NCT04205240 · ADVERSE EVENTS

Adverse events

Reduce Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed Multiple Myeloma · Source last updated 2023-09-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Adverse event information was collected for patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion up to 1 year.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Conditioning Regimen, Stem Cell Transplant) Patients receive fludarabine IV on days -5 to -2 and melphalan IV on days -3 to -2, then undergo stem cell transplantation on day 0. Patients receive cyclophosphamide on days 3 and 4, tacrolimus PO BID or IV starting on day 5, and mycophenolate mofetil IV or PO TID on days 5 to 35. Patients also receive daratumumab IV starting between days 90-150 for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplantation Cyclophosphamide: Given IV Daratumumab: Given IV Fludarabine: Given IV Melphalan: Given IV Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given PO or IV	1 / 1	1 / 1	1 / 1

Group identifiers: EG000: Treatment (Conditioning Regimen, Stem Cell Transplant)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Metabolism and Nutrition Disorders
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
3
term
Respiratory Failure

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Abdominal Distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Acidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Adult respiratory distress syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Alkalosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Anxiety

Complete source fields

event Groups

deaths Num Affected
1
deaths Num At Risk
1
description
Patients receive fludarabine IV on days -5 to -2 and melphalan IV on days -3 to -2, then undergo stem cell transplantation on day 0. Patients receive cyclophosphamide on days 3 and 4, tacrolimus PO BID or IV starting on day 5, and mycophenolate mofetil IV or PO TID on days 5 to 35. Patients also receive daratumumab IV starting between days 90-150 for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplantation Cyclophosphamide: Given IV Daratumumab: Given IV Fludarabine: Given IV Melphalan: Given IV Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given PO or IV
id
EG000
other Num Affected
1
other Num At Risk
1
serious Num Affected
1
serious Num At Risk
1
title
Treatment (Conditioning Regimen, Stem Cell Transplant)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Abdominal Distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Acidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Adult respiratory distress syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Alkalosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Anxiety

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Metabolism and Nutrition Disorders
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE version 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
3
term
Respiratory Failure

time Frame

Adverse event information was collected for patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion up to 1 year.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice