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OP RESEARCH PRO00038239 NCT06413498 SCREENING AND RE-SCREENING	

Types:      Research Oncology Treatment
Synonyms:  KT-US-679-0788

Screening	Repeat 1 time	Cycle length: 2 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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:    KT-US-679-0788_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Participants who are unable to complete or meet the eligibility criteria during the 28-day screening period will be permitted to rescreen up to 1 time.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Signed ICF -  LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Demographic data - LESS than or EQUAL to 28 days from ICF signature, Rescreening. For rescreening, re-assess as needed.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Medical history - LESS than or EQUAL to 28 days from ICF signature, Rescreening. For rescreening, re-assess as needed.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	MM disease history - LESS than or EQUAL to 28 days from ICF signature, Rescreening. For rescreening, re-assess as needed.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Previous MM treatment history - LESS than or EQUAL to 28 days from ICF signature, Rescreening. For rescreening, re-assess as needed.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical exam - LESS than or EQUAL to 28 days from ICF signature, Rescreening. Including assessment of EMD.
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening. 
Blood pressure, heart rate, respiration rate, oxygen saturation and temperature.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Neurological examination - LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	ECOG performance status - LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	PROs collection - LESS than or EQUAL to 28 days from ICF signature. 
Prior to any study-specific assessments or procedures, excluding blood draws, and before receipt of any disease status information. PGI-S/PGI-C to be completed after all other PRO measures: EORTC QLQ-C30, EORTC QLQ-MY20, EQ-5D-5L, PGI-S/PGI-C, FACT-GP5.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Collection of AE's and SAE's: 
- Collection of SAEs starts from signing of ICF. 
- Collection of AEs starts from enrollment/randomization. 
- Rescreening.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant medications and procedures - LESS than or EQUAL to 28 days from ICF signature, Re-screening.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature.
			Respiratory Care
  	SPIROMETRY, LUNG VOLUMES, MIPS/MEPS	Interval: --	Occurrences: --	Comments:	Spirometry of forced expiratory volume test. 
LESS than or EQUAL to 28 days from ICF signature. 
Only for participants with known or suspected COPD intended to receive either DPd or KDd.
			Imaging
  	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	Or MUGA. Order as appropriate. 
If the last chemotherapy regimen the participant received is not considered cardiotoxic, an ECHO/MUGA performed as standard of care within 28 days before signing the screening/rescreening ICF may be used for eligibility. 
If the last chemotherapy regimen the participant received is considered cardiotoxic (e.g. carfilzomib), then an ECHO/MUGA performed as standard of care after the participant received their last chemotherapy treatment and within 28 days before signing the screening/rescreening ICF may be used for confirmation of eligibility.
		  	MRI WHOLE BODY WWO	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature. 
Skeletal lesion assessment by whole-body MRI or low-dose whole-body CT or PET-CT with diagnostic CT component. 
Plasmacytoma assessment by PET-CT with diagnostic CT component or MRI or CT scan- Skeletal lesion and plasmacytoma assessment: If imaging was already performed within 28 days before signing the screening ICF as part of standard of care and was performed after the last prior MM therapy, imaging does not need to be repeated during screening
		  	PET CT WHOLE BODY	Interval: --	Occurrences: --	Comments:	Low-dose whole-body CT or PET-CT with diagnostic CT component - LESS than or EQUAL to 28 days from ICF signature.
Skeletal lesion assessment by whole-body MRI or low-dose whole-body CT or PET-CT with diagnostic CT component. 
Plasmacytoma assessment by PET-CT with diagnostic CT component or MRI or CT scan- Skeletal lesion and plasmacytoma assessment: If imaging was already performed within 28 days before signing the screening ICF as part of standard of care and was performed after the last prior MM therapy, imaging does not need to be repeated during screening.
			Procedures
  	BIOPSY BONE MARROW	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate and bone marrow core biopsy, including cytogenetics - LESS than or EQUAL to 28 days from ICF signature, Rescreening. 
If a bone marrow core biopsy was already performed within 42 days before signing the screening/rescreening ICF as part of standard of care, the bone marrow core biopsy does not need to be repeated; however, the bone marrow aspirate collection is still required.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	LACTIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening. 
As clinically indicated.
		  	LDH	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	BUN LEVEL	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Calculate Estimated glomerular filtration rate
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	D-DIMER	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For FCBP
LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	HEPATITIS B CORE ANTIBODY IGM	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	HEPATITIS C VIRUS (HCV) ANTIBODY WITH REFLEX TO PCR	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	HTLV I/II AB WITH REFLEX TO CONFIRMATION	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
If bone marrow aspirate is performed: if a bone marrow core biopsy was already performed within 42 days before signing the screening/rescreening ICF as part of standard of care, the bone marrow core biopsy does not need to be repeated.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
The sponsor should receive a sample of plasmacytoma if a biopsy or FNA is performed for any reason.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	MRD in bone marrow is a mandatory biomarker measurement and will be measured centrally. If central MRD results are not available, then local MRD bone marrow aspirate results are acceptable if the MRD sensitivity threshold of the local laboratory is 10-5 or more.
					
