GREATER than or EUQAL to 2 days after first treatment dose, between Days 7-15. 
Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S						Day 15	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate.		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate.		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate.			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Administer Talquetamab GREATER than or EQUAL to 2 days after first study treatment dose, between Days 7-15.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 1.5 mg/kg (Treatment Plan)	Dose: 1.5 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Administer GREATER than or EQUAL to 2 days after SU2. 
Administer GREATER than or EUQAL to 2 days after first treatment dose, between Days 7-15. 
Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 2	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	PRO data collection: MySIm-Q, EORTC-QLQC30, EQ-5D-5L, PGI-S, Epstein Taste Survey to be collected on Day 1 of C1 to C12, then on Day 1 of every 3rd cycle.
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	May be performed within 72 hrs before dosing.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	C2-C4 talquetamab SC must be administered 14d (±3d) after prior treatment dose.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S						Day 15	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	C2-C4 talquetamab SC must be administered 14d (±3d) after prior treatment dose.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 3	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	PRO data collection: MySIm-Q, EORTC-QLQC30, EQ-5D-5L, PGI-S, Epstein Taste Survey to be collected on Day 1 of C1 to C12, then on Day 1 of every 3rd cycle.
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	C2-C4 talquetamab SC must be administered 14d (±3d) after prior treatment dose.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S						Day 15	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	C2-C4 talquetamab SC must be administered 14d (±3d) after prior treatment dose.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 4	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	PRO data collection: MySIm-Q, EORTC-QLQC30, EQ-5D-5L, PGI-S, Epstein Taste Survey to be collected on Day 1 of C1 to C12, then on Day 1 of every 3rd cycle.
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Patients with history of HBV infection. to be done (±7 days), every 12 weeks (±4 weeks) up to 6 months after last dose
		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Patients with history of HCV antibody positivity. to be done (±7 days), every 12 weeks (±4 weeks) up to 6 months after last dose.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	C2-C4 talquetamab SC must be administered 14d (±3d) after prior treatment dose.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S						Day 15	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	C2-C4 talquetamab SC must be administered 14d (±3d) after prior treatment dose.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 5	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	PRO data collection: MySIm-Q, EORTC-QLQC30, EQ-5D-5L, PGI-S, Epstein Taste Survey to be collected on Day 1 of C1 to C12, then on Day 1 of every 3rd cycle.
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --			Labs
  	HIV-1 RNA, QUALITATIVE TMA	Interval: --	Occurrences: --	Comments:	Patients with history of HIV antibody positivity and every 4th cycles thereafter during treatment, and at EOT, 3 and 6 months after last dose
		  	CD 4 SUBSET	Interval: --	Occurrences: --	Comments:	Patients with history of HIV antibody positivity and every 4th cycles thereafter during treatment, and at EOT, 3 and 6 months after last dose.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	From C5, if confirmed VGPR or better, schedule can change to Q4W dosing (D1 only) per investigator discretion Change to Q4W dosing should occur on C5 or C6 Day 1 (±3d) #At C7 Day 1 (±3d), participants with response of confirmed PR or better must change to Q4W dosing. In exceptional cases only, participants can continue Q2W dosing after sponsor consultation and approval. For all participants who are not in confirmed PR or better at C7D1, continue with Q2W dosing until confirmed PR or better is achieved.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S						Day 15	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	From C5, if confirmed VGPR or better, schedule can change to Q4W dosing (D1 only) per investigator discretion Change to Q4W dosing should occur on C5 or C6 Day 1 (±3d) #At C7 Day 1 (±3d), participants with response of confirmed PR or better must change to Q4W dosing. In exceptional cases only, participants can continue Q2W dosing after sponsor consultation and approval. For all participants who are not in confirmed PR or better at C7D1, continue with Q2W dosing until confirmed PR or better is achieved.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 6	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	PRO data collection: MySIm-Q, EORTC-QLQC30, EQ-5D-5L, PGI-S, Epstein Taste Survey to be collected on Day 1 of C1 to C12, then on Day 1 of every 3rd cycle.
