Protocol Index	

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OP PRO00038933 EMN30 / SCREENING	

Types:      Research Oncology Treatment
Synonyms:  BASELINE, SCREENING, EMN30

Baseline/Screening( up to 28 days)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Nursing Orders
  	CONSENT OBTAINED	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Eligibility criteria.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Demographics
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Medical History and prior cancer therapies.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Disease characteristics.

See Section 8.1.1.1.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical exam.
Complete examination (See Section 8.3.1).
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs (temperature, pulse/heart rate, respiratory rate, blood pressure) and oxygen saturation
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	See Section 8.3.3.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate.

(see Section 8.2.2)
(Refer to Table 4 and Table 6 for biomarker
sampling at screening. Disease characterization (morphology and either IHC and/or flow cytometry performed locally). Part of the fresh aspirate sample will also be sent to the central laboratory for MRD assessment and/or molecular markers.
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Cytogenetic abnormalities.

Myeloma FISH panel results from the time of diagnosis through screening will be collected in the database.
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Imaging for disease evaluation.

See Section 8.2.4 for acceptable modalities. If performed within 42 days of randomization (C1D1 for participants in SRI1 and SRI2), does not need to be repeated at screening.
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Assessment of soft-tissue plasmacytomas.

See Section 8.2.5 for acceptable modalities and instructions regarding biopsies. If performed within 42 days of randomization (C1D1 for participants in SRI1 and SRI2) does not need to be repeated at screening.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	FIBRINOGEN	Interval: --	Occurrences: --			Labs
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	For women of childbearing potential serum pregnancy testing must be performed within 10-14 days prior to C1D1. Note:
A serum or urine pregnancy test must also be done within 24 hours prior to C1D1 (see Appendix 11).
			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Labs
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Local testing is required if not performed as part of standard of care within 3 months before C1D1.
See Section 8.3.5 for additional information pertinent to HBV and HCV assessment.
		  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	HIV assessment.

Local HIV screening is required if not done as part of standard of care testing prior to transplant.
For participants with known HIV, local HIV testing by PCR and CD4 count are required if not performed as part of
standard of care within 3 months prior to C1D1 (see exclusion criterion #17 [Section 5.2]).
			Labs
  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --		  	HUMAN IMMUNODEFICIENCY VIRUS 1 (HIV-1), QUANTITATIVE PCR	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	· Central laboratory. In extenuating circumstances, local laboratory assessments may be used to establish disease status
at screening (see Section 5.1).
· 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 was sent to the central laboratory for analysis after the informed
consent is obtained.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serum beta 2-microglobulin
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Quantitative immunoglobulins
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	SPEP
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	24-hour UPEP
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serum FLC and SIFE/UIFE
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse event assessment
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Secondary Primary Malignancy
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant Therapy
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Randomization.

Eligible participants must be randomized within 3 days of sponsor approval and must receive C1D1 dose <=7 days after
randomization date. Hematology and Chemistry eligibility criteria must be met again within 3 calendar days prior to first dose (see Table 3, Table 5 and Section 5.1).
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Imaging
  	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	If imaging of complete lung fields has been performed within 42 days of randomization (prior to C1D1 for participants in
SRI1 and SRI2), does not need to be repeated at screening.