Trial Outcomes & Findings for A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy (NCT NCT00833560)
NCT ID: NCT00833560
Last Updated: 2014-11-21
Results Overview
CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
401 participants
Primary outcome timeframe
Up to Day 63
Results posted on
2014-11-21
Participant Flow
401 participants were enrolled at 41 study sites in Germany.
Out of 401 participants, 399 participants were treated in both the Parts. Out of 399 participants, 395 participants were evaluated as 4 participants who had received cyclophophamide dose of greater than 1350 mg/m\^2 per cycle in Part 1 were excluded.
Participant milestones
| Measure |
Cyclophosphamide + Bortezomib + Dexamethasone
Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
|
|---|---|
|
Overall Study
STARTED
|
395
|
|
Overall Study
COMPLETED
|
353
|
|
Overall Study
NOT COMPLETED
|
42
|
Reasons for withdrawal
| Measure |
Cyclophosphamide + Bortezomib + Dexamethasone
Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
|
|---|---|
|
Overall Study
Toxicity
|
13
|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
Protocol Violation
|
6
|
|
Overall Study
Lack of Efficacy
|
4
|
|
Overall Study
Death
|
2
|
|
Overall Study
Pregression of other disease
|
1
|
|
Overall Study
Other
|
5
|
Baseline Characteristics
A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy
Baseline characteristics by cohort
| Measure |
Cyclophosphamide + Bortezomib + Dexamethasone
n=395 Participants
Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
|
|---|---|
|
Age, Continuous
|
52.4 Years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Age, Customized
Between 20 and 39 years
|
17 Participants
n=5 Participants
|
|
Age, Customized
Between 40 and 49 years
|
109 Participants
n=5 Participants
|
|
Age, Customized
Between 50 and 60 years
|
253 Participants
n=5 Participants
|
|
Age, Customized
>65 years
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
166 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
229 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 63Population: Efficacy analysis set: Participants of the safety analysis set (who received bortezomib at least once independently of accordance to the protocol) who had an evaluable investigator based assessment of success of therapy at the end of study visit (ie, assessment by local investigator as CR, PR, minimal response, stable disease, progressive disease).
CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.
Outcome measures
| Measure |
Cyclophosphamide + Bortezomib + Dexamethasone
n=391 Participants
Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
|
|---|---|
|
Participants With Complete Response (CR) + Partial Response (PR) (Efficacy Set)
|
334 Participants
|
SECONDARY outcome
Timeframe: Up to Day 63Population: Per-protocol analysis set: It includes the participants who completed the entire clinical study without major protocol violations.
CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.
Outcome measures
| Measure |
Cyclophosphamide + Bortezomib + Dexamethasone
n=324 Participants
Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
|
|---|---|
|
Participants With Complete Response (CR) + Partial Response (PR) (Per-protocol Analysis Set)
|
284 Participants
|
SECONDARY outcome
Timeframe: Up to Day 63Population: Efficacy analysis set. N (number of participants analyzed) signifies participants with complete or partial response. "n" signifies number of participants who were evaluable for each specified category (participants that carried the indicated cytogenetic marker).
Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible
Outcome measures
| Measure |
Cyclophosphamide + Bortezomib + Dexamethasone
n=334 Participants
Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
|
|---|---|
|
Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set)
13q- (n=112)
|
90.2 Percentage of participants
|
|
Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set)
t (4;14) (n=38)
|
89.5 Percentage of participants
|
|
Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set)
17p- (n=31)
|
74.2 Percentage of participants
|
|
Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set)
Other (n=104)
|
87.5 Percentage of participants
|
|
Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set)
No changes (n=102)
|
84.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 63Population: Per-protocol analysis set. N (number of participants analyzed) signifies participants with complete or partial response. "n" signifies number of participants who were evaluable for each specified category (participants that carried the indicated cytogenetic marker).
Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible.