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	From C5, if confirmed VGPR or better, schedule can change to Q4W dosing (D1 only) per investigator discretion Change to Q4W dosing should occur on C5 or C6 Day 1 (±3d) #At C7 Day 1 (±3d), participants with response of confirmed PR or better must change to Q4W dosing. In exceptional cases only, participants can continue Q2W dosing after sponsor consultation and approval. For all participants who are not in confirmed PR or better at C7D1, continue with Q2W dosing until confirmed PR or better is achieved.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S						Day 15	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	From C5, if confirmed VGPR or better, schedule can change to Q4W dosing (D1 only) per investigator discretion Change to Q4W dosing should occur on C5 or C6 Day 1 (±3d) #At C7 Day 1 (±3d), participants with response of confirmed PR or better must change to Q4W dosing. In exceptional cases only, participants can continue Q2W dosing after sponsor consultation and approval. For all participants who are not in confirmed PR or better at C7D1, continue with Q2W dosing until confirmed PR or better is achieved.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 7	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	PRO data collection: MySIm-Q, EORTC-QLQC30, EQ-5D-5L, PGI-S, Epstein Taste Survey to be collected on Day 1 of C1 to C12, then on Day 1 of every 3rd cycle.
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Patients with history of HBV infection. to be done (±7 days), every 12 weeks (±4 weeks) up to 6 months after last dose
		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Patients with history of HCV antibody positivity. to be done (±7 days), every 12 weeks (±4 weeks) up to 6 months after last dose.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	From C5, if confirmed VGPR or better, schedule can change to Q4W dosing (D1 only) per investigator discretion Change to Q4W dosing should occur on C5 or C6 Day 1 (±3d) #At C7 Day 1 (±3d), participants with response of confirmed PR or better must change to Q4W dosing. In exceptional cases only, participants can continue Q2W dosing after sponsor consultation and approval. For all participants who are not in confirmed PR or better at C7D1, continue with Q2W dosing until confirmed PR or better is achieved.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 8	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	PRO data collection: MySIm-Q, EORTC-QLQC30, EQ-5D-5L, PGI-S, Epstein Taste Survey to be collected on Day 1 of C1 to C12, then on Day 1 of every 3rd cycle.
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as Talquetamab suspected reaction, sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	From C5, if confirmed VGPR or better, schedule can change to Q4W dosing (D1 only) per investigator discretion Change to Q4W dosing should occur on C5 or C6 Day 1 (±3d) #At C7 Day 1 (±3d), participants with response of confirmed PR or better must change to Q4W dosing. In exceptional cases only, participants can continue Q2W dosing after sponsor consultation and approval. For all participants who are not in confirmed PR or better at C7D1, continue with Q2W dosing until confirmed PR or better is achieved.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 9	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	PRO data collection: MySIm-Q, EORTC-QLQC30, EQ-5D-5L, PGI-S, Epstein Taste Survey to be collected on Day 1 of C1 to C12, then on Day 1 of every 3rd cycle.
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --			Labs
  	HIV-1 RNA, QUALITATIVE TMA	Interval: --	Occurrences: --	Comments:	Patients with history of HIV antibody positivity and every 4th cycles thereafter during treatment, and at EOT, 3 and 6 months after last dose
		  	CD 4 SUBSET	Interval: --	Occurrences: --	Comments:	Patients with history of HIV antibody positivity and every 4th cycles thereafter during treatment, and at EOT, 3 and 6 months after last dose.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as Talquetamab suspected reaction, sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	From C5, if confirmed VGPR or better, schedule can change to Q4W dosing (D1 only) per investigator discretion Change to Q4W dosing should occur on C5 or C6 Day 1 (±3d) #At C7 Day 1 (±3d), participants with response of confirmed PR or better must change to Q4W dosing. In exceptional cases only, participants can continue Q2W dosing after sponsor consultation and approval. For all participants who are not in confirmed PR or better at C7D1, continue with Q2W dosing until confirmed PR or better is achieved.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 10	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	PRO data collection: MySIm-Q, EORTC-QLQC30, EQ-5D-5L, PGI-S, Epstein Taste Survey to be collected on Day 1 of C1 to C12, then on Day 1 of every 3rd cycle.
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Patients with history of HBV infection. to be done (±7 days), every 12 weeks (±4 weeks) up to 6 months after last dose
		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Patients with history of HCV antibody positivity. to be done (±7 days), every 12 weeks (±4 weeks) up to 6 months after last dose.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as Talquetamab suspected reaction, sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	From C5, if confirmed VGPR or better, schedule can change to Q4W dosing (D1 only) per investigator discretion Change to Q4W dosing should occur on C5 or C6 Day 1 (±3d) #At C7 Day 1 (±3d), participants with response of confirmed PR or better must change to Q4W dosing. In exceptional cases only, participants can continue Q2W dosing after sponsor consultation and approval. For all participants who are not in confirmed PR or better at C7D1, continue with Q2W dosing until confirmed PR or better is achieved.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 11	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	PRO data collection: MySIm-Q, EORTC-QLQC30, EQ-5D-5L, PGI-S, Epstein Taste Survey to be collected on Day 1 of C1 to C12, then on Day 1 of every 3rd cycle.
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as Talquetamab suspected reaction, sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	From C5, if confirmed VGPR or better, schedule can change to Q4W dosing (D1 only) per investigator discretion Change to Q4W dosing should occur on C5 or C6 Day 1 (±3d) #At C7 Day 1 (±3d), participants with response of confirmed PR or better must change to Q4W dosing. In exceptional cases only, participants can continue Q2W dosing after sponsor consultation and approval. For all participants who are not in confirmed PR or better at C7D1, continue with Q2W dosing until confirmed PR or better is achieved.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 12	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	PRO data collection: MySIm-Q, EORTC-QLQC30, EQ-5D-5L, PGI-S, Epstein Taste Survey to be collected on Day 1 of C1 to C12, then on Day 1 of every 3rd cycle.
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	From C5, if confirmed VGPR or better, schedule can change to Q4W dosing (D1 only) per investigator discretion Change to Q4W dosing should occur on C5 or C6 Day 1 (±3d) #At C7 Day 1 (±3d), participants with response of confirmed PR or better must change to Q4W dosing. In exceptional cases only, participants can continue Q2W dosing after sponsor consultation and approval. For all participants who are not in confirmed PR or better at C7D1, continue with Q2W dosing until confirmed PR or better is achieved.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 13	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Qualitative interview: OPTIONAL at 12 months (±3 months) after the start of study treatment.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Patients with history of HBV infection. to be done (±7 days), every 12 weeks (±4 weeks) up to 6 months after last dose
		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Patients with history of HCV antibody positivity. to be done (±7 days), every 12 weeks (±4 weeks) up to 6 months after last dose.
			Labs
  	HIV-1 RNA, QUALITATIVE TMA	Interval: --	Occurrences: --	Comments:	Patients with history of HIV antibody positivity and every 4th cycles thereafter during treatment, and at EOT, 3 and 6 months after last dose
		  	CD 4 SUBSET	Interval: --	Occurrences: --	Comments:	Patients with history of HIV antibody positivity and every 4th cycles thereafter during treatment, and at EOT, 3 and 6 months after last dose.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as Talquetamab suspected reaction, sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	From C5, if confirmed VGPR or better, schedule can change to Q4W dosing (D1 only) per investigator discretion Change to Q4W dosing should occur on C5 or C6 Day 1 (±3d) #At C7 Day 1 (±3d), participants with response of confirmed PR or better must change to Q4W dosing. In exceptional cases only, participants can continue Q2W dosing after sponsor consultation and approval. For all participants who are not in confirmed PR or better at C7D1, continue with Q2W dosing until confirmed PR or better is achieved.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 14	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as Talquetamab suspected reaction, sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	From C5, if confirmed VGPR or better, schedule can change to Q4W dosing (D1 only) per investigator discretion Change to Q4W dosing should occur on C5 or C6 Day 1 (±3d) #At C7 Day 1 (±3d), participants with response of confirmed PR or better must change to Q4W dosing. In exceptional cases only, participants can continue Q2W dosing after sponsor consultation and approval. For all participants who are not in confirmed PR or better at C7D1, continue with Q2W dosing until confirmed PR or better is achieved.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 15	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	PRO data collection: MySIm-Q, EORTC-QLQC30, EQ-5D-5L, PGI-S, Epstein Taste Survey to be collected on Day 1 of C1 to C12, then on Day 1 of every 3rd cycle.
