Protocol Index	

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OP RESEARCH PRO00035654 NCT04071457 GANGULY PRE REGISTRATION STEP 1	

Types:      Research Oncology Treatment
Synonyms:  SWOG

Cycle 1	Repeat 1 time	Cycle length: 15 days	Day 1	Perform every 1 day x1		Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test 14 days prior to registration
				Day 15	Perform every 1 day x1		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: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  S1803_Protocol.pdf.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for S1803 Treatment : : Refer to Management of AEs Associated with STUDY DRUGS in Protocol. Protocol Access Hyperlink: S1803_Protocol.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	History and Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Weight and Performance Status
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	The following items should be collected as standard of care to confirm subject eligibility, and should NOT be collected or re-collected for research purposes until step 2. If still needed, please place orders manually.
o   Serum Electrophoresis (SPEP); 
o   Serum quantitative immunoglobulins; 
o   24-hr Urine Protein electrophoresis (UPEP); 
o   Serum Free light chains; 
o   Bone marrow aspirate/biopsy; 
o   Cytogenetics; 
o   FISH.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Procedures
  	BIOPSY BONE MARROW	Interval: --	Occurrences: --	Comments:	o Bone Marrow Aspirate/Biopsy. Please schedule per unit protocol. 
o Pre-Registration Step 1 bone marrow, FISH, cytogenetics and multiple myeloma response assessments are all to be from diagnosis, and do not need to be collected prior to registration Step 1.
			Labs
  	CREATININE LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --			Labs
  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE AB, QUANTITATIVE	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY IGM	Interval: --	Occurrences: --		  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	HCV is not required and completed only as clinical indicated
			Nursing Orders
  	SPIROMETRY PRE AND POST WITH BRONCHILATOR	Interval: --	Occurrences: --	Comments:	o Spirometry DLCO, FEV, FEV1, FVC. 
o Before registration to Step 1: Required for determination of transplant eligibility; see Section 5.1o; for patients who are registered after transplant, tests
need not be repeated.
		  	BODY PLETHYSMOGRAPHIC LUNG VOLUMES	Interval: --	Occurrences: --	Comments:	o Spirometry DLCO, FEV, FEV1, FVC. 
o Before registration to Step 1: Required for determination of transplant eligibility; see Section 5.1o; for patients who are registered after transplant, tests
need not be repeated.
		  	DIFFUSION CAPACITY	Interval: --	Occurrences: --	Comments:	o Spirometry DLCO, FEV, FEV1, FVC. 
o Before registration to Step 1: Required for determination of transplant eligibility; see Section 5.1o; for patients who are registered after transplant, tests
need not be repeated.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	The following items should be collected as standard of care to confirm subject eligibility, and should NOT be collected or re-collected for research purposes until step 2. If still needed, please place orders manually.
o   Serum Electrophoresis (SPEP); 
o   Serum quantitative immunoglobulins; 
o   24-hr Urine Protein electrophoresis (UPEP); 
o   Serum Free light chains; 
o   Bone marrow aspirate/biopsy; 
o   Cytogenetics; 
o   FISH.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females of childbearing potential must have negative pregnancy test 14 days prior to registration and again within 24 hours prior to starting treatment on
Cycle 1, Day 1.