Protocol Index	

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OP RESEARCH PRO00038209 / A062102 GANGULY SCREENING	

Types:      Research Oncology Treatment
Synonyms:  PRE-SCREENING, MULTIPLE MYELOMA, BASELINE

Screening	Repeat 1 time	Cycle length: 28 days	Day -28	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER 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:  A062102_Ganguly
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for IBERDOMIDE Treatment : Refer to Section 8.2 Protocol Access Hyperlink:  A062102_Ganguly
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	History and full physical examination:  <= 28 DAYS before registration:  As clinically indicated for patients assigned to observation.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Pregnancy Prevention Counseling:  <= 28 DAYS before registration:  The Iberdomide Education and Counseling Guidance Document (Appendices VI and VII) for each gender (female and male) must be completed and signed by a trained counselor at the site prior to each dispensing of iberdomide. A copy of this document must be maintained in the subject's records for each dispense. The Iberdomide Information Sheet (Appendix IV) will be given to each patient receiving iberdomide treatment. The patient must read this document prior to starting iberdomide study treatment and each time they receive a new supply of study drug.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	The 42 days within the same build for the <28 days screening
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	To be completed <= 42 DAYS before registration: Any X-ray, scan of any type or ultrasound which is utilized for tumor measurement per protocol.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	To be completed <= 60 DAYS before registration: Any baseline exams used for screening, or any Xray, scan of any type or ultrasound of uninvolved organs which is not utilized for tumor measurement.)
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	CT/MRI/PET-Whole body imaging should be performed within 42 days of cycle 1 day 1.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  <= 28 DAYS before registration:  Pulse, Blood Pressure, Weight As clinically indicated for patients assigned to observation.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Collect archival slides:  Unstained slides from bone marrow core biopsy
			Procedures
☑	PET CT WHOLE BODY	Interval: --	Occurrences: --	Comments:	CT/MRI/PET:  <= 42 DAYS before registration:  Whole body imaging should be performed within 45 days of cycle 1 day 1. Whole body PET-CT is required only for patients with known extramedullary myeloma. All other patients may complete other whole body skeletal imaging, including x-ray skeletal survey, whole-body low-dose CT, or whole-body MRI.
		☑	MRI WHOLE BODY	Interval: --	Occurrences: --	Comments:	EMP Radiological Assessment (only required if history of or clinical indication of EMP):   Whole-body fluorodeoxyglucose positron emission tomography and computed tomography (FDG PET-CT), or whole-body magnetic resonance imaging (MRI), or CT/MRI of involved regions is required.  Imaging performed within 60 days prior to consent is acceptable. See Section 9.1.2.1 for details.
		☑	XR BONE SURVEY SKELETAL	Interval: --	Occurrences: --			Labs
☑	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	Serum protein electrophoresis, serum immunofixation, quantitative immunoglobulins, serum free light chains: <= 28 DAYS before registration:  As clinically indicated for patients assigned to observation.
		☑	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	Serum protein electrophoresis, serum immunofixation, quantitative immunoglobulins, serum free light chains: <= 28 DAYS before registration:  As clinically indicated for patients assigned to observation.
		☑	IMMUNOGLOBULIN G, A, M	Interval: --	Occurrences: --	Comments:	Serum protein electrophoresis, serum immunofixation, quantitative immunoglobulins, serum free light chains: <= 28 DAYS before registration:  As clinically indicated for patients assigned to observation.
		☑	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	24 hour urine protein electrophoresis and immunofixation:  <= 28 DAYS before registration:  As clinically indicated for patients assigned to observation.
		☑	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	24 hour urine protein electrophoresis and immunofixation:  <= 28 DAYS before registration:  As clinically indicated for patients assigned to observation.
		☑	LDH	Interval: --	Occurrences: --	Comments:	<= 28 DAYS before registration
		☑	BETA-2 MICROGLOBULIN	Interval: --	Occurrences: --	Comments:	<= 28 DAYS before registration
		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count (CBC) with differential:  <= 28 DAYS before registration:  As clinically indicated for patients assigned to observation.
		☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete metabolic profile:  <= 28 DAYS before registration:  As clinically indicated for patients assigned to observation. Includes serum creatinine, albumin, glucose, sodium, bicarbonate, calcium, potassium, phosphorus (as clinically indicated), AST, ALT, alkaline phosphatase, total bilirubin
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum HCG:  <= 28 DAYS before registration:  For women of childbearing potential (see Section 3.3). A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy;or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).  Pregnancy tests must occur within 10 - 14 days and again within 24 hours prior to initiation of iberdomide.  FCBP with regular or no menstruation must have a pregnancy test weekly for the first 28 days and then every 28 days while on study treatment (including breaks in treatment); at discontinuation of iberdomide and at day 28 post the last dose of iberdomide. Females with irregular menstruation must have a pregnancy test weekly for the first 28 days and then every 14 days while on study treatment 
(including breaks in treatment), at discontinuation of iberdomide and at Day 14 and Day 28 post the last dose of iberdomide (see Appendix V:Iberdomide Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods).
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Serum
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow biopsy <= 28 DAYS before registration
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate in EDTA tubes for MRD (if patient is in CR/sCR) w/ nursing communication only if patient consents to optional specimen collection and add the specific 1 x 10 ml
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Unstained slides from bone marrow core biopsy
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood in EDTA tubes for immunophenotyping
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood in EDTA tubes for PBMC