Cycle 2	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days			
Rescreening	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration:    KT-US-679-0788_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Signed ICF -  LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Demographic data - Re-assess as needed.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Medical history - Re-assess as needed
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	MM disease history - Re-assess as needed
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Previous MM treatment history - Re-assess as needed
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical exam - LESS than or EQUAL to 28 days from ICF signature, Rescreening. Including assessment of EMD.
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening. 
Blood pressure, heart rate, respiration rate, oxygen saturation and temperature.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Neurological examination - LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	ECOG performance status - LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Collection of AE's and SAE's: 
- Collection of SAEs starts from signing of ICF. 
- Collection of AEs starts from enrollment/randomization. 
- Rescreening.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant medications and procedures - LESS than or EQUAL to 28 days from ICF signature, Re-screening.
			Imaging
  	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	Or MUGA. Order as appropriate. 
If the last chemotherapy regimen the participant received is not considered cardiotoxic, an ECHO/MUGA performed as standard of care within 28 days before signing the screening/rescreening ICF may be used for eligibility. 
If the last chemotherapy regimen the participant received is considered cardiotoxic (e.g. carfilzomib), then an ECHO/MUGA performed as standard of care after the participant received their last chemotherapy treatment and within 28 days before signing the screening/rescreening ICF may be used for confirmation of eligibility.
			Procedures
  	BIOPSY BONE MARROW	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate and bone marrow core biopsy, including cytogenetics - LESS than or EQUAL to 28 days from ICF signature, Rescreening. 
If a bone marrow core biopsy was already performed within 42 days before signing the screening/rescreening ICF as part of standard of care, the bone marrow core biopsy does not need to be repeated; however, the bone marrow aspirate collection is still required.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	LACTIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening. 
As clinically indicated.
		  	LDH	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	BUN LEVEL	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Calculate Estimated glomerular filtration rate
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	D-DIMER	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days , Rescreening.
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For FCBP
LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	HEPATITIS B CORE ANTIBODY IGM	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	HEPATITIS C VIRUS (HCV) ANTIBODY WITH REFLEX TO PCR	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	HTLV I/II AB WITH REFLEX TO CONFIRMATION	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	LESS than or EQUAL to 28 days from ICF signature, Rescreening.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	If central MRD results are not available, then local MRD bone marrow aspirate results are acceptable if the MRD sensitivity threshold of the local laboratory is 10^-5 or more. MRD by central laboratory is required for all participants regardless of the investigator's IMWG response assessment at the time points specified. In participants who achieve CR or better, MRD is still required to be collected at the specified time points until disease progression or end of study, whichever occurs first. A scheduled MRD time point will not be required if a bone marrow aspirate for central MRD was already performed within the last 3 months of that time point.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	MRD in bone marrow is a mandatory biomarker measurement and will be measured centrally. If central MRD results are not available, then local MRD bone marrow aspirate results are acceptable if the MRD sensitivity threshold of the local laboratory is 10-5 or more.
					
Enrollment/Randomization	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	IXRS/Randomization - Enrollment/ Randomization.
LESS than or EQUAL to 29 days from ICF signature