Protocol Index	

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OP RESEARCH PRO00037922 / GANGULY PFIZER C1071032 OPEN-LABEL SCREENING	

Types:      Research Oncology Treatment
Synonyms:  ELREXFIO, EMPLICITI, POMALYST, IMNOVID, VELCADE, KYPROLIS, ANTI-CD38, MAGNETISMM-32

Day -28	Repeat 1 time	Cycle length: 28 days	Day -28	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Informed Consent
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Distribute Emergency Contact Card
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Distribute Infection Reminder Card
-  Infection Reminder Card can be distributed on C1D1 prior to dose administration.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Eligibility Criteria
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	IRT Registration
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Demography / medical history / surgical history
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Disease characteristics / treatment history
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	COVID-19 vaccine history
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Contraception check
-  Study staff will confirm that the participant is using an appropriate method of contraception for the individual participant (and their partner(s), as applicable) from the permitted list of contraception methods.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical Exam
-  Include general appearance, head, skin, neck, eyes, ears, nose, throat, mouth, lungs, heart, abdomen, lymph nodes, extremities, musculoskeletal.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Neurological Exam
-  Assessment of mental state, motor function, sensory function, gait, deep tendon reflexes, cranial nerve function, station, and coordination will be performed.
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Patient Reported Outcomes: EORTC QLQ-C30, MY20, EQ-5D-5L and WPAI.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Concomitant medications - continuously
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Serious and nonserious Adverse Event monitoring - continuously
		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, HR, BP, and O2 saturation.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Standard 12-lead ECGs utilizing limb leads (with a 10 second rhythm strip).
			Labs
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	The following labs to be performed by central laboratory:
-  SPEP, SIFE, FLC, UPEP, UIFE
-  Serum quantitative immunoglobulins (IgG, IgM, IgA, IgD, IgE).
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	-  To be performed within 10 to 14 days prior to C1D1.  
-  For female participants of childbearing potential only.
			Labs
  	ONC NURSING COMMUNICATION 107	Interval: --	Occurrences: --	Comments:	The following lab to be performed by central laboratory:  Serum Beta-2 microglobulin.
			Labs
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	The following labs to be performed by central laboratory:
Hematology
			Labs
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	The following labs to be performed by central laboratory:
Chemistry - Albumin, Alkaline phosphatase, AST, ALT, Chloride, Creatinine, Glucose (non-fasting), LDH, Magnesium, Phosphorus or Phosphate, Potassium, Sodium, Total bilirubin, Total Calcium, Urea or BUN, Uric acid.
			Labs
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	The following labs to be performed by central laboratory:
Coagulation - PT/INR
			Labs
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	The following labs to be performed by central laboratory:
Thyroid - TSH and reflex testing (T3 and free T4)
- See Lab Manual, Appendix 2.
			Labs
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	SARS-CoV-2 testing
-  PCR test required at screening within 5 days before randomization assessed by local laboratory. 
-  PCR or antigen test required predose on Day 1 of every cycle and upon suspected exposure to COVID-19 and at signs or symptoms of COVID19 infection.
			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	See Lab Manual Appendix 2, Appendix 18.
		  	CYTOMEGALOVIRUS BY PCR	Interval: --	Occurrences: --	Comments:	-  To be done prior to administration of first treatment on study (at screening or C1D1) and then every 1 to 3 cycles depending on risk factors and baseline CMV viral load as clinically indicated. 
-  See Section 6.9.2, Appendix 2, Appendix 17.
		  	EPSTEIN-BARR VIRUS (EBV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	-  On-study testing should be performed on a monthly to every three-month schedule depending on risk factors and baseline EBV viral load and as clinically indicated. 
-  Section 6.9.2, Appendix 2, Appendix 17.
		  	ADENOVIRUS BY PCR	Interval: --	Occurrences: --	Comments:	-  On-study testing should be performed on a monthly to every three-month schedule depending on risk factors and baseline EBV viral load and as clinically indicated. 
-  Section 6.9.2, Appendix 2, Appendix 17.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Imaging
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	PET/CT, CT or MRI - At screening (SOC imaging within 42 days prior to C1D1 can be used to meet screening requirement).
			Cardiology
  	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	Or MUGA
		  	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	Or Echo
				Day -7	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Concomitant medications - continuously
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Serious and nonserious Adverse Event monitoring - continuously
			Labs
  	RESPIRATORY PATHOGEN PANEL WITH COVID-19 RT-PCR	Interval: --	Occurrences: --	Comments:	-  Required at screening within 5 days before randomization assessed by local laboratory. 
-  PCR or antigen test required predose on Day 1 of every cycle and upon suspected exposure to COVID-19 and at signs or symptoms of COVID19 infection.
			Imaging
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	X-ray/CT - Imaging to assess respiratory infection. 
-  Establish baseline lung image (X-ray/CT) within 7 days prior to randomization. 
-  If imaging for disease assessment was done during this period and allows adequate lung evaluation, it may be used.