Protocol Index	

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OP RESEARCH PRO00033043 CTO53-MM-02 (LUMMICAR STUDY 2) GANGULY	

Types:      Research Oncology Treatment
Synonyms:  CAR-T, CAR T, BCMA

Assessment	Repeat 1 time	Cycle length: 55 days	Screening Day -60 to -13	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Sign informed consent.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Collect demohgraphic information.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Collect myeloma history and treatment history.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Obtain medical history.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Inclusion/exclusion criteria.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medication review.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	ECOG performance status
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Examine the patient for cutaneous EMD lesions. A full-color picture with ruler shall be taken and submitted for IRC assessment for each cutaneous lesion.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Comprehensive physical examination.
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --			Imaging
◉	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	OR Echocardiogram
		◯	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	OR MUGA
			Nursing Orders
  	SPIROMETRY PRE AND POST WITH BRONCHILATOR	Interval: --	Occurrences: --		  	BODY PLETHYSMOGRAPHIC LUNG VOLUMES	Interval: --	Occurrences: --		  	DIFFUSION CAPACITY	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Only for females of childbearing potential
			Labs
  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	HUMAN IMMUNODEFICIENCY VIRUS 1 (HIV-1), QUANTITATIVE PCR (NIH)	Interval: --	Occurrences: --		  	COVID-19 QUALITATIVE RT-PCR	Interval: --	Occurrences: --	Comments:	Excluded from study if infection is active, but can be included at later date with negative resulted test per treating physician discretion
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	GLOMERULAR FILTRATION RATE, ESTIMATED (EGFR)	Interval: --	Occurrences: --	Comments:	Performed ONLY at LabCorp
			Labs
  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --		  	BETA-2 MICROGLOBULIN	Interval: --	Occurrences: --		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	PROTEIN, URINE, 24 HOUR	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Procedures
  	BIOPSY BONE MARROW	Interval: --	Occurrences: --	Comments:	Please schedule manually per unit protocol. 
Cytogenetics from FISH can be established within the last 12 months through the end of Baseline (Day -6). Bone marrow cytogenetic examination (FISH) will include at least t(4;14), t(14,16), t(14,20), del(17/17p), and gain(1q). Patients whose historical tests were positive for del(17p) and/or gain(1q) will need to have del(17p) and/or gain(1q) tests repeated for the study.
			Imaging
☑	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Images to be submitted to Independent Review Committee (IRC). Same imaging modality used at screening will be used for follow-up scans+
		☑	PET CT WHOLE BODY	Interval: --	Occurrences: --	Comments:	Preferred method
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --		☐	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --		☐	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --		☐	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --				Leukapheresis Day -42 to -28	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medication review.
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	If needed, bridging therapy is permitted after leukapheresis and completed at least 14 days prior to lymphodepletion. The patient should have prior exposure to the selected bridging therapy agents. Suggested options include: 
o Pomalidomide, cyclophosphamide and dexamethasone; 
o Carfilzomib, pomalidomide and dexamethasone; 
o Either daratumumab or isatuximab, with either carfilzomib or pomalidomide, and dexamethasone; 
o Two-drug combination selected from above options is preferred for patients with stable disease, impaired organ function, or worse clinical conditions.
				Baseline Day -12 to -6	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Collect myeloma history and treatment history.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Inclusion/exclusion criteria.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Complete EORTC QLQ-C30, QLQ-MY20 surveys .
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Collect Adverse events related to leukapheresis.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medication review.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Brief physical exam including weight and ECOG.
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Examine the patient for cutaneous EMD lesions. A full-color picture with ruler shall be taken and submitted for IRC assessment for each cutaneous lesion.
			Imaging
◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	OR Echocardiogram. Only order if new arrhythmia, new exam finding, or bridging therapy conducted with potentially cardiotoxic drug.
		◯	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	OR MUGA. Only order if new arrhythmia, new exam finding, or bridging therapy conducted with potentially cardiotoxic drug.
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Only done if subject has new arrhythmia, new exam findings, or if bridging therapy included a cycle of a potentially cardiotoxic drug.
			Labs
  	COVID-19 QUALITATIVE RT-PCR	Interval: --	Occurrences: --	Comments:	Excluded from study if infection is active, but can be included at later date with negative resulted test per treating physician discretion
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	GLOMERULAR FILTRATION RATE, ESTIMATED (EGFR)	Interval: --	Occurrences: --	Comments:	Performed ONLY at LabCorp
		  	NT-PROBNP	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	FERRITIN LEVEL	Interval: --	Occurrences: --			Labs
  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --		  	BETA-2 MICROGLOBULIN	Interval: --	Occurrences: --		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	PROTEIN, URINE, 24 HOUR	Interval: --	Occurrences: --			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: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	ONC PROVIDER COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	After infusion, patients presenting with neurotoxicity will have HHV assessed locally for rising titers" to clarify which patients require this assessment.
