A Study of Vadastuximab Talirine Given Prior to or After... | NCT02614560

Label	Type	Description	Intervention Names
Pre-allo (before stem cell transplant)	Experimental	Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)	Drug: Fludarabine Drug: Melphalan Drug: vadastuximab talirine
Post-allo (after stem cell transplant)	Experimental	Post-allo vadastuximab talirine	Drug: vadastuximab talirine

Name	Type	Description	Arm Group Labels	Other Names
Fludarabine	Drug	30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)	Pre-allo (before stem cell transplant)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Adverse Events	AE: Adverse events; TEAE: Treatment-emergent adverse event. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event. An AE is considered serious if it was fatal, life threatening, required hospitalization, was disabling/incapacitating, resulted in a birth defect or congenital anomally, or was otherwise considered to be medically significant.	Approximately 1 year
Incidence of Laboratory Abnormalities	Number (count) of participants that experienced a Grade 3 or higher laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event.	Approximately 1 year
1-year Survival Rate	1-year survival rate estimated using Kaplan-Meier methods The start date for overall survival is the day of alloSCT.	12 months
Rate of MRD Negativity	Rate of MRD (minimal residual disease) negativity at Day -1 (1 day prior to transplant) and Day 30 post-transplant (Part A only)	30 days

Secondary Outcomes

Measure	Description	Time Frame
Best Response of CR or CRi	Percentage of patients who achieved a best response of CRi (complete remission with incomplete blood count recovery) or CR (complete remission)	9 weeks
Duration of Response

Eligibility Module

Name	Affiliation	Role
Phillip Garfin, MD, PhD	Seagen Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope National Medical Center		Duarte	California	91010-3000	United States
Colorado Blood Cancer Institute

ID	Title	Description
FG000	Pre-allo (Before Stem Cell Transplant)	Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine) Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2) Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 15, 2017	Sep 5, 2018

ID	Title	Description
BG000	Pre-allo (Before Stem Cell Transplant)	Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine) Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2) Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
BG001	Post-allo (After Stem Cell Transplant)	Post-allo vadastuximab talirine vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0006 BG0018 BG00214

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Incidence of Adverse Events

AE: Adverse events; TEAE: Treatment-emergent adverse event. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event. An AE is considered serious if it was fatal, life threatening, required hospitalization, was disabling/incapacitating, resulted in a birth defect or congenital anomally, or was otherwise considered to be medically significant.

Posted

Count of Participants

Participants

Approximately 1 year

ID	Title	Description
OG000	Pre-allo (Before Stem Cell Transplant)	Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine) Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2) Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
OG001	Post-allo (After Stem Cell Transplant)	Post-allo vadastuximab talirine vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle

Units	Counts
Participants	OG0006 OG0018

Title

Denominators

Categories

TEAEs

Title	Measurements
	OG0006 OG0018

AEs Related to Vadatuximab Talirine

Title	Measurements
	OG000

Primary

Incidence of Laboratory Abnormalities

Number (count) of participants that experienced a Grade 3 or higher laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event.

Posted

Count of Participants

Participants

Approximately 1 year

ID	Title	Description
OG000	Pre-allo (Before Stem Cell Transplant)	Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine) Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2) Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
OG001	Post-allo (After Stem Cell Transplant)	Post-allo vadastuximab talirine vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle

Units	Counts

Primary

1-year Survival Rate

1-year survival rate estimated using Kaplan-Meier methods The start date for overall survival is the day of alloSCT.

All treated patients set

Posted

Number

95% Confidence Interval

percentage of participants

12 months

ID	Title	Description
OG000	Pre-allo (Before Stem Cell Transplant)	Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine) Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2) Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
OG001	Post-allo (After Stem Cell Transplant)	Post-allo vadastuximab talirine vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle

Units	Counts
Participants	OG000

Primary

Rate of MRD Negativity

Rate of MRD (minimal residual disease) negativity at Day -1 (1 day prior to transplant) and Day 30 post-transplant (Part A only)

All treated patients set, pre-allo cohort

Posted

Number

95% Confidence Interval

Percentage of participants

30 days

ID	Title	Description
OG000	Pre-allo (Before Stem Cell Transplant)	Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine) Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2) Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant

Units	Counts
Participants	OG000

Secondary

Best Response of CR or CRi

Percentage of patients who achieved a best response of CRi (complete remission with incomplete blood count recovery) or CR (complete remission)

Part A (pre-alloSCT) only

Posted

Count of Participants

Participants

9 weeks

ID	Title	Description
OG000	Pre-allo (Before Stem Cell Transplant)	Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine) Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2) Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant

Units	Counts
Participants	OG000

Secondary

Duration of Response

Defined as the time from the start of the first documented complete response (CR) or complete remission with incomplete blood count recovery (CRi) to the documentation of relapse or death due to any cause.

