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OP RESEARCH PRO00037762 / HMCC-HM22-001 ATRA SCREENING / BASELINE	

Types:      Research Oncology Treatment
Synonyms:  PRE-SCREENING, BASELINE

Screening	Repeat 1 time	Cycle length: 28 days	Day -28	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:   HMCC-HM22-001_Pingali_ATRA_NotIRBApproved
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment : Carfilzomib Refer to Section 6.2.1.  Protocol Access hyperlink:   HMCC-HM22-001_Pingali_ATRA_NotIRBApproved
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment : Carfilzomib Refer to Section 6.2.1.  See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   HMCC-HM22-001_Pingali_ATRA_NotIRBApproved
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Written informed consent is required before performing any trial-specific tests or procedures. Signing of the informed consent form can occur outside the 28-day screening period
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Physical exam and ECOG will be performed at screening/baseline before every cycle and at end of treatment (EOT). Weight will be measured at each physical exam. Height will be measured at screening only.
					
Baseline	Repeat 1 time	Cycle length: 10 days	Day -10	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:   HMCC-HM22-001_Pingali_ATRA_NotIRBApproved
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment : Carfilzomib Refer to Section 6.2.1.  Protocol Access hyperlink:   HMCC-HM22-001_Pingali_ATRA_NotIRBApproved
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment : Carfilzomib Refer to Section 6.2.1.  See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   HMCC-HM22-001_Pingali_ATRA_NotIRBApproved
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Written informed consent is required before performing any trial-specific tests or procedures. Signing of the informed consent form can occur outside the 28-day screening period
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Physical exam and ECOG will be performed at screening/baseline before every cycle and at end of treatment (EOT). Weight will be measured at each physical exam. Height will be measured at screening only.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Obtain medical history
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	All concomitant medications received within 28 days before the start of trial treatment and 30 days after the last dose of trial treatment should be recorded. Concomitant medications administered 30 days after the last dose of trial treatment should be recorded for SAEs and events of clinical interest (ECIs) as defined in Section 7.2.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Record all reportable events with start dates occurring any time after treatment start or informed consent (related to baseline biopsy only) is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. 
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs to include - HR, BP, Temp, RR, Oxygen Saturation
			Nursing Orders
  	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	Multigated acquisition (MUGA) scan or echocardiogram (ECHO) will be performed at screening and when clinically indicated. The same method (MUGA scan or ECHO) must be used throughout the duration of the trial.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	12-lead electrocardiogram (ECG) will be performed at screening
			Labs
  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --	Comments:	Kappa: lambda ratio and serum protein electrophoresis will be performed at baseline, cycle 2 day 1, cycle 3 day 1, at 4 months, at 6 months, and at EOT.
		  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --	Comments:	Kappa: lambda ratio and serum protein electrophoresis will be performed at baseline, cycle 2 day 1, cycle 3 day 1, at 4 months, at 6 months, and at EOT.
		  	BIOPSY BONE MARROW	Interval: --	Occurrences: --	Comments:	Bone marrow biopsy and aspiration will be done at baseline and cycle 3 day 1. It may be repeated at a short interval or after cycle 3 day 1 if there is clinical suspicion that warrants a bone marrow biopsy for confirmation of progressive disease, according to clinician discretion. We will collect BM specimen in 1 6ml green top (5 ml) and peripheral blood samples in 1 6ml green top (5ml), stored at room temperature in Dr. Qing Yi's Lab at various time points as described in the study calendar for correlative studies and disease response
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Correlative studies:  Biopsy Blood:  Blood samples (up to 60 ml) for standard of care and 15 ml for research will be collected at baseline and before each cycle into standard vacutainer tubes, 1 red top (5 ml), 2 6 ml green tops (10 ml), stored at room temperature in Dr. Qing Yi's Lab in Smith 8 and processed for plasma and viable cryopreserved peripheral blood mononuclear cells for subsequent batched analyses
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Correlative studies:  Biopsy Blood:  Blood samples (up to 60 ml) for standard of care and 15 ml for research will be collected at baseline and before each cycle into standard vacutainer tubes, 1 red top (5 ml), 2 6 ml green tops (10 ml), stored at room temperature in Dr. Qing Yi's Lab in Smith 8 and processed for plasma and viable cryopreserved peripheral blood mononuclear cells for subsequent batched analyses
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum ß-hCG pregnancy testing is to be performed, except in postmenopausal women or those who have had a hysterectomy, at initial screening within 21 days of initiation of therapy and again within 72 hours of initiation of therapy. Serum ß-hCG pregnancy testing will be performed whenever an expected menstrual cycle is missed or when pregnancy is a possibility.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with platelet count and differential WBC count will be performed at screening/baseline, and then weekly for the entirety of treatment duration, and when clinically indicated
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) will be performed at screening/baseline, then weekly for the entirety of treatment, at EOT and when clinically indicated. Fasting glucose at baseline, and weekly for the entirety of treatment duration, and clinically when indicated.  
		  	LDH	Interval: --	Occurrences: --	Comments:	Lactate dehydrogenase will be performed at baseline, cycle 3 day 1, and when clinically indicated
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Urine protein electrophoresis will be performed if the patient is suspected or known to have urine protein.