		  	HUMAN HERPESVIRUS 6, QUANTITATIVE PCR	Interval: --	Occurrences: --		  	HHV-7 QPCR - VIRACOR	Interval: --	Occurrences: --		  	HHV-8 QPCR - VIRACOR	Interval: --	Occurrences: --			Labs
☐	INTERLEUKIN 6	Interval: --	Occurrences: --		☐	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Performed in-house ONLY at HMH and HMCL
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serum total IgD/IgE only required if serum M protein can't be followed for IgD/IgE myeloma patients.
			Labs
  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --			Procedures
  	BIOPSY BONE MARROW	Interval: --	Occurrences: --	Comments:	Please schedule manually per unit protocol. 
Aspiration/Biopsy performed per standard of care. 
Required samples: 
A. pathology evaluation to quantify percentage of plasma cells in the aspirate per standard of care (local laboratories); 
B. central lab* (Adaptive) MRD evaluation via clonoSEQ per IMWG 2016; baseline sample requires 1 mL BMA (early pull preferred) collected in standard EDTA tube, frozen and stored at -80 degrees celcius (preferred option) or when baseline BMA is not available, BMA smear or BMA FFPE slides sample may be used as calibration sample after medical monitor's approval: GREATER than or EQUAL to 25 microns (~5 slides, 5 microns each). *For previously enrolled patients whose baseline samples were not sent to a central lab, MRD evaluation will continue to be conducted locally per standard of care;  
C. central lab (Covance) BCMA expression evaluation per IMWG 2016; 
D. for core bone marrow biopsy: (a) pathology evaluation to quantify percentage of plasma cells and (b) immunohistochemistry are required.
			Imaging
☑	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	PET/CT is preferred. MRI or CT can be used as well. Images to be submitted to Independent Review Committee (IRC). Must match same modality used for scan at screening.
		☑	PET CT WHOLE BODY	Interval: --	Occurrences: --	Comments:	Preferred method
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --		☐	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --		☐	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --		☐	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --					
Lymphodepletion	Repeat 1 time	Cycle length: 5 days	Day -5	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	For patients with a baseline CrCl of 30-45 mL/min, reduce fludarabine dose to 20mg/m2.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medication review.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Review adverse events.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Brief physical exam including weight and ECOG.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Only for females of childbearing potential. 
To be run prior to lymphodepletion start. Women of child-bearing potential (WOCBP).
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	To be run prior to lymphodepletion and may be repeated during this period as medically needed.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	GLOMERULAR FILTRATION RATE, ESTIMATED (EGFR)	Interval: --	Occurrences: --	Comments:	Performed ONLY at LabCorp
			Pre-Hydration
  	sodium chloride 0.9 % infusion	Dose: 150 mL/hr	Route: intravenous	continuous	Start: S			Instructions:	o On days -5 and -4. 
o Start 1 hour prior to chemotherapy and continue until all chemotherapy is complete.			Pre-Medications
  	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Give 30 minutes before chemo on days -5 and -4.		  	LORAZepam (ATIVAN) tablet 0.5 mg	Dose: 0.5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Give 30 minutes before chemo on days -5 and -4.			Chemotherapy
  	mesna (MESNEX) 250 mg/m2 in sodium chloride 0.9% 100 mL chemo IVPB	Dose: 250 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Administer before Mesna/Cyclophosphamide infusion	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	MESNA 100 MG/ML INTRAVENOUS SOLUTION	Medications	250 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes			  	cycloPHOSphamide (CYTOXAN) 500 mg/m2, mesna (MESNEX) 500 mg/m2 in dextrose 5% 500 mL chemo IVPB	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 60 Minutes	Instructions:	Administer immediately after mesna bolus.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CYCLOPHOSPHAMIDE 1 GRAM INTRAVENOUS POWDER FOR SOLUTION	Medications	500 mg/m2	Yes	Yes	MESNA 100 MG/ML INTRAVENOUS SOLUTION	Medications	500 mg/m2	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes			  	fludarabine (FLUDARA) 30 mg/m2 in sodium chloride 0.9% 100 mL chemo IVPB	Dose: 30 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours	Instructions:	For patients with creatinine clearance 30-45 mL/min at baseline: recommended dose reduction by 10mg/m2  to 20mg/m2/day.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	FLUDARABINE 50 MG/2 ML INTRAVENOUS SOLUTION	Medications	30 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day -4	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	For patients with a baseline CrCl of 30-45 mL/min, reduce fludarabine dose to 20mg/m2.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medication review.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Review adverse events.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Brief physical exam including weight and ECOG.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Only for females of childbearing potential. 
