NCT01559935 · ADVERSE EVENTS

Adverse events

Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Therapy for Subjects With Multiple Myeloma · Source last updated 2026-08-19

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: Not reported
Other-event reporting threshold: 5%

Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Car-BiRD Therapy Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \[Car-BiRD\] Car Phase: carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib. BiRD Phase: Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Maintenance Phase: Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.	26 / 72	72 / 72	1 / 72

Group identifiers: EG000: Car-BiRD Therapy

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
notes
car phase
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
72
num Events
2
term
dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
car phase
organ System
Vascular disorders
stats
group Id
EG000
num Affected
2
num At Risk
72
num Events
3
term
fever
assessment Type
SYSTEMATIC_ASSESSMENT
notes
car phase
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
72
num Events
2
term
abnominal infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
car phase
organ System
Infections and infestations
stats
group Id
EG000
num Affected
3
num At Risk
72
num Events
4
term
lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
car phase
organ System
Infections and infestations
stats
group Id
EG000
num Affected
2
num At Risk
72
num Events
2
term
URI
assessment Type
SYSTEMATIC_ASSESSMENT
notes
car phase
organ System
Infections and infestations
stats
group Id
EG000
num Affected
2
num At Risk
72
num Events
2
term
UTI
assessment Type
SYSTEMATIC_ASSESSMENT
notes
car phase
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
72
num Events
1
term
femur fracture
assessment Type
SYSTEMATIC_ASSESSMENT
notes
car phase
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
72
num Events
1
term
spinal fracture
assessment Type
SYSTEMATIC_ASSESSMENT
notes
car phase
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
72
num Events
1
term
atrial fibrilation
assessment Type
SYSTEMATIC_ASSESSMENT
notes
car phase
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
72
num Events
1
term
massive heart attack
assessment Type
SYSTEMATIC_ASSESSMENT
notes
car phase
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
72
num Events
1
term
syncope
assessment Type
SYSTEMATIC_ASSESSMENT
notes
car phase
organ System
Injury, poisoning and procedural complications
stats
group Id
EG000
num Affected
1
num At Risk
72
num Events
1
term
fall

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
notes
Car phase
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
52
num At Risk
72
term
anemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Car phase
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
64
num At Risk
72
term
thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Car phase
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
13
num At Risk
72
term
neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Car phase
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
25
num At Risk
72
term
leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Car phase
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
69
num At Risk
72
term
lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Car phase
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
13
num At Risk
72
term
dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Car phase
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
18
num At Risk
72
term
constipation
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Car phase
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
17
num At Risk
72
term
nausea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Car phase
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
6
num At Risk
72
term
anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Car phase
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
25
num At Risk
72
term
diarhhea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Car phase
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
8
num At Risk
72
term
vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Car phase
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
7
num At Risk
72
term
flatulance

Complete source fields

description

event Groups

deaths Num Affected
1
deaths Num At Risk
72
description
Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \[Car-BiRD\] Car Phase: carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib. BiRD Phase: Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Maintenance Phase: Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
id
EG000
other Num Affected
72
other Num At Risk
72
serious Num Affected
26
serious Num At Risk
72
title
Car-BiRD Therapy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Car phase
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
52
num At Risk
72
term
anemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Car phase
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
64
num At Risk
72
term
thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Car phase
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
13
num At Risk
72
term
neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Car phase
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
25
num At Risk
72
term
leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Car phase
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
69
num At Risk
72
term
lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Car phase
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
13
num At Risk
72
term
dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Car phase
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
18
num At Risk
72
term
constipation
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Car phase
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
17
num At Risk
72
term
nausea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Car phase
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
6
num At Risk
72
term
anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Car phase
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
25
num At Risk
72
term
diarhhea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Car phase
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
8
num At Risk
72
term
vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Car phase
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
7
num At Risk
72
term
flatulance

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
car phase
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
72
num Events
2
term
dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
car phase
organ System
Vascular disorders
stats
group Id
EG000
num Affected
2
num At Risk
72
num Events
3
term
fever
assessment Type
SYSTEMATIC_ASSESSMENT
notes
car phase
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
72
num Events
2
term
abnominal infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
car phase
organ System
Infections and infestations
stats
group Id
EG000
num Affected
3
num At Risk
72
num Events
4
term
lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
car phase
organ System
Infections and infestations
stats
group Id
EG000
num Affected
2
num At Risk
72
num Events
2
term
URI
assessment Type
SYSTEMATIC_ASSESSMENT
notes
car phase
organ System
Infections and infestations
stats
group Id
EG000
num Affected
2
num At Risk
72
num Events
2
term
UTI
assessment Type
SYSTEMATIC_ASSESSMENT
notes
car phase
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
72
num Events
1
term
femur fracture
assessment Type
SYSTEMATIC_ASSESSMENT
notes
car phase
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
72
num Events
1
term
spinal fracture
assessment Type
SYSTEMATIC_ASSESSMENT
notes
car phase
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
72
num Events
1
term
atrial fibrilation
assessment Type
SYSTEMATIC_ASSESSMENT
notes
car phase
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
72
num Events
1
term
massive heart attack
assessment Type
SYSTEMATIC_ASSESSMENT
notes
car phase
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
72
num Events
1
term
syncope
assessment Type
SYSTEMATIC_ASSESSMENT
notes
car phase
organ System
Injury, poisoning and procedural complications
stats
group Id
EG000
num Affected
1
num At Risk
72
num Events
1
term
fall

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

Preserved source evidence · Not medical advice