Outcome measures
| Measure |
Cyclophosphamide + Bortezomib + Dexamethasone
n=284 Participants
Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
|
|---|---|
|
Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Per-protocol Set)
13q- (n=92)
|
92.4 Percentage of participants
|
|
Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Per-protocol Set)
t (4;14) (n=34)
|
91.2 Percentage of participants
|
|
Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Per-protocol Set)
17p- (n=24)
|
87.5 Percentage of participants
|
|
Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Per-protocol Set)
Other (n=87)
|
88.5 Percentage of participants
|
|
Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Per-protocol Set)
No changes (n=87)
|
85.1 Percentage of participants
|
Adverse Events
Cyclophosphamide + Bortezomib + Dexamethasone
Serious events: 103 serious events
Other events: 392 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cyclophosphamide + Bortezomib + Dexamethasone
n=395 participants at risk
Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
|
|---|---|
|
Infections and infestations
Pneumonia
|
3.8%
15/395 • Number of events 16 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Infections and infestations
Herpes zoster
|
0.76%
3/395 • Number of events 3 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Infections and infestations
Sepsis
|
0.76%
3/395 • Number of events 3 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Infections and infestations
Urinary tract infection
|
0.76%
3/395 • Number of events 3 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Infections and infestations
Bronchitis
|
0.51%
2/395 • Number of events 2 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Infections and infestations
Bacterial sepsis
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Infections and infestations
Bronchiolitis
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Infections and infestations
Bronchitis bacterial
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Infections and infestations
Bronchopneumonia
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Infections and infestations
Device related infection
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Infections and infestations
Encephalitis herpes
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Infections and infestations
Endocarditis bacterial
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Infections and infestations
Erysipelas
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Infections and infestations
Febrile infection
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Infections and infestations
Gastroenteritis
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Infections and infestations
Gastroenteritis adenovirus
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Infections and infestations
Herpes simplex
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Infections and infestations
Herpes virus infection
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Infections and infestations
Septic shock
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Infections and infestations
Pneumonia viral
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
General disorders
Pyrexia
|
3.5%
14/395 • Number of events 15 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
General disorders
Disease progression
|
0.76%
3/395 • Number of events 3 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
General disorders
Asthenia
|
0.51%
2/395 • Number of events 2 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
General disorders
General physical health deterioration
|
0.51%
2/395 • Number of events 2 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
General disorders
Pain
|
0.51%
2/395 • Number of events 2 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
General disorders
Chills
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
General disorders
Fatigue
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
General disorders
Multi-organ failure
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
General disorders
Sudden cardiac death
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.8%
11/395 • Number of events 12 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.0%
4/395 • Number of events 5 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.76%
3/395 • Number of events 3 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Blood and lymphatic system disorders
Hyperviscosity syndrome
|
0.51%
2/395 • Number of events 2 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
5/395 • Number of events 5 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Gastrointestinal disorders
Constipation
|
1.0%
4/395 • Number of events 4 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Gastrointestinal disorders
Nausea
|
1.0%
4/395 • Number of events 5 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Gastrointestinal disorders
Vomiting
|
0.76%
3/395 • Number of events 3 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.51%
2/395 • Number of events 2 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Gastrointestinal disorders
Anal fissure
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Gastrointestinal disorders
Flatulence
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Gastrointestinal disorders
Ileus
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Gastrointestinal disorders
Intestinal dilatation
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Gastrointestinal disorders
Periodontitis
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Nervous system disorders
Polyneuropathy
|
1.0%
4/395 • Number of events 4 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Nervous system disorders
Convulsion
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Nervous system disorders
Dizziness
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Nervous system disorders
Loss of consciousness
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Nervous system disorders
Neuralgia
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Nervous system disorders
Paraparesis
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Investigations
C-reactive protein increased
|
0.51%
2/395 • Number of events 2 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Investigations
Alanine aminotransferase increased
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Investigations
Aspartate aminotransferase increased
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Investigations
Blood creatinine increased
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Investigations
Blood glucose increased
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Investigations
Blood immunoglobulin G increased
