NCT01745588 · ADVERSE EVENTS

Adverse events

Autologous Stem Cell Transplant With Pomalidomide (CC-4047®) Maintenance Versus Continuous Clarithromycin/ Pomalidomide / Dexamethasone Salvage Therapy in Relapsed or Refractory Multiple Myeloma · Source last updated 2026-09-25

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 118 months
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Clarithromycin + Pomalidomide + Dexamethasone + Stem Cell All patients will receive 4 cycles of clarithromycin 500mg twice daily on days 1-28, pomalidomide 4 mg daily on days 1 through 21 and dexamethasone orally at a dose of 40 mg daily on days 1, 8, 15, and 22 of each 28-day cycle. Patients randomized to auto-SCT will proceed within 28 days after completion of the 4th cycle of ClaPD to receive melphalan 140mg/m2 or 200mg/m2 (as per institutional guidelines) followed by hematopoietic cell infusion. Pomalidomide stem cell Clarithromycin	5 / 12	8 / 12	8 / 12
Clarithromycin + Pomalidomide + Dexamethasone Alone All patients will receive 4 cycles of clarithromycin 500mg twice daily on days 1-28 pomalidomide 4 mg daily on days 1 through 21 and dexamethasone orally at a dose of 40 mg daily on days 1, 8, 15, and 22 of each 28 day cycle. Patients assigned to ClaPD alone will receive 5 additional cycles of ClaPD. Pomalidomide Dexamethasone Clarithromycin	5 / 11	6 / 11	8 / 11

Group identifiers: EG000: Clarithromycin + Pomalidomide + Dexamethasone + Stem Cell · EG001: Clarithromycin + Pomalidomide + Dexamethasone Alone

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
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
11
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
11
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
11
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
11
term
Localized Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
11
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
11
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
3
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
11
term
Mucosal Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
11
term
Hip fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Hyperglycemia

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
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
12
group Id
EG001
num Affected
2
num At Risk
11
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
2
num At Risk
11
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
ALT increase
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
2
num At Risk
12
group Id
EG001
num Affected
4
num At Risk
11
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
2
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Aspartate aminotransferase increased

Complete source fields

event Groups

deaths Num Affected
8
deaths Num At Risk
12
description
All patients will receive 4 cycles of clarithromycin 500mg twice daily on days 1-28, pomalidomide 4 mg daily on days 1 through 21 and dexamethasone orally at a dose of 40 mg daily on days 1, 8, 15, and 22 of each 28-day cycle. Patients randomized to auto-SCT will proceed within 28 days after completion of the 4th cycle of ClaPD to receive melphalan 140mg/m2 or 200mg/m2 (as per institutional guidelines) followed by hematopoietic cell infusion. Pomalidomide stem cell Clarithromycin
id
EG000
other Num Affected
8
other Num At Risk
12
serious Num Affected
5
serious Num At Risk
12
title
Clarithromycin + Pomalidomide + Dexamethasone + Stem Cell
deaths Num Affected
8
deaths Num At Risk
11
description
All patients will receive 4 cycles of clarithromycin 500mg twice daily on days 1-28 pomalidomide 4 mg daily on days 1 through 21 and dexamethasone orally at a dose of 40 mg daily on days 1, 8, 15, and 22 of each 28 day cycle. Patients assigned to ClaPD alone will receive 5 additional cycles of ClaPD. Pomalidomide Dexamethasone Clarithromycin
id
EG001
other Num Affected
6
other Num At Risk
11
serious Num Affected
5
serious Num At Risk
11
title
Clarithromycin + Pomalidomide + Dexamethasone Alone

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
12
group Id
EG001
num Affected
2
num At Risk
11
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
2
num At Risk
11
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
ALT increase
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
2
num At Risk
12
group Id
EG001
num Affected
4
num At Risk
11
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
2
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Aspartate aminotransferase increased

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
11
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
11
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
11
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
11
term
Localized Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
11
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
11
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
3
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
11
term
Mucosal Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
11
term
Hip fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
11
term
Hyperglycemia

time Frame

up to 118 months

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Preserved source evidence · Not medical advice