NCT01453088 · ADVERSE EVENTS

Adverse events

Auto Transplant High Dose Melphalan vs High Dose Melphalan+Bortezomib in Pts With Multiple Myeloma Age 65 Years or Older · Source last updated 2026-03-24

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: 3 Years Post Transplant
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Auto Transplant High Dose Melphalan Melphalan is administered at a dose of 200mg/m2 by rapid intravenous infusion via a central or peripheral vein over 30 minutes to one hour. Melphalan will be given as a single dose (not split over 2 or more days) and given on day-1. Dosing will be based on body surface area calculated using actual body weight	13 / 28	0 / 28	1 / 28
Auto Transplant High Dose Melphalan+Bortezomib Bortezomib: Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at least 20 hrs after the start of the melphalan infusion on day -1. Bortezomib: Bortezomib: Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at least 20 hrs after the start of the melphalan infusion on day -1.	18 / 31	0 / 31	4 / 31

Group identifiers: EG000: Auto Transplant High Dose Melphalan · EG001: Auto Transplant High Dose Melphalan+Bortezomib

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
2
num At Risk
28
num Events
2
group Id
EG001
num Affected
0
num At Risk
31
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
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
term
C Diff Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
28
num Events
0
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
term
Cervical Fusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
28
num Events
0
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
28
num Events
0
group Id
EG001
num Affected
2
num At Risk
31
num Events
2
term
Death (Disease Progression)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
28
num Events
0
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
term
Death (Fall)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
28
num Events
3
group Id
EG001
num Affected
11
num At Risk
31
num Events
11
term
Disease Progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
term
Fall/Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
term
Fractured Right Arm
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
28
num Events
0
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
term
Hemolytic Anemia

Other reported adverse events

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

Complete source fields

event Groups

deaths Num Affected
1
deaths Num At Risk
28
description
Melphalan is administered at a dose of 200mg/m2 by rapid intravenous infusion via a central or peripheral vein over 30 minutes to one hour. Melphalan will be given as a single dose (not split over 2 or more days) and given on day-1. Dosing will be based on body surface area calculated using actual body weight
id
EG000
other Num Affected
0
other Num At Risk
28
serious Num Affected
13
serious Num At Risk
28
title
Auto Transplant High Dose Melphalan
deaths Num Affected
4
deaths Num At Risk
31
description
Bortezomib: Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at least 20 hrs after the start of the melphalan infusion on day -1. Bortezomib: Bortezomib: Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at least 20 hrs after the start of the melphalan infusion on day -1.
id
EG001
other Num Affected
0
other Num At Risk
31
serious Num Affected
18
serious Num At Risk
31
title
Auto Transplant High Dose Melphalan+Bortezomib

frequency Threshold

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
group Id
EG001
num Affected
0
num At Risk
31
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
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
term
C Diff Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
28
num Events
0
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
term
Cervical Fusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
28
num Events
0
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
28
num Events
0
group Id
EG001
num Affected
2
num At Risk
31
num Events
2
term
Death (Disease Progression)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
28
num Events
0
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
term
Death (Fall)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
28
num Events
3
group Id
EG001
num Affected
11
num At Risk
31
num Events
11
term
Disease Progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
term
Fall/Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
term
Fractured Right Arm
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
28
num Events
0
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
term
Hemolytic Anemia

time Frame

3 Years Post Transplant

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Preserved source evidence · Not medical advice