To be run prior to lymphodepletion start. Women of child-bearing potential (WOCBP).
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	To be run prior to lymphodepletion and may be repeated during this period as medically needed.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	GLOMERULAR FILTRATION RATE, ESTIMATED (EGFR)	Interval: --	Occurrences: --	Comments:	Performed ONLY at LabCorp
			Pre-Hydration
  	sodium chloride 0.9 % infusion	Dose: 150 mL/hr	Route: intravenous	continuous	Start: S			Instructions:	o On days -5 and -4. 
o Start 1 hour prior to chemotherapy and continue until all chemotherapy is complete.			Pre-Medications
  	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Give 30 minutes before chemo on days -5 and -4.		  	LORAZepam (ATIVAN) tablet 0.5 mg	Dose: 0.5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Give 30 minutes before chemo on days -5 and -4.			Chemotherapy
  	mesna (MESNEX) 250 mg/m2 in sodium chloride 0.9% 100 mL chemo IVPB	Dose: 250 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Administer before Mesna/Cyclophosphamide infusion	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	MESNA 100 MG/ML INTRAVENOUS SOLUTION	Medications	250 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes			  	cycloPHOSphamide (CYTOXAN) 500 mg/m2, mesna (MESNEX) 500 mg/m2 in dextrose 5% 500 mL chemo IVPB	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 60 Minutes	Instructions:	Administer immediately after mesna bolus.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CYCLOPHOSPHAMIDE 1 GRAM INTRAVENOUS POWDER FOR SOLUTION	Medications	500 mg/m2	Yes	Yes	MESNA 100 MG/ML INTRAVENOUS SOLUTION	Medications	500 mg/m2	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes			  	fludarabine (FLUDARA) 30 mg/m2 in sodium chloride 0.9% 100 mL chemo IVPB	Dose: 30 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours	Instructions:	For patients with creatinine clearance 30-45 mL/min at baseline: recommended dose reduction by 10mg/m2  to 20mg/m2/day.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	FLUDARABINE 50 MG/2 ML INTRAVENOUS SOLUTION	Medications	30 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day -3	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	For patients with a baseline CrCl of 30-45 mL/min, reduce fludarabine dose to 20mg/m2.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medication review.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Review adverse events.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Brief physical exam including weight and ECOG.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Only for females of childbearing potential. 
To be run prior to lymphodepletion start. Women of child-bearing potential (WOCBP).
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	To be run prior to lymphodepletion and may be repeated during this period as medically needed.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	GLOMERULAR FILTRATION RATE, ESTIMATED (EGFR)	Interval: --	Occurrences: --	Comments:	Performed ONLY at LabCorp
			Pre-Medications
  	ondansetron (ZOFRAN) tablet 8 mg	Dose: 8 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Give 30 minutes before chemo on days -5 and -4.			Chemotherapy
  	fludarabine (FLUDARA) 30 mg/m2 in sodium chloride 0.9% 100 mL chemo IVPB	Dose: 30 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	For patients with creatinine clearance 30-45 mL/min at baseline: recommended dose reduction by 10mg/m2  to 20mg/m2/day.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	FLUDARABINE 50 MG INTRAVENOUS SOLUTION	Medications	30 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
CAR-BCMA T cells (CT053) Infusion	Repeat 1 time	Cycle length: 1 day	Day 0	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	CAGT team to administer Zevor-cel and document in Epic. Research coordinator to assist with paper forms.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Review inclusion/exclusion criteria to verify eligibility prior to infusion.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Review adverse events
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Prior to infusion, verify with pharmacy that 2 doses of tocilizumab are available and set aside for this patient.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Anaphylaxis precautions at bedside during CAR-T infusion and for 24 hours after infusion complete.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	To be canceled if >5 days after lymphodepletion. Patients excluded if O2 is needed to keep saturation above 90%.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Brief physical exam including weight.
			Nursing Orders
  	PULSE OXIMETRY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	GLOMERULAR FILTRATION RATE, ESTIMATED (EGFR)	Interval: --	Occurrences: --	Comments:	Performed ONLY at LabCorp
		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	FERRITIN LEVEL	Interval: --	Occurrences: --			Labs
☐	INTERLEUKIN 6	Interval: --	Occurrences: --		☐	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Performed in-house ONLY at HMH and HMCL
			Pre-Medications
  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Within 30 minutes prior to T-cell infusion.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Within 30 minutes prior to T-cell infusion.			Emergency Medications
  	meperidine (DEMEROL) injection (RESTRICTED) 12.5 mg	Dose: 12.5 mg	Route: intravenous	every 15 min PRN for 3 doses	Start: S			Instructions:	If Rigors persist, contact MD.		  	epINEPHrine (ADRENALIN) injection 1 mg/mL 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S					Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 CRS - Fever or Organ Toxicity
1. Acetaminophen and hypothermia blanket for the treatment of fever; 
2. Ibuprofen can be used as second treatment option for fever, if not contraindicated; 
3. Assess for infection using blood and urine cultures, and chest radiography;  
4. Empiric broad-spectrum antibiotics and filgrastim if neutropenic;  
5. Maintenance intravenous (IV) fluids for hydration; 
6. Symptomatic management of constitutional symptoms and organ toxicities; 
7. Consider tocilizumab 8mg/kg* IV for persistent (lasting>3 days) and refractory fever.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 CRS: 
Hypotension
1. IV fluid bolus of 50 0-1,000ml of normal saline; 
2. Can give a second IV fluid bolus if SBP remains <90 mmHg; 
3. Tocilizumab 8mg/kg IV for the treatment of hypotension that is refractory to fluid boluses.  Tocilizumab can be repeated after 6h if needed; 
4. If hypotension persists after two fluid boluses and anti-lL-6 therapy, start    vasopressors, consider transfer to ICU, obtain echocardiogram and initiate other methods of hemodynamic monitoring; 
5. In patients at high-risk+ or if hypotension persists after 1-2 doses of anti-lL-6 therapy, dexamethasone can be used at 10mg IV every 6 h; 
6. Manage fever and constitutional symptoms as in grade 1. 

Hypoxia
1. Supplemental oxygen; 
2. Tocilizumab ± corticosteroids and supportive care, as recommended for the management of hypotension. 

Organ toxicity
1. Symptomatic management of organ toxicities, as per standard guidelines; 
2. Tocilizumab ± corticosteroids and supportive care, as indicated for hypotension.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 CRS: 
Hypotension
1. IV fluid boluses as needed, as recommended for the treatment of grade 2 CRS; 
2. Tocilizumab as recommended for grade 2 CRS, if not administered previously; 
3. Vasopressors as needed; 
4. Transfer to ICU, obtain echocardiogram, and perform hemodynamic monitoring as in the management of grade 2 CRS; 
5. Dexamethasone 10 mg IV every 6h; if refractory, increase to 20 mg IV every 6h; 
6. Manage fever and constitutional symptoms as indicated for grade 1 CRS. 

Hypoxia
1. Supplemental oxygen including high-flow oxygen delivery and noninvasive positive pressure ventilation;  
2. Tocilizumab plus corticosteroids and supportive care, as described above. 

Organ toxicity
1. Symptomatic management of organ toxicities, as per standard guidelines; 
2. Tocilizumab plus corticosteroids and supportive care, as described above.
		  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	Grade 4 CRS: 
Hypotension
1. IV fluid s, anti-lL-6 therapy, vasopressors, and hemodynamic monitoring as defined for the management of grade 3 CRS; 
2. Methylprednisolone 1 g/day IV; 
3. Manage fever and constitutional symptoms as in grade 1 CRS. 

