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OP RESEARCH PRO00038188 NCT06208150 SCREENING	

Types:      Research Oncology Treatment
Synonyms:  

Screening	Repeat 1 time	Cycle length: 28 days	28 Days from Randomization	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:   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 2	Interval: --	Occurrences: --	Comments:	Informed consent to be completed LESS than or EQUAL to 28 days before randomization.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Eligibility criteria
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Demography: to be completed LESS than or EQUAL to 28 days before randomization.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Medical history: Per NCI-CTCAE Version 5.0. 
To be completed LESS than or EQUAL to 28 days before randomization.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior cancer therapies: to be completed LESS than or EQUAL to 28 days before randomization.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Disease characteristics: to be completed LESS than or EQUAL to 28 days before randomization.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status: to be completed LESS than or EQUAL to 28 days before randomization.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Complete physical examination including height, weight. 
To be completed LESS than or EQUAL to 28 days before randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurologic examination including ICE Tool: for participants in Arm A (Tal-P) and Arm B (Tal-Tec) ONLY. 
Ti be completed LESS than or EQUAL to 28 days before randomization.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 days before randomization. 
Performed in the following order: ECG(s), vital signs, blood draw.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse, respiratory rate, blood pressure, and oxygen saturation: to be completed LESS than or EQUAL to 28 days before randomization.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 days before randomization.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events: continuous from the time of signing of ICF.
To be completed LESS than or EQUAL to 28 days before randomization.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Second primary malignancy: continuous from the time of signing of ICF. 
To be completed LESS than or EQUAL to 28 days before randomization.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant therapy: continuous from the time of signing of ICF. 
To be completed LESS than or EQUAL to 28 days before randomization.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Randomization: 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
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 Days before Randomization and 72 hrs prior to first dose of study treatment.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 Days before Randomization and 72 hrs prior to first dose of study treatment.
		  	LDH	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 Days before Randomization and 72 hrs prior to first dose of study treatment.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 Days before Randomization and 72 hrs prior to first dose of study treatment.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 Days before Randomization and 72 hrs prior to first dose of study treatment.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
To be completed LESS than or EQUAL to 28 Days before Randomization and 72 hrs prior to first dose of study treatment.
		  	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.
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 days before randomization.
		  	HIV-1 RNA, QUALITATIVE TMA	Interval: --	Occurrences: --	Comments:	For participants with known HIV if not performed as part of standard of care within 3 months prior to C1D1. 
To be completed LESS than or EQUAL to 28 days before randomization.
		  	CD 4 SUBSET	Interval: --	Occurrences: --	Comments:	For participants with known HIV if not performed as part of standard of care within 3 months prior to C1D1. 
To be completed LESS than or EQUAL to 28 days before randomization.
		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 days before randomization.
		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 days before randomization.
		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 days before randomization.
		  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	HBV-DNA: to be completed LESS than or EQUAL to 28 days before randomization.
		  	HEPATITIS C VIRUS (HCV) ANTIBODY WITH REFLEX TO PCR	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 28 days before randomization. 
If HCV antibody testing was performed as part of standard of care within 3 months prior to C1D1 repeat testing is not required at screening. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing
		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	HCV-RNA: to be completed LESS than or EQUAL to 28 days before randomization. 
If HCV antibody testing was performed as part of standard of care within 3 months prior to C1D1 repeat testing is not required at screening. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Within 10-14 days prior to C1D1 and either serum or urine pregnancy test within 24 h prior to C1D1
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Within 10-14 days prior to C1D1 and either serum or urine pregnancy test within 24 h prior to C1D1
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. In exceptional circumstances, local laboratory assessments may be used to establish measurable disease at screening. 
To be completed LESS than or EQUAL to 28 days before randomization.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. In exceptional circumstances, local laboratory assessments may be used to establish measurable disease at screening. 
To be completed LESS than or EQUAL to 28 days before randomization.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. In exceptional circumstances, local laboratory assessments may be used to establish measurable disease at screening. 
To be completed LESS than or EQUAL to 28 days before randomization.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. In exceptional circumstances, local laboratory assessments may be used to establish measurable disease at screening. 
To be completed LESS than or EQUAL to 28 days before randomization.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. In exceptional circumstances, local laboratory assessments may be used to establish measurable disease at screening. 
If 24-h urine collection (UPEP) begins the day before informed consent is obtained as part of SoC, the sample can be used for this study if it is sent to the central laboratory for analysis after the informed consent was obtained. 
To be completed LESS than or EQUAL to 28 days before randomization.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. In exceptional circumstances, local laboratory assessments may be used to establish measurable disease at screening. 
To be completed LESS than or EQUAL to 28 days before randomization.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. In exceptional circumstances, local laboratory assessments may be used to establish measurable disease at screening. 
To be completed LESS than or EQUAL to 28 days before randomization.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central laboratory. In exceptional circumstances, local laboratory assessments may be used to establish measurable disease at screening. 
To be completed LESS than or EQUAL to 28 days before randomization.
			Imaging
  	BIOPSY BONE MARROW	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate: to be completed LESS than or EQUAL to 28 days before randomization.  
If a biopsy was done within 42d 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.
		  	NM BONE SCAN LIMITED	Interval: --	Occurrences: --	Comments:	Skeletal survey: to be completed LESS than or EQUAL to 28 days before randomization. 
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.
If performed within 42d before randomization, does not need to be repeated at screening
		  	PET CT WHOLE BODY	Interval: --	Occurrences: --	Comments:	Low-dose whole-body CT: to be completed LESS than or EQUAL to 28 days before randomization. 
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.
If performed within 42d before randomization, does not need to be repeated at screening
		  	MRI WHOLE BODY WWO	Interval: --	Occurrences: --	Comments:	Whole-body DWI-MRI: to be completed LESS than or EQUAL to 28 days before randomization. 
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.
If performed within 42d before randomization, does not need to be repeated at screening
				72 Hours before First Dose	Perform every 1 day x1			Research tolerance: -0/+0 days	Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	To be completed 72 hrs prior to first dose of study treatment.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	To be completed 72 hrs prior to first dose of study treatment.
		  	LDH	Interval: --	Occurrences: --	Comments:	To be completed 72 hrs prior to first dose of study treatment.
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	To be completed 72 hrs prior to first dose of study treatment.
		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	To be completed 72 hrs prior to first dose of study treatment.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	IF congenital nonhemolytic hyperbilirubinemia. 
To be completed 72 hrs prior to first dose of study treatment.