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Investigations
Blood potassium increased
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Investigations
Body temperature increased
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.51%
2/395 • Number of events 2 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Cardiac disorders
Cardiac failure
|
1.0%
4/395 • Number of events 4 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Cardiac disorders
Cardiac failure acute
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis allergic
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.25%
1/395 • Number of events 2 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottic oedema
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Ear and labyrinth disorders
Vertigo
|
0.51%
2/395 • Number of events 2 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Ear and labyrinth disorders
Presbyacusis
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Renal and urinary disorders
Renal failure
|
0.76%
3/395 • Number of events 3 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Renal and urinary disorders
Haematuria
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Hepatobiliary disorders
Hepatitis
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.51%
2/395 • Number of events 2 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Vascular disorders
Hypertensive crisis
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Vascular disorders
Hypotension
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Vascular disorders
Thrombosis
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Psychiatric disorders
Anxiety
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Psychiatric disorders
Suicide attempt
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Eye disorders
Diplopia
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.25%
1/395 • Number of events 1 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
Other adverse events
| Measure |
Cyclophosphamide + Bortezomib + Dexamethasone
n=395 participants at risk
Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
|
|---|---|
|
General disorders
Oedema peripheral
|
20.0%
79/395 • Number of events 105 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
General disorders
Fatigue
|
19.2%
76/395 • Number of events 85 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
General disorders
Pyrexia
|
14.2%
56/395 • Number of events 70 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
General disorders
Asthenia
|
10.4%
41/395 • Number of events 46 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
General disorders
Oedema
|
7.1%
28/395 • Number of events 32 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
General disorders
Pain
|
7.1%
28/395 • Number of events 33 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Nervous system disorders
Paraesthesia
|
15.9%
63/395 • Number of events 75 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Nervous system disorders
Headache
|
13.7%
54/395 • Number of events 62 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Nervous system disorders
Polyneuropathy
|
12.9%
51/395 • Number of events 68 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Nervous system disorders
Dizziness
|
12.2%
48/395 • Number of events 55 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Nervous system disorders
Hypoaesthesia
|
6.8%
27/395 • Number of events 30 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Nervous system disorders
Dysgeusia
|
5.1%
20/395 • Number of events 20 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Infections and infestations
Nasopharyngitis
|
11.9%
47/395 • Number of events 50 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Infections and infestations
Rhinitis
|
7.6%
30/395 • Number of events 31 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Investigations
C-reactive protein increased
|
9.9%
39/395 • Number of events 47 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Investigations
Weight increased
|
9.6%
38/395 • Number of events 43 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Investigations
Haemoglobin decreased
|
7.1%
28/395 • Number of events 73 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Investigations
Alanine aminotransferase increased
|
5.6%
22/395 • Number of events 24 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.6%
46/395 • Number of events 56 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.1%
32/395 • Number of events 34 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.3%
29/395 • Number of events 38 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
9.1%
36/395 • Number of events 39 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.1%
28/395 • Number of events 31 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
22/395 • Number of events 22 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.4%
45/395 • Number of events 49 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
28/395 • Number of events 31 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.1%
20/395 • Number of events 21 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Psychiatric disorders
Sleep disorder
|
11.6%
46/395 • Number of events 53 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.3%
25/395 • Number of events 30 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.8%
23/395 • Number of events 27 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Vascular disorders
Hypertension
|
7.1%
28/395 • Number of events 33 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Blood and lymphatic system disorders
Leukopenia
|
53.4%
211/395 • Number of events 680 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
32.7%
129/395 • Number of events 277 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Blood and lymphatic system disorders
Anaemia
|
19.5%
77/395 • Number of events 132 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.1%
32/395 • Number of events 53 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Gastrointestinal disorders
Nausea
|
26.6%
105/395 • Number of events 141 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Gastrointestinal disorders
Constipation
|
21.8%
86/395 • Number of events 98 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.5%
73/395 • Number of events 88 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Gastrointestinal disorders
Vomiting
|
12.7%
50/395 • Number of events 63 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
|
Gastrointestinal disorders
Flatulence
|
6.3%
25/395 • Number of events 26 • From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
|
Additional Information
Therapeutic Areas Director
Jan-Cil Germany
Phone: +49 2137 955-492
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60