Hypoxia
1. Mechanical ventilation; 
2. Tocilizumab plus corticosteroids and supportive care, as described above. 

Organ Toxicity 
1. Symptomatic management of organ toxicities as per standard guidelines 
2. Tocilizumab plus corticosteroids and supportive care, as described above
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	Grade 1 CRES: 
o Vigilant supportive care; aspiration precautions; intravenous (IV)hydration; 
o Withhold oral intake of food, medicines, and fluids, and assess swallowing;  
o Convert all oral medications and/or nutrition to IV if swallowing is impaired;  
o Avoid medications that cause central nervous system depression; 
o Low doses of lorazepam (0.25-0.5 mg IV every 8 h) or haloperidol (0.5 mg IV every 6 h) can be used, with careful monitoring, for agitated patients; 
o Neurology consultation - Fundoscopic exam to assess for papilledema; 
o MRI of the brain with and without contrast; diagnostic lumbar puncture with measurement of opening pressure; MRI spine if the patient has focal peripheral neurological deficits; CT scan of the brain can be performed if MRI of the brain is not feasible; 
o Daily 30 min electroencephalogram (EEG) until toxicity symptoms resolve; if no seizures are detected on EEG, continue levetiracetam 750mg every 12 h; 
o If EEG shows nonconvulsive status epileptic us, treat as per BOX 3; 
o Consider anti-lL-6 therapy with tocilizumab 8 mg/kg* IV, if CRES is associated with concurrent cytokine release syndrome (CRS).
		  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	Grade 2 CRES: 
o Supportive care and neurological work-up as described for grade 1 CRES; 
o Tocilizumab 8 mg/kg* IV if associated with concurrent CRS; 
o Dexamethasone 10mg IV every 6 h or methylprednisolone 1 mg/kg IV every 12 h if refractory to anti-lL-6 therapy, or for CRES without concurrent CRS; 
o Consider transferring patient to intensive-care unit (ICU) if CRES associated with grade GREATER than or EQUAL to 2 CRS.
		  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Grade 3 CRES: 
o Supportive care and neurological work-up as indicated for grade 1 CRES; 
o ICU transfer is recommended;  
o Anti-lL-6 therapy if associated with concurrent CRS, as described for grade 2 CRES and if not administered previously; 
o Corticosteroids as outlined for grade 2 CRES if symptoms worsen despite anti-lL-6 therapy, or for CRES without concurrent CRS; continue corticosteroids until improvement to grade 1 CRES and then taper; 
o Stage 1or 2 papilledema with cerebrospinal fluid (CSF) opening pressure.
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Grade 4 CRES: 
o Supportive care and neurological work-up as outlined for grade 1 CRES;  
o ICU monitoring; consider mechanical ventilation for airway protection; 
o Anti-lL-6 therapy and repeat neuroimaging as described for grade 3 CRES; 
o High-dose corticosteroids continued until improvement to grade 1 CRES and then taper; for example, methylprednisolone IV 1 g/day for 3 days, followed by rapid taper at 250 mg every 12 h for 2 days, 125 mg every 12 h for 2 days, and 60 mg every 12 h for 2 days; 
o For convulsive status epilepticus, treat as per algorithm in BOX 3 below; 
o Stage GREATER than or EQUAL to 3 papilledema, with a CSF opening pressure GREATER than or EQUAL to 20 mm Hg or cerebral oedema, should be treated as per ICP algorithm.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 71	Interval: --	Occurrences: --	Comments:	Non-Convulsive Epilepticus Management
o Assess airway, breathing, and circulation; check blood glucose;  
o Lorazepam* 0.5mg IV, with 0.5mg IV every 5 min, as needed, up to a total of 2 mg to control electrographical seizures; 
o Levetiracetam 500 mg IV bolus, as well as maintenance doses; 
o If seizures persist, transfer to ICU and treat with phenobarbital loading dose of 60mg IV; 
o Maintenance doses after resolution of nonconvulsive status epilepticus are as follows: lorazepam 0.5mg IV every 8 h for three doses; levetiracetam 1000 mg IV every 12 h; phenobarbital 30mg IV every 12 h.
		  	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Convulsive Epilepticus Management
o Assess airway, breathing, and circulation; check blood glucose; 
o Transfer to ICU;  
o Lorazepam* 2mg IV, with additional 2mg IV to a total of 4mg to control seizures; 
o Levetiracetam 500 mg IV bolus, as well as maintenance doses; 
o If seizures persist, transfer to ICU and treat with phenobarbital loading dose of 15mg/kg IV; 
o Maintenance doses after resolution of nonconvulsive status epilepticus are: lorazepam 0.5mg IV every 8 h for three doses; levetiracetam 1000 mg IV every 12 h; phenobarbital 1-3 mg/kg IV every 12 h; 
o Continuous electroencephalogram monitoring should be performed, if seizures are refractory to treatment.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	To be processed at central lab.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Post CAR-BCMA T cell	Repeat 1 time	Cycle length: 730 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Review adverse events
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	PULSE OXIMETRY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	GLOMERULAR FILTRATION RATE, ESTIMATED (EGFR)	Interval: --	Occurrences: --	Comments:	Performed ONLY at LabCorp
		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	FERRITIN LEVEL	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
☐	INTERLEUKIN 6	Interval: --	Occurrences: --		☐	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Performed in-house ONLY at HMH and HMCL
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	To be processed at central lab.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 3	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Review adverse events
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	PULSE OXIMETRY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	GLOMERULAR FILTRATION RATE, ESTIMATED (EGFR)	Interval: --	Occurrences: --	Comments:	Performed ONLY at LabCorp
		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	FERRITIN LEVEL	Interval: --	Occurrences: --			Labs
☐	INTERLEUKIN 6	Interval: --	Occurrences: --		☐	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Performed in-house ONLY at HMH and HMCL
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	To be processed at central lab.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 7	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Review adverse events
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	PULSE OXIMETRY	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	GLOMERULAR FILTRATION RATE, ESTIMATED (EGFR)	Interval: --	Occurrences: --	Comments:	Performed ONLY at LabCorp
		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	FERRITIN LEVEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
☐	INTERLEUKIN 6	Interval: --	Occurrences: --		☐	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Performed in-house ONLY at HMH and HMCL
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	To be processed at central lab.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 15	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Review adverse events
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Brief physical exam including weight.
