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IP/OP RSH PRO00041409 GANGULY MAJESTEC-7 SCREENING	

Types:      Research Oncology Treatment
Synonyms:  PRO00041409, GANGULY, 64007957MMY3005, MAJESTEC-7

Screening (Less than or Equal to 28 days before 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	Interval: Until discontinued	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:64007957MMY3005_Ganguly
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	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:64007957MMY3005_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Informed consent
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Eligibility criteria
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Demography and medical history
		  	ONC NURSING COMMUNICATION 71	Interval: --	Occurrences: --	Comments:	Disease characteristics
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas. Imaging/physical exam
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Physical examination. Complete examination (including height and weight)
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Myeloma Frailty Index
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Neurologic examination including ICE Tool
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Blood type, IAT, and wallet card. Wallet card for study participant identification and results of IAT
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Adverse Events.Continuous from the time Second primary malignancy of signing of ICF
		  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Second primary malignancy. Continuous from the time Second primary malignancy of signing of ICF
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Concomitant therapy.Continuous from the time Second primary malignancy of signing of ICF
		  	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Randomization. Eligible participants must be randomized via IWRS within 3 business days of sponsor approval for randomization and must receive C1D1 dose <=7 calendar days after date of randomization
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Lipase or Amylase
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Lipase or Amylase
		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Monitor creatine kinase only in participants who are treated with statins and receive concurrent treatment with lenalidomide. In these participants, creatine kinase is to be collected at screening, on Cycle 1 Day 1, and as clinically indicated
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	TYPE AND SCREEN	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	FIBRINOGEN	Interval: --	Occurrences: --		  	HUMAN IMMUNODEFICIENCY VIRUS 1 (HIV-1), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Not required at screening if this was performed as part of standard of care within 3 months prior to the start of administration of study treatment
		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --	Comments:	Not required at screening if this was performed as part of standard of care within 3 months prior to the start of administration of study treatment
		  	HEPATITIS B SURFACE AB, QUANTITATIVE	Interval: --	Occurrences: --	Comments:	Not required at screening if this was performed as part of standard of care within 3 months prior to the start of administration of study treatment
		  	TRANSCRIBED HEPATITIS C ANTIBODY	Interval: --	Occurrences: --	Comments:	HCV antibody testing is not required at screening if this was performed as part of standard of care within 3 months prior to the start of administration of study treatment. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing.
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: --	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For participants of childbearing potential
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Participants should rest in a supine position for at least 5 minutes before ECG collection and should refrain from talking or moving arms or legs
		  	SPIROMETRY	Interval: --	Occurrences: --	Comments:	For participants with known or suspected COPD or asthma
		  	PET CT WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging to assess lytic bone lesions
			Procedures
  	BIOPSY BONE MARROW	Interval: --	Occurrences: --	Comments:	Or aspirate. In cases where the morphology or clonality (IHC, IF, or flow cytometry) has been performed within 42 days of randomization, there is no need for repeat testing. Testing for FISH and baseline MRD testing is required.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	In extenuating circumstances and with written approval by the sponsor, local laboratory assessments may be used to establish measurable disease at screening
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	In extenuating circumstances and with written approval by the sponsor, local laboratory assessments may be used to establish measurable disease at screening
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	In extenuating circumstances and with written approval by the sponsor, local laboratory assessments may be used to establish measurable disease at screening
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	In extenuating circumstances and with written approval by the sponsor, local laboratory assessments may be used to establish measurable disease at screening
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	If the 24-hour urine collection (UPEP) begins the day before informed consent is obtained as part of standard of care, the sample can be used for this study as long as it is sent to the central laboratory for analysis after the informed consent was obtained.
In extenuating circumstances and with written approval by the sponsor, local laboratory assessments may be used to establish measurable disease at screening
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	In extenuating circumstances and with written approval by the sponsor, local laboratory assessments may be used to establish measurable disease at screening
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	A portion of the fresh bone marrow aspirate should be obtained and sent to central laboratory for baseline MRD assessment and cytogenetics.