NCT02506959 · ADVERSE EVENTS

Adverse events

Panobinostat, Gemcitabine Hydrochloride, Busulfan, and Melphalan Before Stem Cell Transplant in Treating Patients With Refractory or Relapsed Multiple Myeloma · Source last updated 2025-03-18

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 2 years
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant Busulfan: Given IV Gemcitabine Hydrochloride: Given IV Melphalan: Given IV Panobinostat: Given PO Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant Pharmacological Study: Correlative studies	2 / 50	47 / 50	23 / 50
Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant Busulfan: Given IV Gemcitabine Hydrochloride: Given IV Melphalan: Given IV Panobinostat: Given PO Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant Pharmacological Study: Correlative studies	4 / 33	30 / 33	17 / 33

Group identifiers: EG000: Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel · EG001: Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel

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
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
50
num Events
0
group Id
EG001
num Affected
1
num At Risk
33
num Events
1
term
AST increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
33
num Events
0
term
Bleeding (no GI no PUL)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
50
num Events
0
group Id
EG001
num Affected
1
num At Risk
33
num Events
1
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
33
num Events
0
term
DAH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
50
num Events
0
group Id
EG001
num Affected
1
num At Risk
33
num Events
1
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
50
num Events
0
group Id
EG001
num Affected
1
num At Risk
33
num Events
1
term
Encephalopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
2
num At Risk
33
num Events
2
term
Fungal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
50
num Events
0
group Id
EG001
num Affected
1
num At Risk
33
num Events
1
term
Oral mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
33
num Events
0
term
Pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
50
num Events
2
group Id
EG001
num Affected
0
num At Risk
33
num Events
0
term
Pulmonary edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
50
num Events
0
group Id
EG001
num Affected
1
num At Risk
33
num Events
1
term
T bilirubin 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
50
num Events
1
group Id
EG001
num Affected
4
num At Risk
33
num Events
4
term
Viral

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
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
2
num At Risk
33
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
50
num Events
2
group Id
EG001
num Affected
3
num At Risk
33
num Events
3
term
ALK increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
1
num At Risk
33
num Events
1
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
25
num At Risk
50
num Events
25
group Id
EG001
num Affected
20
num At Risk
33
num Events
20
term
ALT increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
50
num Events
0
group Id
EG001
num Affected
1
num At Risk
33
num Events
1
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
10
num At Risk
50
num Events
10
group Id
EG001
num Affected
6
num At Risk
33
num Events
6
term
AST increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
18
num At Risk
50
num Events
18
group Id
EG001
num Affected
14
num At Risk
33
num Events
14
term
Bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
33
num Events
0
term
Bleeding (no GI no PUL)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
50
num Events
0
group Id
EG001
num Affected
1
num At Risk
33
num Events
1
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
33
num Events
0
term
CD OTH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
1
num At Risk
33
num Events
1
term
Confusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
50
num Events
0
group Id
EG001
num Affected
1
num At Risk
33
num Events
1
term
Cough

Complete source fields

event Groups

deaths Num Affected
23
deaths Num At Risk
50
description
Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant Busulfan: Given IV Gemcitabine Hydrochloride: Given IV Melphalan: Given IV Panobinostat: Given PO Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant Pharmacological Study: Correlative studies
id
EG000
other Num Affected
47
other Num At Risk
50
serious Num Affected
2
serious Num At Risk
50
title
Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
deaths Num Affected
17
deaths Num At Risk
33
description
Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant Busulfan: Given IV Gemcitabine Hydrochloride: Given IV Melphalan: Given IV Panobinostat: Given PO Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant Pharmacological Study: Correlative studies
id
EG001
other Num Affected
30
other Num At Risk
33
serious Num Affected
4
serious Num At Risk
33
title
Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
2
num At Risk
33
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
50
num Events
2
group Id
EG001
num Affected
3
num At Risk
33
num Events
3
term
ALK increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
1
num At Risk
33
num Events
1
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
25
num At Risk
50
num Events
25
group Id
EG001
num Affected
20
num At Risk
33
num Events
20
term
ALT increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
50
num Events
0
group Id
EG001
num Affected
1
num At Risk
33
num Events
1
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
10
num At Risk
50
num Events
10
group Id
EG001
num Affected
6
num At Risk
33
num Events
6
term
AST increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
18
num At Risk
50
num Events
18
group Id
EG001
num Affected
14
num At Risk
33
num Events
14
term
Bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
33
num Events
0
term
Bleeding (no GI no PUL)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
50
num Events
0
group Id
EG001
num Affected
1
num At Risk
33
num Events
1
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
33
num Events
0
term
CD OTH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
1
num At Risk
33
num Events
1
term
Confusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
50
num Events
0
group Id
EG001
num Affected
1
num At Risk
33
num Events
1
term
Cough

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
50
num Events
0
group Id
EG001
num Affected
1
num At Risk
33
num Events
1
term
AST increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
33
num Events
0
term
Bleeding (no GI no PUL)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
50
num Events
0
group Id
EG001
num Affected
1
num At Risk
33
num Events
1
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
33
num Events
0
term
DAH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
50
num Events
0
group Id
EG001
num Affected
1
num At Risk
33
num Events
1
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
50
num Events
0
group Id
EG001
num Affected
1
num At Risk
33
num Events
1
term
Encephalopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
2
num At Risk
33
num Events
2
term
Fungal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
50
num Events
0
group Id
EG001
num Affected
1
num At Risk
33
num Events
1
term
Oral mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
33
num Events
0
term
Pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
50
num Events
2
group Id
EG001
num Affected
0
num At Risk
33
num Events
0
term
Pulmonary edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
50
num Events
0
group Id
EG001
num Affected
1
num At Risk
33
num Events
1
term
T bilirubin 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
50
num Events
1
group Id
EG001
num Affected
4
num At Risk
33
num Events
4
term
Viral

time Frame

Up to 2 years

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

Preserved source evidence · Not medical advice