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as Talquetamab suspected reaction, sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	From C5, if confirmed VGPR or better, schedule can change to Q4W dosing (D1 only) per investigator discretion Change to Q4W dosing should occur on C5 or C6 Day 1 (±3d) #At C7 Day 1 (±3d), participants with response of confirmed PR or better must change to Q4W dosing. In exceptional cases only, participants can continue Q2W dosing after sponsor consultation and approval. For all participants who are not in confirmed PR or better at C7D1, continue with Q2W dosing until confirmed PR or better is achieved.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 16	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Patients with history of HBV infection. to be done (±7 days), every 12 weeks (±4 weeks) up to 6 months after last dose
		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Patients with history of HCV antibody positivity. to be done (±7 days), every 12 weeks (±4 weeks) up to 6 months after last dose.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as Talquetamab suspected reaction, sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	From C5, if confirmed VGPR or better, schedule can change to Q4W dosing (D1 only) per investigator discretion Change to Q4W dosing should occur on C5 or C6 Day 1 (±3d) #At C7 Day 1 (±3d), participants with response of confirmed PR or better must change to Q4W dosing. In exceptional cases only, participants can continue Q2W dosing after sponsor consultation and approval. For all participants who are not in confirmed PR or better at C7D1, continue with Q2W dosing until confirmed PR or better is achieved.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 17	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --			Labs
  	HIV-1 RNA, QUALITATIVE TMA	Interval: --	Occurrences: --	Comments:	Patients with history of HIV antibody positivity and every 4th cycles thereafter during treatment, and at EOT, 3 and 6 months after last dose
		  	CD 4 SUBSET	Interval: --	Occurrences: --	Comments:	Patients with history of HIV antibody positivity and every 4th cycles thereafter during treatment, and at EOT, 3 and 6 months after last dose.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as Talquetamab suspected reaction, sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	From C5, if confirmed VGPR or better, schedule can change to Q4W dosing (D1 only) per investigator discretion Change to Q4W dosing should occur on C5 or C6 Day 1 (±3d) #At C7 Day 1 (±3d), participants with response of confirmed PR or better must change to Q4W dosing. In exceptional cases only, participants can continue Q2W dosing after sponsor consultation and approval. For all participants who are not in confirmed PR or better at C7D1, continue with Q2W dosing until confirmed PR or better is achieved.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 18	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	PRO data collection: MySIm-Q, EORTC-QLQC30, EQ-5D-5L, PGI-S, Epstein Taste Survey to be collected on Day 1 of C1 to C12, then on Day 1 of every 3rd cycle.
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	From C5, if confirmed VGPR or better, schedule can change to Q4W dosing (D1 only) per investigator discretion Change to Q4W dosing should occur on C5 or C6 Day 1 (±3d) #At C7 Day 1 (±3d), participants with response of confirmed PR or better must change to Q4W dosing. In exceptional cases only, participants can continue Q2W dosing after sponsor consultation and approval. For all participants who are not in confirmed PR or better at C7D1, continue with Q2W dosing until confirmed PR or better is achieved.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 19	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Patients with history of HBV infection. to be done (±7 days), every 12 weeks (±4 weeks) up to 6 months after last dose
		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Patients with history of HCV antibody positivity. to be done (±7 days), every 12 weeks (±4 weeks) up to 6 months after last dose.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as Talquetamab suspected reaction, sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	From C5, if confirmed VGPR or better, schedule can change to Q4W dosing (D1 only) per investigator discretion Change to Q4W dosing should occur on C5 or C6 Day 1 (±3d) #At C7 Day 1 (±3d), participants with response of confirmed PR or better must change to Q4W dosing. In exceptional cases only, participants can continue Q2W dosing after sponsor consultation and approval. For all participants who are not in confirmed PR or better at C7D1, continue with Q2W dosing until confirmed PR or better is achieved.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 20	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as Talquetamab suspected reaction, sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	From C5, if confirmed VGPR or better, schedule can change to Q4W dosing (D1 only) per investigator discretion Change to Q4W dosing should occur on C5 or C6 Day 1 (±3d) #At C7 Day 1 (±3d), participants with response of confirmed PR or better must change to Q4W dosing. In exceptional cases only, participants can continue Q2W dosing after sponsor consultation and approval. For all participants who are not in confirmed PR or better at C7D1, continue with Q2W dosing until confirmed PR or better is achieved.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 21	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	PRO data collection: MySIm-Q, EORTC-QLQC30, EQ-5D-5L, PGI-S, Epstein Taste Survey to be collected on Day 1 of C1 to C12, then on Day 1 of every 3rd cycle.
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --			Labs
  	HIV-1 RNA, QUALITATIVE TMA	Interval: --	Occurrences: --	Comments:	Patients with history of HIV antibody positivity and every 4th cycles thereafter during treatment, and at EOT, 3 and 6 months after last dose
		  	CD 4 SUBSET	Interval: --	Occurrences: --	Comments:	Patients with history of HIV antibody positivity and every 4th cycles thereafter during treatment, and at EOT, 3 and 6 months after last dose.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as Talquetamab suspected reaction, sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	From C5, if confirmed VGPR or better, schedule can change to Q4W dosing (D1 only) per investigator discretion Change to Q4W dosing should occur on C5 or C6 Day 1 (±3d) #At C7 Day 1 (±3d), participants with response of confirmed PR or better must change to Q4W dosing. In exceptional cases only, participants can continue Q2W dosing after sponsor consultation and approval. For all participants who are not in confirmed PR or better at C7D1, continue with Q2W dosing until confirmed PR or better is achieved.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 22	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Patients with history of HBV infection. to be done (±7 days), every 12 weeks (±4 weeks) up to 6 months after last dose
		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Patients with history of HCV antibody positivity. to be done (±7 days), every 12 weeks (±4 weeks) up to 6 months after last dose.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as Talquetamab suspected reaction, sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	From C5, if confirmed VGPR or better, schedule can change to Q4W dosing (D1 only) per investigator discretion Change to Q4W dosing should occur on C5 or C6 Day 1 (±3d) #At C7 Day 1 (±3d), participants with response of confirmed PR or better must change to Q4W dosing. In exceptional cases only, participants can continue Q2W dosing after sponsor consultation and approval. For all participants who are not in confirmed PR or better at C7D1, continue with Q2W dosing until confirmed PR or better is achieved.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 23	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as Talquetamab suspected reaction, sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	From C5, if confirmed VGPR or better, schedule can change to Q4W dosing (D1 only) per investigator discretion Change to Q4W dosing should occur on C5 or C6 Day 1 (±3d) #At C7 Day 1 (±3d), participants with response of confirmed PR or better must change to Q4W dosing. In exceptional cases only, participants can continue Q2W dosing after sponsor consultation and approval. For all participants who are not in confirmed PR or better at C7D1, continue with Q2W dosing until confirmed PR or better is achieved.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 24	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	PRO data collection: MySIm-Q, EORTC-QLQC30, EQ-5D-5L, PGI-S, Epstein Taste Survey to be collected on Day 1 of C1 to C12, then on Day 1 of every 3rd cycle.
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	From C5, if confirmed VGPR or better, schedule can change to Q4W dosing (D1 only) per investigator discretion Change to Q4W dosing should occur on C5 or C6 Day 1 (±3d) #At C7 Day 1 (±3d), participants with response of confirmed PR or better must change to Q4W dosing. In exceptional cases only, participants can continue Q2W dosing after sponsor consultation and approval. For all participants who are not in confirmed PR or better at C7D1, continue with Q2W dosing until confirmed PR or better is achieved.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
Cycle 25	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical examination: Symptom and disease related. Physical examination to be done once per cycle. Assessment of soft-tissue plasmacytomas by physical examination (if applicable) Q28d (±7d) from C1D1.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination: as clinical indicated.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Venous thromboembolism prophylaxis as clinically indicated 
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --			Labs
  	HIV-1 RNA, QUALITATIVE TMA	Interval: --	Occurrences: --	Comments:	Patients with history of HIV antibody positivity and every 4th cycles thereafter during treatment, and at EOT, 3 and 6 months after last dose
		  	CD 4 SUBSET	Interval: --	Occurrences: --	Comments:	Patients with history of HIV antibody positivity and every 4th cycles thereafter during treatment, and at EOT, 3 and 6 months after last dose.
