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OP RSH PRO00036001 / CA057-008 SCREENING	

Types:      Research Oncology Treatment
Synonyms:  SCREENING, BASELINE, RRMM, RELAPSED, MYELOMA, CA057-008, PRO00036001

Baseline/Screening( up to 28 days and then Randomization)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 0 days x1		Nursing Orders
  	CONSENT OBTAINED	Interval: --	Occurrences: --	Comments:	A participant is considered enrolled only when a protocol-specific informed consent is signed. Must be obtained prior to performing any screening procedures.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Inclusion/exclusion criteria.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Demographics and Medical History. 
All relevant medical conditions diagnosed/occurring prior to screening and history of toxicities related to prior treatments and allergies.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	IRT Assignment.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/ Concomitant
Medication and Procedure
Evaluation
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Second Primary Malignancy (SPM) Surveillance. 
Continuous, starting after informed consent signature, until the end of study.All SPMs must be reported as Serious Adverse Events (SAEs);monitoring continues until end of study.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Extramedullary Plasmacytoma (EMP) Radiological Assessment (only required if history or clinical indication of EMPs).

Assessments done within 14 days prior to screening are acceptable. If a CT or MRI was performed within 14 days of screening as standard of care, it will not need to be repeated and can be used for screening assessment. Positron emission tomography (PET) scan or ultrasound tests are not acceptable to document the size of extramedullary plasmacytomas. If PET/CT is performed, the measurements should be taken from the CT portion of the imaging. Ensure the same modality (eg., CT or MRI) will be used for all assessments for a given participant.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EMP Clinical Assessment (for participants with skin involvement of EMPs).

For participants with skin involvement of extramedullary plasmacytomas, skin lesions should be assessed by physical examination and measured with a ruler.
			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Biomarkers Assessments/Pharmacogenomics
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Health-Related Quality of Life: EORTC QLQ-C30, EORTC QLQ-MY20 (participants randomized to Stage 2 only).
Within 4 weeks prior to Cycle 1 Day 1.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Physical exam to include general appearance, skin, lung, heart, abdomen, assessment for venous thromboembolic events (ex swelling, calf  pain, shortness of breath), and neurological assessment.  A full physical examination, including venous thromboembolic assessment should be conducted at screening and at C1D1.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate and respiratory rate.
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Thromboembolism prophylaxis
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Antiviral Prophylaxis
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	-  ECGs should be recorded after the participant has been supine for at least 5 minutes. 
-  A single ECG recording is adequate.  
-  Tests are performed and reviewed locally.
-  For Day 1, 8, and 15 of all cycles, perform as clinically indicated.
			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --	Comments:	Or MUGA; For Day 1, 8, and 15 of all cycles, perform as clinically indicated.
		  	ZZ_HIST_NM CARDIAC BLOOD POOL MUGA (AT REST)	Interval: --	Occurrences: --	Comments:	Or ECHO; For Day 1, 8, and 15 of all cycles, perform as clinically indicated.
			Labs
  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --		  	HEPATITIS C ANTIBODY	Interval: --	Occurrences: --		  	HEPATITIS B VIRUS DNA, QUANTITATIVE, REAL-TIME PCR (WITH LABCORP SERIAL MONITORING)	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --			Labs
  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --			Labs
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	For Hematology and Chemistry labs, Investigators have the option to use local or central laboratories, especially on dosing days.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	ALBUMIN LEVEL	Interval: --	Occurrences: --		  	PROTEIN, TOTAL	Interval: --	Occurrences: --		  	ALKALINE PHOSPHATASE	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	CALCIUM LEVEL	Interval: --	Occurrences: --		  	IONIZED CALCIUM	Interval: Once	Occurrences: --		  	CHLORIDE LEVEL	Interval: --	Occurrences: --		  	POTASSIUM LEVEL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	GLUCOSE LEVEL	Interval: --	Occurrences: --		  	LACTATE DEHYDROGENASE (LDH)	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	SODIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --	Comments:	also measure direct and indirect bilirubinif total bilirubin is Grade > 1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	BUN LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	CO2 LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	GLOMERULAR FILTRATION RATE, ESTIMATED (EGFR)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Pregnancy counseling
-  Must be completed -10 to -14 days prior to C1D1.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --			Labs
  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --			Labs
  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --		  	KAPPA LIGHT CHAIN, FREE, SERUM	Interval: --	Occurrences: --		  	LAMBDA LIGHT CHAIN, FREE, SERUM	Interval: --	Occurrences: --			Labs
  	BETA-2 MICROGLOBULIN	Interval: --	Occurrences: --	Comments:	Samples must be sent to central lab for analysis.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bone Lesion Assessment .
-  Within 60 days prior to randomization is acceptable.
-  Skeletal survey is done locally and can be performed by MRI or CT or X-ray provided the same modality will be used for future assessments.
-  If PET/CT is performed, the location and number of skeletal lesions should be taken from the CT portion of the imaging.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate (BMA) sampling for cytogenetics (FISH), % plasma cells, MRD assessment, and biomarkers.  Do not repeat for patients who re-screen within 6 months of prior screening and have not received any new anti-cancer therapy.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow biopsy (BMB) sampling for IHC, % plasma cells,and biomarkers.  Bone marrow aspirate clot can be provided if biopsy cannot be obtained.