NCT03417284 · ADVERSE EVENTS

Adverse events

Melphalan Hydrochloride in Treating Participants With Newly-Diagnosed Multiple Myeloma Undergoing Donor Stem Cell Transplantation · Source last updated 2025-05-01

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: Up to one year
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Group1_Dose 1 200mgm2 PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV	0 / 4	3 / 4	1 / 4
Group 1_Dose 2 225mgm2 PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV	0 / 27	27 / 27	0 / 27
Group 2_Dose 1 200mgm2 PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV	0 / 4	4 / 4	0 / 4
Group 2_Dose 225mgm2 PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV	0 / 27	27 / 27	0 / 27

Group identifiers: EG000: Group1_Dose 1 200mgm2 · EG001: Group 1_Dose 2 225mgm2 · EG002: Group 2_Dose 1 200mgm2 · EG003: Group 2_Dose 225mgm2

Serious adverse events

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

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 (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
27
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
8
num At Risk
27
num Events
8
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
8
num At Risk
27
num Events
8
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
27
num Events
1
term
ALK increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
5
num At Risk
27
num Events
5
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
5
num At Risk
27
num Events
5
term
ALT increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
5
num At Risk
27
num Events
5
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
5
num At Risk
27
num Events
5
term
AST increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
3
num At Risk
27
num Events
3
term
Bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
27
num Events
0
term
Cystitis noninfective
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
4
num Events
3
group Id
EG001
num Affected
25
num At Risk
27
num Events
25
group Id
EG002
num Affected
3
num At Risk
4
num Events
3
group Id
EG003
num Affected
25
num At Risk
27
num Events
25
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
27
num Events
1
term
Dysgeusia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
2
num At Risk
27
num Events
2
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
3
num At Risk
27
num Events
3
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
27
num Events
1
term
Dysrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
27
num Events
0
term
Edema

Complete source fields

event Groups

deaths Num Affected
1
deaths Num At Risk
4
description
PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
id
EG000
other Num Affected
3
other Num At Risk
4
serious Num Affected
0
serious Num At Risk
4
title
Group1_Dose 1 200mgm2
deaths Num Affected
0
deaths Num At Risk
27
description
PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
id
EG001
other Num Affected
27
other Num At Risk
27
serious Num Affected
0
serious Num At Risk
27
title
Group 1_Dose 2 225mgm2
deaths Num Affected
0
deaths Num At Risk
4
description
PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
id
EG002
other Num Affected
4
other Num At Risk
4
serious Num Affected
0
serious Num At Risk
4
title
Group 2_Dose 1 200mgm2
deaths Num Affected
0
deaths Num At Risk
27
description
PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
id
EG003
other Num Affected
27
other Num At Risk
27
serious Num Affected
0
serious Num At Risk
27
title
Group 2_Dose 225mgm2

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
27
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
8
num At Risk
27
num Events
8
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
8
num At Risk
27
num Events
8
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
27
num Events
1
term
ALK increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
5
num At Risk
27
num Events
5
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
5
num At Risk
27
num Events
5
term
ALT increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
5
num At Risk
27
num Events
5
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
5
num At Risk
27
num Events
5
term
AST increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
3
num At Risk
27
num Events
3
term
Bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
27
num Events
0
term
Cystitis noninfective
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
4
num Events
3
group Id
EG001
num Affected
25
num At Risk
27
num Events
25
group Id
EG002
num Affected
3
num At Risk
4
num Events
3
group Id
EG003
num Affected
25
num At Risk
27
num Events
25
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
27
num Events
1
term
Dysgeusia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
2
num At Risk
27
num Events
2
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
3
num At Risk
27
num Events
3
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
27
num Events
1
term
Dysrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
27
num Events
0
term
Edema

time Frame

Up to one year

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

Preserved source evidence · Not medical advice