			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Patients with history of HBV infection. to be done (±7 days), every 12 weeks (±4 weeks) up to 6 months after last dose
		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Patients with history of HCV antibody positivity. to be done (±7 days), every 12 weeks (±4 weeks) up to 6 months after last dose.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect additional PK/immunogenicity sample as soon as Talquetamab suspected reaction, sARR, CRS, or neurotoxicity/ICANS Grade GREATER than or EQUAL to 2 is detected, if feasible.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
			Pre-Medications
  	dexAMETHasone (DECADRON) tablet 20 mg	Dose: 20 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	Administer 1-3 hour (±15 mins) prior to talquetamab SC. If IV is desired, place order as appropriate. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	From C5, if confirmed VGPR or better, schedule can change to Q4W dosing (D1 only) per investigator discretion Change to Q4W dosing should occur on C5 or C6 Day 1 (±3d) #At C7 Day 1 (±3d), participants with response of confirmed PR or better must change to Q4W dosing. In exceptional cases only, participants can continue Q2W dosing after sponsor consultation and approval. For all participants who are not in confirmed PR or better at C7D1, continue with Q2W dosing until confirmed PR or better is achieved.
			Chemotherapy
  	INV-Talquetamab subcutaneous injection (MonumenTAL-6/Pro00036193/Ganguly) 800 mcg/kg (Treatment Plan)	Dose: 800 mcg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active talquetamab.  Administer as a subcutaneous injection.  Doses >1mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Talquetamab injections. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-Teclistamab Subcutaneous injection (1.5-3mg/kg) (MonumenTAL-6/Pro00038188/Ganguly) 90 mg/mL 3 mg/kg (Treatment Plan)	Dose: 3 mg/kg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Prepared syringe(s) contains open label active teclistamab.  Administer as a subcutaneous injection.  Doses >2mL will be split into multiple syringes.  Each syringe injection site should be at least 2cm from other Teclistamab injections, and 10cm from Talquetamab administration site. Stable for 20 hours at room temperature.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S							
EOT (</= 30d after last dose)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	MRU: Collected continuously after first day of study treatment until PD or 30d after last dose or the SST, whichever is earlier.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Symptomatic progression evaluation: From 30d prior, to until 30d after confirmed PD (or the start of SST, whichever is earlier).
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	PRO data collection: MySIm-Q, EORTC-QLQC30, EQ-5D-5L, PGI-S, Epstein Taste Survey
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: From signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinical indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing. Patients on Q4W schedule assessments are not required at Cycle n Day 15 but may be performed as clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LDH	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	From C1D8 may be performed within 48 h before dosing.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
From C1D8 may be performed within 48 h before dosing.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HIV-1 RNA, QUALITATIVE TMA	Interval: --	Occurrences: --	Comments:	Patients with history of HIV antibody positivity and every 4th cycles thereafter during treatment, and at EOT, 3 and 6 months after last dose
		  	CD 4 SUBSET	Interval: --	Occurrences: --	Comments:	Patients with history of HIV antibody positivity and every 4th cycles thereafter during treatment, and at EOT, 3 and 6 months after last dose.
			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Perform PCR testing Q12W (±4 weeks) up to 6 months after last dose of study treatment for participants with history of HBV infection/HCV antibody positivity.
		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Perform PCR testing Q12W (±4 weeks) up to 6 months after last dose of study treatment for participants with history of HBV infection/HCV antibody positivity.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum pregnancy test within 10-14d prior to C1D1 Serum or urine pregnancy test within 24 h prior to C1D1 and at EOT.
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test within 24 h prior to C1D1 and at EOT.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
For participants with measurable disease only by light chain: with every disease evaluation and, if applicable, each pre-PD disease evaluation visit until PD or 30 d after the start of SST. 
Serum FLC
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory . Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. For participants with measurable disease by serum and/or urine M spike: at time of suspected CR or sCR
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: For local assessments; see Section 8.2.6 (a portion of aspirate should be sent to the central laboratory for biomarker and MRD analysis). 
