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OP RSH PRO00045934 R5458-HM-24145 GANGULY SCREENING	

Types:      Research Oncology Treatment
Synonyms:  PRO00045934 R5458-HM-24145

Baseline/Screening	Repeat 1 time	Cycle length: 28 days	Baseline/Screening	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   [AR1] 
R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for LINVOSELTAMAB Treatment: Refer to Section 6.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for DARATUMUMAB Treatment: Refer to Section 6.6.46.6.1Protocol Access Hyperlink:  R5458-HM-24145_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Main informed consent. Informed consent must be obtained before any study-related procedures are performed. See Appendix 1 (Section 10.1.3).
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Informed consent for optional FBR sub-study. Informed consent for optional FBR sub-study will be required for participants who choose to participate in the sub-study.
Consent can occur any time during screening but must be obtained before samples are stored for FBR. See Appendix 1 (Section 10.1.3).
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Informed consent for optional genomics sub-study. Informed consent for optional genomics sub-study will be required for participants who choose to participate in the
sub-study. Consent can occur any time during screening but must be obtained before samples are collected
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Inclusion/exclusion criteria. See Section 5.1 and Section 5.2. Participants must continue to meet all eligibility criteria until C1D1.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Medical/oncology history. See Section 8.4.1
		  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	Demographics
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Complete physical examination. See Section 8.1.1 and Section 8.3.1
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Randomization. Randomization should occur only after informed consent and all eligibility criteria are met, including testing results.
Participants should begin the assigned treatment within 3 days of randomization.
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Echo or MUGA.Do not need to be repeated if they have been performed within 8 weeks (56 days) prior to randomization
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	ECOG status. See Section 8.3.7.
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Adverse events. See Section 8.4.
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Concomitant medication. Section 6.9.2.
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Concomitant procedure. Section 6.9.2.
		  	ECG 12-LEAD	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30. All PRO questionnaires will be administered and completed by the participant during the visit prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC
IL478, EQ-5D-5L, FACIT Item GP5. See Section 8.11.
		  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	EORTC IL478. All PRO questionnaires will be administered and completed by the participant during the visit prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC
IL478, EQ-5D-5L, FACIT Item GP5. See Section 8.11.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. All PRO questionnaires will be administered and completed by the participant during the visit prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC
IL478, EQ-5D-5L, FACIT Item GP5. See Section 8.11.
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	FACIT Item GP5.All PRO questionnaires will be administered and completed by the participant during the visit prior to any other study procedures. Where applicable, the questionnaires will be administered in the following order: EORTC QLQ-C30, EORTC IL478, EQ-5D-5L, FACIT Item GP5. See Section 8.11.
		  	HEIGHT AND WEIGHT	Interval: Once	Occurrences: --	Comments:	Height - Only at screening. See Section 8.3.1.1
Weight - See Section 8.3.1.2.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs (temperature, heart rate, BP, RR, and O2 saturation), will be collected predose at study visits according to the SoA (Section 1.3). When scheduled at the same time as other procedures, vital signs should be measured prior to blood collection. Blood pressure and heart
rate should be measured after the participant has been resting quietly for at least 5 minutes.
Blood pressure may be obtained from a seated or recumbent position and should be done consistently throughout the study.. See Section 8.3.2.
			Imaging
☑	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Whole body imaging (MRI, FDG PET/CT, low-dose CT. First perform whole-body PET/CT or low-dose CT. If CT is negative, whole-body MRI must be performed to exclude focal lesions; see Section 8.2.2. No need to repeat imaging method if performed within 8 weeks (56 days) prior to randomization.
		☐	PET CT WHOLE BODY	Interval: --	Occurrences: --		☐	MRI WHOLE BODY	Interval: --	Occurrences: --			Labs
  	BETA-2 MICROGLOBULIN	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --	Comments:	HBV testing should include HBsAg and HBcAb. HCV RNA testing is required only if hepatitis C antibody is positive.
See exclusion criterion #14 and Appendix 2 (Section 10.2).
		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --	Comments:	HBV testing should include HBsAg and HBcAb. HCV RNA testing is required only if hepatitis C antibody is positive.
See exclusion criterion #14 and Appendix 2 (Section 10.2).
		  	HEPATITIS C VIRUS (HCV) RNA, DIAGNOSIS	Interval: --	Occurrences: --	Comments:	HBV testing should include HBsAg and HBcAb. HCV RNA testing is required only if hepatitis C antibody is positive.
See exclusion criterion #14 and Appendix 2 (Section 10.2).
		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --	Comments:	HBV testing should include HBsAg and HBcAb. HCV RNA testing is required only if hepatitis C antibody is positive.
See exclusion criterion #14 and Appendix 2 (Section 10.2).
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Hematology and blood chemistry must be repeated if collected >3 days before randomization. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Hematology and blood chemistry must be repeated if collected >3 days before randomization. See Section 8.3.4 and Appendix 2 (Section 10.2).
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		  	CD 4/8 SUBSET	Interval: --	Occurrences: --		  	BCM MM FISH PANEL	Interval: --	Occurrences: --	Comments:	BM aspirate for risk classification.FISH testing should be done locally and must include probes for t(4;14), t(14;16), amp/gain(1q), del(13q)/monosomy 13, and del(17p). A sample for central testing should be submitted if adequate local testing is not available.TP53 mutation status assessed using an NGS-based method should be reported, if available.
			Labs
◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Pregnancy (serum or urine).For women of child-bearing potential.A serum ß-hCG must be obtained at screening. After screening, subsequent tests may be performed on urine. See Section 8.3.5.
		◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Pregnancy (serum or urine).For women of child-bearing potential.A serum ß-hCG must be obtained at screening. After screening, subsequent tests may be performed on urine. See Section 8.3.5.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	24-hour urine for UPEP and UIFE.See Section 8.2.1.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Total protein (urine). See Section 8.2.1. Samples should be taken before PET/CT to avoid presence of potential 18F radioactive tracer in the biological specimens sent to central laboratory.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	SPEP and SIFE. See Section 8.2.1. Samples should be taken before PET/CT to avoid presence of potential 18F radioactive tracer in the biological specimens sent to central laboratory.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Total protein (serum). See Section 8.2.1. Samples should be taken before PET/CT to avoid presence of potential 18F radioactive tracer in the biological specimens sent to central laboratory.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Immunoglobulin quantification Immunoglobulin quantification (IgA, IgM, IgG, IgD or IgE). See Section 8.2.1. Samples should be taken before PET/CT to avoid presence of potential 18F radioactive tracer in the biological specimens sent to central laboratory.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Serum FLC. See Section 8.2.1. Samples should be taken before PET/CT to avoid presence of potential 18F radioactive tracer in the
biological specimens sent to central laboratory.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	BM aspirate and core biopsy. A core biopsy performed within 8 weeks (56 days) from randomization should be submitted to the central laboratory as archival tissue. If archival tissue is not available, a fresh core biopsy is required. See Section 8.2.4.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	BM aspirate for MRD. A BM aspirate at screening is required to identify the dominant clonal sequence for assessment of MRD after initiation of treatment. See Section 8.2.4.