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OP RESEARCH PRO00036193 MMY3002 SCREENING GANGULY 	

Types:      Research Oncology Treatment
Synonyms:  NCT05455320 

Cycle 1	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Informed consent: Comprehension survey to be completed by participants enrolled in the ICF substudy (Appendix 21). To be completed LESS than or EQUAL to 28d before randomization.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Eligibility criteria: Eligible participants must be randomized within 3 days of sponsor approval for randomization and must receive C1D1 dose LESS than or EQUAL to 7 days after date randomized. Hematology and Chemistry eligibility criteria must be met again within 72 hours prior to first dose.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Demography to be completed LESS than or EQUAL to 28d before randomization.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Medical history and prior cancer therapies to be completed LESS than or EQUAL to 28d before randomization. Grade per NCI-CTCAE Version 5.0.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Disease characteristics (tumor type and histology); date of diagnosis; cancer stage; available pathology and molecular data; prior antimyeloma therapies, and date of most recent disease progression. To be completed LESS than or EQUAL to 28d before randomization .
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG performance status to be completed LESS than or EQUAL to 28d before randomization.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Complete Physical Exam to be completed LESS than or EQUAL to 28d before randomization.
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28d before randomization.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Neurologic examination including ICE Tool to be completed LESS than or EQUAL to 28d before randomization. See Section 8.3.7 and Appendix 16.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Including OXYGEN SATURATION. To be completed LESS than or EQUAL to 28d before randomization.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28d before randomization.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Spirometry test: For participants with known or suspected COPD or asthma. To be LESS than or EQUAL to 28 Days before Randomization if needed.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Events to be completed LESS than or EQUAL to 28 days before randomization.  Continuous from the time of signing of ICF.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Second primary malignancy to be completed LESS than or EQUAL to 28 Days before Randomization.  Continuous from the time of signing of ICF.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant therapy to be completed LESS than or EQUAL to 28 Days before Randomization. Continuous from the time of signing of ICF.
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Randomization: Eligible participants must be randomized within 3 days of sponsor approval for randomization and must receive C1D1 dose to be completed LESS than or EQUAL to 7 days after date.
			Labs
  	TYPE AND SCREEN	Interval: --	Occurrences: --	Comments:	Test includes ABO and Rh type, Indirect Coombs'. To be completed LESS than or EQUAL to 28 days before randomization.
			Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Wallet card
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 days before randomization.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 days before randomization.
		  	GGT	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 days before randomization.
		  	LDH	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 days before randomization.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 days before randomization.
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	o To be completed LESS than or EQUAL to 28 days before randomization.  
o Standard eGFR includes Creatinine and Cystatin C at HM.
		  	HUMAN IMMUNODEFICIENCY VIRUS 1 (HIV-1), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	For participants with known HIV, local HIV testing by PCR and CD4 count are required if not performed as part of standard of care within 3 months prior to C1D1 (see inclusion criteria #8 [Section 5.1].
		  	CD 4 SUBSET	Interval: --	Occurrences: --	Comments:	For participants with known HIV, local HIV testing by PCR and CD4 count are required if not performed as part of standard of care within 3 months prior to C1D1 (see inclusion criteria #8 [Section 5.1].
		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --	Comments:	o To be completed LESS than or EQUAL to 28 Days before Randomization. 
o Not required at screening if this was performed as part of standard of care within 3 months prior to C1D1.
		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --	Comments:	o To be completed LESS than or EQUAL to 28 Days before Randomization. 
o Not required at screening if this was performed as part of standard of care within 3 months prior to C1D1.
		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --	Comments:	o To be completed LESS than or EQUAL to 28 Days before Randomization. 
o Not required at screening if this was performed as part of standard of care within 3 months prior to C1D1.
		  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	o To be completed LESS than or EQUAL to 28 Days before Randomization ONLY IF NEEDED.
o Not required at screening if this was performed as part of standard of care within 3 months prior to C1D1.
		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	o To be completed LESS than or EQUAL to 28 Days before Randomization ONLY IF NEEDED anti-HCV positive. 
o Local testing is required if not performed as part of standard of care within 3 months before C1D1.
		  	HEPATITIS C ANTIBODY	Interval: --	Occurrences: --	Comments:	o To be completed LESS than or EQUAL to 28 Days before Randomization. 
o Local testing is required if not performed as part of standard of care within 3 months before C1D1.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 Days before Randomization.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 Days before Randomization.
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child bearing age. To be completed LESS than or EQUAL to 28 Days before Randomization. Order urine pregnancy test if appropriate.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 days before randomization. In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 days before randomization. In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 days before randomization. In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 days before randomization. In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 days before randomization. In extenuating situations, local laboratory assessments may be used to establish measurable disease at screening.
			Procedures
  	BIOPSY BONE MARROW	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate to be completed LESS than of EQUAL to 28 days before randomization. 
If a biopsy was done within 42 days before randomization, no need to repeat for morphology; however, fresh aspirate samples need to be obtained and sent to central laboratory for MRD, cytogenetics, immunophenotype and molecular markers.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Assessment of bone lesions and soft tissue plasmacytomas: 
1. Any of the following imaging methods are acceptable (except where specified Section 8.2.4 and 8.2.5: skeletal survey (only to assess bone lesions), whole-body MRI, low-dose whole-body CT or PET/CT with diagnostic CT component. 
2. To be completed LESS than or EQUAL to 28 days before randomization. 
3. IF performed within 42 days before randomization, does not need to be repeated at screening. Order appropriate test if needed.