1. Whenever CR or sCR are suspected. 
2. For participants with confirmed CR or sCR, collect additional samples 12 months post C1D1 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, then every 12 months (±3 months) until PD. 
3. Time of PD (even if occurs after treatment is discontinued; should occur prior to SST).
		  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Skeletal survey: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Include imaging of skull, entire vertebral column, pelvis, chest, humeri, femora, and any other anatomical regions for which involvement by disease is suspected.
		  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Low dose whole body CT: As clinically indicated to document response or disease progression before start of SST. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	Whole body DWI-MRI -
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants. 
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
		  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PET/CT with diagnostic CT component - 
1. For lytic bone lesions assessment, perform as clinically indicated to document response or disease progression before start of SST. 
2. For participants with a history of soft-tissue plasmacytoma until development of confirmed CR, PD or start of SST. For assessment by radiology, perform Q12W(±7d) from C1D1. 
3. As clinically indicated for other participants.  
Imaging modality acceptable for disease evaluation and assessment of lytic bone lesions and soft tissue plasmacytoma. 
Should include the vertex of the skull and the knees. If institutional protocols are available, the lower extremities should be shown in full.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pre-dose.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
					
Pre-PD Q28D	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 28 days x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	PRO data collection: MySIm-Q, EORTC-QLQC30, EQ-5D-5L, PGI-S, Epstein Taste Survey to be done every 16 weeks ±14 days during Follow-up Phase' (PRE-PD)
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medications: continuous from signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	SST
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Survival: Every 16 weeks
			Labs
  	HIV-1 RNA, QUALITATIVE TMA	Interval: --	Occurrences: --	Comments:	To be done 3 and 6 months (±1 month) after last dose
		  	CD 4 SUBSET	Interval: --	Occurrences: --	Comments:	To be done 3 and 6 months (±1 month) after last dose
			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Perform PCR testing Q12W (±4 weeks) up to 6 months after last dose of study treatment for participants with history of HBV infection/HCV antibody positivity.
		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Perform PCR testing Q12W (±4 weeks) up to 6 months after last dose of study treatment for participants with history of HBV infection/HCV antibody positivity.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	8 weeks after last dose
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.
					
Post-PD Q16W	Repeat 1 time	Cycle length: 112 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:   MMY3009_Ganguly
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment Drugs: Refer to Section 6.6: 
Protocol Access Hyperlink   MMY3009_Ganguly 
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	PRO data collection: MySIm-Q, EORTC-QLQC30, EQ-5D-5L, PGI-S, Epstein Taste Survey to be done every 16 weeks ±14 days during Follow-up Phase' (PRE-PD)
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: From signing of ICF until 30d 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 33	Interval: --	Occurrences: --	Comments:	SPM: continuous until EOS
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medications: continuous from signing of ICF until 30d after last dose or until the start of SST, if earlier; thereafter, continue to report concomitant therapy given for any AEs/SAEs considered related to study treatment until EOS
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	SST
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Survival: Every 16 weeks
			Labs
  	HIV-1 RNA, QUALITATIVE TMA	Interval: --	Occurrences: --	Comments:	To be done 3 and 6 months (±1 month) after last dose
		  	CD 4 SUBSET	Interval: --	Occurrences: --	Comments:	To be done 3 and 6 months (±1 month) after last dose
			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Perform PCR testing Q12W (±4 weeks) up to 6 months after last dose of study treatment for participants with history of HBV infection/HCV antibody positivity.
		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Perform PCR testing Q12W (±4 weeks) up to 6 months after last dose of study treatment for participants with history of HBV infection/HCV antibody positivity.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	8 weeks after last dose
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based: time of PD
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Response-based - 
1. Time of suspected CR or sCR. 
2. For participants with confirmed CR or sCR, additional samples will be collected 6 (±3 months) and 12 months (±3 months) after time of confirmed CR or sCR, and then every 12 months (±3 months) until PD. 
3. Time of PD.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1. 
SPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. Local laboratory assessments may be used under specified circumstances. Sample may be collected on or within 7 d prior to CnD1.
UPEP assessments will continue until 30 d after the start of the first SST for participants with no PD or unconfirmed PD
			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Biopsy of soft-tissue plasmacytomas as clinically indicated. See section 8.2.5. Order as appropriate.