NCT01056276 · ADVERSE EVENTS

Adverse events

Study to Evaluate the Combination of Bendamustine, Bortezomib and Dexamethasone (BBD) in the First-Line Treatment of Patients With Multiple Myeloma Who Are Not Candidates for High Dose Chemotherapy · Source last updated 2017-05-03

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: every 4 weeks for up to 32 weeks on the Original BBD Regimen, or up to 2 years on the Modified BBD Regimen
Other-event reporting threshold: 5%

All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Original BBD Regimen Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy. Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4	7 / 18	18 / 18	Not reported / Not reported
Modified BBD Regimen Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion. Treatment: Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16 Maintenance: Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15	17 / 41	38 / 41	Not reported / Not reported

Group identifiers: EG000: Original BBD Regimen · EG001: Modified BBD Regimen

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
41
num Events
1
term
Amyloidosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
41
num Events
1
term
Angina pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
41
num Events
1
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
41
num Events
1
term
Bacteraemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
2
num At Risk
41
num Events
2
term
Cardiac arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
group Id
EG001
num Affected
1
num At Risk
41
num Events
1
term
Cardiac failure congestive
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
group Id
EG001
num Affected
0
num At Risk
41
num Events
0
term
Confusional state
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
41
num Events
1
term
Disease progression
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
41
num Events
1
term
Diverticulum
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
41
num Events
1
term
Embolism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
group Id
EG001
num Affected
0
num At Risk
41
num Events
0
term
Fall
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
group Id
EG001
num Affected
1
num At Risk
41
num Events
1
term
Febrile neutropenia

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
General disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
13
num At Risk
18
group Id
EG001
num Affected
31
num At Risk
41
term
FATIGUE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
13
num At Risk
18
group Id
EG001
num Affected
28
num At Risk
41
term
PERIPHERAL NEUROPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
7
num At Risk
18
group Id
EG001
num Affected
23
num At Risk
41
term
ANEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
6
num At Risk
18
group Id
EG001
num Affected
21
num At Risk
41
term
EDEMA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
0
num At Risk
18
group Id
EG001
num Affected
18
num At Risk
41
term
BACK PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
9
num At Risk
18
group Id
EG001
num Affected
18
num At Risk
41
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
9
num At Risk
18
group Id
EG001
num Affected
18
num At Risk
41
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
6
num At Risk
18
group Id
EG001
num Affected
17
num At Risk
41
term
INSOMNIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
2
num At Risk
18
group Id
EG001
num Affected
15
num At Risk
41
term
COUGH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
5
num At Risk
18
group Id
EG001
num Affected
15
num At Risk
41
term
DIARRHEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
6
num At Risk
18
group Id
EG001
num Affected
15
num At Risk
41
term
ARTHRALGIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
7
num At Risk
18
group Id
EG001
num Affected
14
num At Risk
41
term
NEUTROPENIA

Complete source fields

description

event Groups

description
Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy. Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4
id
EG000
other Num Affected
18
other Num At Risk
18
serious Num Affected
7
serious Num At Risk
18
title
Original BBD Regimen
description
Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion. Treatment: Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16 Maintenance: Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15
id
EG001
other Num Affected
38
other Num At Risk
41
serious Num Affected
17
serious Num At Risk
41
title
Modified BBD Regimen

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
13
num At Risk
18
group Id
EG001
num Affected
31
num At Risk
41
term
FATIGUE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
13
num At Risk
18
group Id
EG001
num Affected
28
num At Risk
41
term
PERIPHERAL NEUROPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
7
num At Risk
18
group Id
EG001
num Affected
23
num At Risk
41
term
ANEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
6
num At Risk
18
group Id
EG001
num Affected
21
num At Risk
41
term
EDEMA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
0
num At Risk
18
group Id
EG001
num Affected
18
num At Risk
41
term
BACK PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
9
num At Risk
18
group Id
EG001
num Affected
18
num At Risk
41
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
9
num At Risk
18
group Id
EG001
num Affected
18
num At Risk
41
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
6
num At Risk
18
group Id
EG001
num Affected
17
num At Risk
41
term
INSOMNIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
2
num At Risk
18
group Id
EG001
num Affected
15
num At Risk
41
term
COUGH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
5
num At Risk
18
group Id
EG001
num Affected
15
num At Risk
41
term
DIARRHEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
6
num At Risk
18
group Id
EG001
num Affected
15
num At Risk
41
term
ARTHRALGIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
7
num At Risk
18
group Id
EG001
num Affected
14
num At Risk
41
term
NEUTROPENIA

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
41
num Events
1
term
Amyloidosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
41
num Events
1
term
Angina pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
41
num Events
1
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
41
num Events
1
term
Bacteraemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
2
num At Risk
41
num Events
2
term
Cardiac arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
group Id
EG001
num Affected
1
num At Risk
41
num Events
1
term
Cardiac failure congestive
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
group Id
EG001
num Affected
0
num At Risk
41
num Events
0
term
Confusional state
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
41
num Events
1
term
Disease progression
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
41
num Events
1
term
Diverticulum
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
41
num Events
1
term
Embolism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
group Id
EG001
num Affected
0
num At Risk
41
num Events
0
term
Fall
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
group Id
EG001
num Affected
1
num At Risk
41
num Events
1
term
Febrile neutropenia

time Frame

every 4 weeks for up to 32 weeks on the Original BBD Regimen, or up to 2 years on the Modified BBD Regimen

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

Preserved source evidence · Not medical advice