Part A (pre-alloSCT) only

Posted

Median

Full Range

weeks

9 weeks

ID	Title	Description
OG000	Pre-allo (Before Stem Cell Transplant)	Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine) Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2) Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant

Units	Counts
Participants	OG000

Secondary

Overall Survival

Defined as the time from the day of alloSCT to the date of death due to any cause.

Posted

Median

Full Range

weeks

Approximately 96 weeks

ID	Title	Description
OG000	Pre-allo (Before Stem Cell Transplant)	Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine) Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2) Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
OG001	Post-allo (After Stem Cell Transplant)	Post-allo vadastuximab talirine vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Pyrexia	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Venoocclusive liver disease	Hepatobiliary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Graft versus host disease in gastrointestinal tract	Immune system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Graft versus host disease in lung	Immune system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Device related infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Parotitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Pneumonia	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Sepsis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Urinary tract infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Neutrophil count decreased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Platelet count decreased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
White blood cell count decreased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected6 at risk EG0010 affected8 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Venoocclusive disease	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0011 affected8 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0013 affected8 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0015 affected8 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected6 at risk EG0015 affected8 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Atrial flutter	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Cardiomegaly	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Dry eye	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Eye discharge	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Eye pain	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Eye pruritus	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected6 at risk EG0010 affected8 at risk
Ascites	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Constipation	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0012 affected8 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected6 at risk EG0011 affected8 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Flatulence	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Nausea	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0005 affected6 at risk EG0012 affected8 at risk
Proctalgia	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected6 at risk EG0010 affected8 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Vomiting	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0004 affected6 at risk EG0012 affected8 at risk
Asthenia	General disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Chills	General disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected6 at risk EG0010 affected8 at risk
Face oedema	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0011 affected8 at risk
Fatigue	General disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected6 at risk EG0014 affected8 at risk
Malaise	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Non-cardiac chest pain	General disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected6 at risk EG0010 affected8 at risk
Oedema peripheral	General disorders	MedDRA (18.0)	Systematic Assessment	EG0005 affected6 at risk EG0011 affected8 at risk
Pyrexia	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0011 affected8 at risk
Graft versus host disease in eye	Immune system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Candida infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0011 affected8 at risk
Device related infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Enterococcal infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Pneumonia fungal	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Systemic candida	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Blood creatinine increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Respirovirus test positive	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Staphylococcus test positive	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Weight decreased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Weight increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
White blood cell count decreased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected6 at risk EG0010 affected8 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected6 at risk EG0010 affected8 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0012 affected8 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0012 affected8 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected6 at risk EG0011 affected8 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0012 affected8 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Dysgeusia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Headache	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected6 at risk EG0013 affected8 at risk
Memory impairment	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Seizure	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Somnolence	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Tremor	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Agitation	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Confusional state	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Depression	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Hallucination	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Insomnia	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0005 affected6 at risk EG0010 affected8 at risk
Mental status changes	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0011 affected8 at risk
Bladder hypertrophy	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Haematuria	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Pollakiuria	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0011 affected8 at risk
Renal failure	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Urinary retention	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Urinary tract pain	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected6 at risk EG0010 affected8 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0004 affected6 at risk EG0010 affected8 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected6 at risk EG0011 affected8 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0011 affected8 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Pulmonary artery wall hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Pulmonary pain	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0012 affected8 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected6 at risk EG0011 affected8 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Embolism	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Hypertension	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0011 affected8 at risk
Hypotension	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D009930	Organic Chemicals
D010649	Phenylalanine
D024322	Amino Acids, Aromatic
D000598	Amino Acids, Cyclic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pre-allo (Before Stem Cell Transplant)	Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine) Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2) Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant	6	6	5	6	6	6
EG001	Post-allo (After Stem Cell Transplant)	Post-allo vadastuximab talirine vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle	2	8	2	8	8	8

ID	Term
C024352	fludarabine
D008558	Melphalan
C000631166	vadastuximab talirine