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OP RESEARCH PRO00035654 NCT04071457 GANGULY PRE REGISTRATION STEP 2	

Types:      Research Oncology Treatment
Synonyms:  SWOG

Cycle 1	Repeat 1 time	Cycle length: 15 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Toxicity Notation
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lenalidomide Education and Counseling
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	PROMIS-29 Profile v2.1.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Intolerance of Uncertainty Scale - Short Form.
		  	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: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Must be collected within 28 days prior to first randomization.
		  	CREATININE LEVEL	Interval: --	Occurrences: --	Comments:	Must be collected within 28 days prior to first randomization.
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	AST (SGOT)	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	ALT (SGPT)	Interval: --	Occurrences: --	Comments:	Must be collected within 42 days prior to first randomization.
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Pregnancy test 24 hours prior to C1D1 should be moved from Step 1 to Step 2 Pre-Registration arm.
			Procedures
  	BIOPSY BONE MARROW	Interval: --	Occurrences: --	Comments:	Or aspirate. Please schedule per unit protocols.
			Labs
  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	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.
		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --	Comments:	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.
		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --	Comments:	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.
		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
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.
		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	o Perform only HMH. Otherwise, perform at Quest or LabCorp. 
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.
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	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.
			Imaging
  	XR BONE SURVEY SKELETAL	Interval: --	Occurrences: --	Comments:	Imaging must be collected within 60 days prior to registration Step 2.
		  	PET CT WHOLE BODY	Interval: --	Occurrences: --	Comments:	o Imaging must be collected within 60 days prior to registration Step 2. 
o Or MRI is appropriate. Please order if needed.
			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Diagnostic BMA Slides for MRD by NGS (Required) 
Archival Diagnostic Bone Marrow Slides. 
Instruction: Submit 3-5 diagnostic bone marrow slides meeting the following requirements:
o Bone marrow aspirate smear or FFPE re-cuts from bone marrow aspirate clot
(bone marrow biopsy core specimens are not accepted)
o Unstained slides without cover slips preferred*
o Ensure slide is labeled with the SWOG Patient ID. 
o Ship in slide box labeled with SWOG Patient ID. 
o Ensure slides are packed to avoid breakage during shipping. 
o Ship overnight at ambient temperature, 10 AM PT delivery. 
* Slides that include cover slips require additional processing time and may result in delayed result reporting. Ship with fresh Bone Marrow Aspirate at 1st Randomization Specimen Labeling, Packaging, and Shipping.
Specimens must be labeled with the following information:
o Protocol number (S1803). 
o SWOG patient ID. 
o Specimen ID as generated by the SWOG Specimen Tracking System (note each specimen should have a unique specimen ID).
o Sites NCI code. 
o Date and time of specimen collection.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone Marrow Aspirate (from first draw).  
Required (collect prior to Registration Step 2). 
Instructions: Overnight shipping required Lab# 233. 
For Reg Step 2 time point: Ship with diagnostic bone marrow aspirate slides. 
Instructions: Collect 2ml anticoagulated bone marrow aspirate in EDTA (lavender top) tube from the first draw at the time points listed (Note: only bone marrow aspirate may be used for the assay; blood may not be submitted in place of marrow. 
Collection Timepoint: Prior to Registration Step 2 (post transplant). 
Specimen Labeling, Packaging, and Shipping. 
Specimens must be labeled with the following information:
o Protocol number (S1803). 
o SWOG patient ID. 
o Specimen ID as generated by the SWOG Specimen Tracking System (note each specimen should have a unique specimen ID). 
o Sites NCI code. 
o Date and time of specimen collection.
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone Marrow Aspirate for Banking.
Bone Marrow Aspirate (from first draw) Overnight shipping required Lab# 201. Refer to: Please collect 10-20 mL bone marrow aspirate in sodium heparin (green top) tubes or (if dry tap) 60 mL peripheral blood heparin (green top) tubes
https://www.swog.org/memberresources/biospecimenresources