			Nursing Orders
  	PULSE OXIMETRY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	GLOMERULAR FILTRATION RATE, ESTIMATED (EGFR)	Interval: --	Occurrences: --	Comments:	Performed ONLY at LabCorp
		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	FERRITIN LEVEL	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
☐	INTERLEUKIN 6	Interval: --	Occurrences: --		☐	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Performed in-house ONLY at HMH and HMCL
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	To be processed at central lab.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 29	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Review adverse events
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Complete EORTC QLQ-C30, QLQ-MY20 surveys
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Brief physical exam including weight.
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Examine the patient for cutaneous EMD lesions. A full-color picture with ruler shall be taken and submitted for IRC assessment for each cutaneous lesion.
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	GLOMERULAR FILTRATION RATE, ESTIMATED (EGFR)	Interval: --	Occurrences: --	Comments:	Performed ONLY at LabCorp
		  	NT-PROBNP	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	FERRITIN LEVEL	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
☐	INTERLEUKIN 6	Interval: --	Occurrences: --		☐	TUMOR NECROSIS FACTOR - ALPHA	Interval: --	Occurrences: --	Comments:	Performed in-house ONLY at HMH and HMCL
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serum total IgD/IgE only required if serum M protein can't be followed for IgD/IgE myeloma patients.
			Labs
  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --			Labs
  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	PROTEIN, URINE, 24 HOUR	Interval: --	Occurrences: --			Procedures
  	BIOPSY BONE MARROW	Interval: --	Occurrences: --	Comments:	o Please schedule manually per unit protocol. 
o Aspiration/Biopsy performed per standard of care. 
o Separate tubes required for pathology eval of plasma cells, MRD evaluation for central lab, and BCMA expression for central lab.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	To be processed at central lab.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Imaging
☑	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Performed for subjects with EMD identified at baseline only. 
PET/CT preferred. MRI or CT can be used as well. Same imaging modality used at screening will be used for additional scans.
		☑	PET CT WHOLE BODY	Interval: --	Occurrences: --	Comments:	Preferred method
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --		☐	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --		☐	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --		☐	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --			Imaging
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	If a cardiac end-organ toxicity persists after week 4, such as an event GREATER than or EQUAL to grade 2, NT-pro-BNP will be assessed. ECHO/MUGA must be conducted, and a specialist should be consulted.
			Imaging
◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	OR Echocardiogram. If a cardiac end-organ toxicity persists after week 4, such as an event GREATER than or EQUAL to grade 2, ECHO/MUGA must be conducted, and a specialist should be consulted.
		◯	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	OR MUGA. If a cardiac end-organ toxicity persists after week 4, such as an event GREATER than or EQUAL to grade 2, ECHO/MUGA must be conducted, and a specialist should be consulted.
				Day 57	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Review adverse events
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Brief physical exam including weight.
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Examine the patient for cutaneous EMD lesions. A full-color picture with ruler shall be taken and submitted for IRC assessment for each cutaneous lesion.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	GLOMERULAR FILTRATION RATE, ESTIMATED (EGFR)	Interval: --	Occurrences: --	Comments:	Performed ONLY at LabCorp
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serum total IgD/IgE only required if serum M protein can't be followed for IgD/IgE myeloma patients.
			Labs
  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --			Labs
  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	PROTEIN, URINE, 24 HOUR	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 85	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Review adverse events
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Brief physical exam including weight.
