NCT03187223 · ADVERSE EVENTS

Adverse events

Bendamustine and Melphalan in Myeloma · Source last updated 2025-01-30

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: Deaths were assessed up to 24 months. Adverse Events were assessed through 60 days
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm A (Mel) Melphalan 100mg/m2/day iv days -2 and -1 Melphalan: High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive melphalan at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day on days -2 and -1, with the ASCT at day 0.	9 / 60	36 / 60	0 / 60
Arm B (BenMel) Melphalan 100mg/m2/day iv days -2 and -1 Bendamustine 200mg/m2/day iv days -4 and -3 Melphalan: High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive melphalan at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day on days -2 and -1, with the ASCT at day 0. Bendamustine: High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive bendamustine at a total dose of 400mg/m2, divided in two doses of 200mg/m2/day on days -4 and -3. Melphalan is given at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day, each on days -2 and -1, with the ASCT at day 0.	12 / 60	43 / 60	1 / 60

Group identifiers: EG000: Arm A (Mel) · EG001: Arm B (BenMel)

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
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
term
atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
term
fever unkown origin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
60
num Events
0
group Id
EG001
num Affected
1
num At Risk
60
num Events
1
term
neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
term
weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
term
respiratory failue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
60
num Events
0
group Id
EG001
num Affected
1
num At Risk
60
num Events
1
term
fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
0
num At Risk
60
num Events
0
group Id
EG001
num Affected
1
num At Risk
60
num Events
1
term
renal failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
60
num Events
0
group Id
EG001
num Affected
1
num At Risk
60
num Events
1
term
colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
term
respiratory infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
60
num Events
0
group Id
EG001
num Affected
1
num At Risk
60
num Events
1
term
right ventricular disfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
60
num Events
0
group Id
EG001
num Affected
1
num At Risk
60
num Events
1
term
weakness

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
stats
group Id
EG000
num Affected
31
num At Risk
60
num Events
31
group Id
EG001
num Affected
30
num At Risk
60
num Events
30
term
Gastrointestinal disordes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
10
num At Risk
60
num Events
10
group Id
EG001
num Affected
20
num At Risk
60
num Events
20
term
Metabolic and nutritional disorders
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
5
num At Risk
60
num Events
5
group Id
EG001
num Affected
3
num At Risk
60
num Events
3
term
Cardiac and thromboembolic disorders
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
60
num Events
0
group Id
EG001
num Affected
5
num At Risk
60
num Events
5
term
Weight loss >10%
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
3
num At Risk
60
num Events
3
group Id
EG001
num Affected
2
num At Risk
60
num Events
2
term
Engraftment syndrome

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
60
description
Melphalan 100mg/m2/day iv days -2 and -1 Melphalan: High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive melphalan at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day on days -2 and -1, with the ASCT at day 0.
id
EG000
other Num Affected
36
other Num At Risk
60
serious Num Affected
9
serious Num At Risk
60
title
Arm A (Mel)
deaths Num Affected
1
deaths Num At Risk
60
description
Melphalan 100mg/m2/day iv days -2 and -1 Bendamustine 200mg/m2/day iv days -4 and -3 Melphalan: High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive melphalan at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day on days -2 and -1, with the ASCT at day 0. Bendamustine: High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive bendamustine at a total dose of 400mg/m2, divided in two doses of 200mg/m2/day on days -4 and -3. Melphalan is given at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day, each on days -2 and -1, with the ASCT at day 0.
id
EG001
other Num Affected
43
other Num At Risk
60
serious Num Affected
12
serious Num At Risk
60
title
Arm B (BenMel)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
31
num At Risk
60
num Events
31
group Id
EG001
num Affected
30
num At Risk
60
num Events
30
term
Gastrointestinal disordes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
10
num At Risk
60
num Events
10
group Id
EG001
num Affected
20
num At Risk
60
num Events
20
term
Metabolic and nutritional disorders
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
5
num At Risk
60
num Events
5
group Id
EG001
num Affected
3
num At Risk
60
num Events
3
term
Cardiac and thromboembolic disorders
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
60
num Events
0
group Id
EG001
num Affected
5
num At Risk
60
num Events
5
term
Weight loss >10%
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
3
num At Risk
60
num Events
3
group Id
EG001
num Affected
2
num At Risk
60
num Events
2
term
Engraftment syndrome

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
term
atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
term
fever unkown origin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
60
num Events
0
group Id
EG001
num Affected
1
num At Risk
60
num Events
1
term
neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
term
weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
term
respiratory failue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
60
num Events
0
group Id
EG001
num Affected
1
num At Risk
60
num Events
1
term
fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
0
num At Risk
60
num Events
0
group Id
EG001
num Affected
1
num At Risk
60
num Events
1
term
renal failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
60
num Events
0
group Id
EG001
num Affected
1
num At Risk
60
num Events
1
term
colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
term
respiratory infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
60
num Events
0
group Id
EG001
num Affected
1
num At Risk
60
num Events
1
term
right ventricular disfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
60
num Events
0
group Id
EG001
num Affected
1
num At Risk
60
num Events
1
term
weakness

time Frame

Deaths were assessed up to 24 months. Adverse Events were assessed through 60 days

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Preserved source evidence · Not medical advice