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Examine the patient for cutaneous EMD lesions. A full-color picture with ruler shall be taken and submitted for IRC assessment for each cutaneous lesion.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	GLOMERULAR FILTRATION RATE, ESTIMATED (EGFR)	Interval: --	Occurrences: --	Comments:	Performed ONLY at LabCorp
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serum total IgD/IgE only required if serum M protein can't be followed for IgD/IgE myeloma patients.
			Labs
  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --			Labs
  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	PROTEIN, URINE, 24 HOUR	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 113	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Review adverse events
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Complete EORTC QLQ-C30, QLQ-MY20 surveys
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Brief physical exam including weight.
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Examine the patient for cutaneous EMD lesions. A full-color picture with ruler shall be taken and submitted for IRC assessment for each cutaneous lesion.
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Only for females of childbearing potential
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	GLOMERULAR FILTRATION RATE, ESTIMATED (EGFR)	Interval: --	Occurrences: --	Comments:	Performed ONLY at LabCorp
		  	NT-PROBNP	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	FERRITIN LEVEL	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serum total IgD/IgE only required if serum M protein can't be followed for IgD/IgE myeloma patients.
			Labs
  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --			Labs
  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --		  	BETA-2 MICROGLOBULIN	Interval: --	Occurrences: --		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	PROTEIN, URINE, 24 HOUR	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Procedures
  	BIOPSY BONE MARROW	Interval: --	Occurrences: --	Comments:	o Please schedule manually per unit protocol. 
o Aspiration/Biopsy performed per standard of care. 
o Separate tubes required for pathology eval of plasma cells, MRD evaluation for central lab, and BCMA expression for central lab.
			Imaging
☑	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Performed for subjects with EMD identified at baseline only. 
PET/CT preferred. MRI or CT can be used as well. Same imaging modality used at screening will be used for additional scans.
		☑	PET CT WHOLE BODY	Interval: --	Occurrences: --	Comments:	Preferred method
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --		☐	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --		☐	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --		☐	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --			Imaging
  	ONC PROVIDER COMMUNICATION 7	Interval: --	Occurrences: --	Comments:	If a cardiac end-organ toxicity persists after week 4, such as an event GREATER than or EQUAL to grade 2, NT-pro-BNP will be assessed. ECHO/MUGA must be conducted, and a specialist should be consulted.
			Imaging
◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	OR Echocardiogram. If a cardiac end-organ toxicity persists after week 4, such as an event GREATER than or EQUAL to grade 2, ECHO/MUGA must be conducted, and a specialist should be consulted.
		◯	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	OR MUGA. If a cardiac end-organ toxicity persists after week 4, such as an event GREATER than or EQUAL to grade 2, ECHO/MUGA must be conducted, and a specialist should be consulted.
				Day 181	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Review adverse events
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Complete EORTC QLQ-C30, QLQ-MY20 surveys
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Brief physical exam including weight.
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Examine the patient for cutaneous EMD lesions. A full-color picture with ruler shall be taken and submitted for IRC assessment for each cutaneous lesion.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	GLOMERULAR FILTRATION RATE, ESTIMATED (EGFR)	Interval: --	Occurrences: --	Comments:	Performed ONLY at LabCorp
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serum total IgD/IgE only required if serum M protein can't be followed for IgD/IgE myeloma patients.
			Labs
  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --			Labs
  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --		  	BETA-2 MICROGLOBULIN	Interval: --	Occurrences: --		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	PROTEIN, URINE, 24 HOUR	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Imaging
☑	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Performed for subjects with EMD identified at baseline only. 
PET/CT preferred. MRI or CT can be used as well. Same imaging modality used at screening will be used for additional scans.
		☑	PET CT WHOLE BODY	Interval: --	Occurrences: --	Comments:	Preferred method
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --		☐	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --		☐	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --		☐	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --				Day 225	Perform every 56 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Review adverse events
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Complete EORTC QLQ-C30, QLQ-MY20 surveys
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Brief physical exam including weight.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	GLOMERULAR FILTRATION RATE, ESTIMATED (EGFR)	Interval: --	Occurrences: --	Comments:	Performed ONLY at LabCorp
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serum total IgD/IgE only required if serum M protein can't be followed for IgD/IgE myeloma patients.
			Labs
  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --			Labs
  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	PROTEIN, URINE, 24 HOUR	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 281	Perform every 56 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Review adverse events
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Complete EORTC QLQ-C30, QLQ-MY20 surveys
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Brief physical exam including weight.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	GLOMERULAR FILTRATION RATE, ESTIMATED (EGFR)	Interval: --	Occurrences: --	Comments:	Performed ONLY at LabCorp
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serum total IgD/IgE only required if serum M protein can't be followed for IgD/IgE myeloma patients.
			Labs
  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --			Labs
  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	PROTEIN, URINE, 24 HOUR	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 337	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Review adverse events
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Complete EORTC QLQ-C30, QLQ-MY20 surveys
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Brief physical exam including weight.
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Examine the patient for cutaneous EMD lesions. A full-color picture with ruler shall be taken and submitted for IRC assessment for each cutaneous lesion.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	GLOMERULAR FILTRATION RATE, ESTIMATED (EGFR)	Interval: --	Occurrences: --	Comments:	Performed ONLY at LabCorp
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serum total IgD/IgE only required if serum M protein can't be followed for IgD/IgE myeloma patients.
			Labs
  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --			Labs
  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	PROTEIN, URINE, 24 HOUR	Interval: --	Occurrences: --			Procedures
  	BIOPSY BONE MARROW	Interval: --	Occurrences: --	Comments:	o Please schedule manually per unit protocol. 
o Aspiration/Biopsy performed per standard of care. 
o Separate tubes required for pathology eval of plasma cells, MRD evaluation for central lab, and BCMA expression for central lab.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Imaging
☑	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Performed for subjects with EMD identified at baseline only. 
PET/CT preferred. MRI or CT can be used as well. Same imaging modality used at screening will be used for additional scans.
		☑	PET CT WHOLE BODY	Interval: --	Occurrences: --	Comments:	Preferred method
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --		☐	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --		☐	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --		☐	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --				Day 421	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Review adverse events
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Brief physical exam including weight.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serum total IgD/IgE only required if serum M protein can't be followed for IgD/IgE myeloma patients.
			Labs
  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --			Labs
  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	PROTEIN, URINE, 24 HOUR	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 505	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Review adverse events
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Complete EORTC QLQ-C30, QLQ-MY20 surveys
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Brief physical exam including weight.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	GLOMERULAR FILTRATION RATE, ESTIMATED (EGFR)	Interval: --	Occurrences: --	Comments:	Performed ONLY at LabCorp
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serum total IgD/IgE only required if serum M protein can't be followed for IgD/IgE myeloma patients.
			Labs
  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --			Labs
  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	PROTEIN, URINE, 24 HOUR	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 589	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Review adverse events
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Brief physical exam including weight.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serum total IgD/IgE only required if serum M protein can't be followed for IgD/IgE myeloma patients.
			Labs
  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --			Labs
  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	PROTEIN, URINE, 24 HOUR	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 673	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Review adverse events
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Complete EORTC QLQ-C30, QLQ-MY20 surveys
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Brief physical exam including weight.
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Examine the patient for cutaneous EMD lesions. A full-color picture with ruler shall be taken and submitted for IRC assessment for each cutaneous lesion.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	GLOMERULAR FILTRATION RATE, ESTIMATED (EGFR)	Interval: --	Occurrences: --	Comments:	Performed ONLY at LabCorp
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serum total IgD/IgE only required if serum M protein can't be followed for IgD/IgE myeloma patients.
			Labs
  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --			Labs
  	SERUM ELECTROPHORESIS	Interval: --	Occurrences: --		  	IMMUNOFIXATION, SERUM	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	KAPPA LAMBDA FREE LIGHT CHAIN WITH RATIO	Interval: --	Occurrences: --		  	URINE PROTEIN ELECTROPHORESIS, 24 HOUR	Interval: --	Occurrences: --		  	IMMUNOFIXATION, URINE	Interval: --	Occurrences: --	Comments:	Perform in-house ONLY at HMH
		  	PROTEIN, URINE, 24 HOUR	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Procedures
  	BIOPSY BONE MARROW	Interval: --	Occurrences: --	Comments:	o Please schedule manually per unit protocol. 
o Aspiration/Biopsy performed per standard of care. 
o Separate tubes required for pathology eval of plasma cells, MRD evaluation for central lab, and BCMA expression for central lab.
			Imaging
☑	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Performed for subjects with EMD identified at baseline only. 
PET/CT preferred. MRI or CT can be used as well. Same imaging modality used at screening will be used for additional scans.
		☑	PET CT WHOLE BODY	Interval: --	Occurrences: --	Comments:	Preferred method
		☐	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --		☐	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --		☐	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --		☐	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --