Trial Outcomes & Findings for MMVAR - Velcade: Study of Velcade for the Treatment of Myeloma Patients After Autologous Transplantation (NCT NCT00256776)
NCT ID: NCT00256776
Last Updated: 2021-10-18
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
269 participants
Primary outcome timeframe
3 year
Results posted on
2021-10-18
Participant Flow
FPI 08-Jul-2005 LPI 21-Jun-2010
Participant milestones
| Measure |
Thal + Dex + Velcade
Velcade (Bortezomib)
Thalidomide
Dexamethasone
Allocated to treatment (n=135) Received allocated treatment (n=135)
|
Thal + Dex
Standard treatment
Thalidomide
Dexamethasone
Allocated to treatment (n=134) Received allocated treatment (n=134)
|
|---|---|---|
|
Overall Study
STARTED
|
135
|
134
|
|
Overall Study
COMPLETED
|
52
|
54
|
|
Overall Study
NOT COMPLETED
|
83
|
80
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Thal + Dex + Velcade
n=135 Participants
Velcade (Bortezomib)
Thalidomide
Dexamethasone
Allocated to treatment (n=135) Received allocated treatment (n=135)
|
Thal + Dex
n=134 Participants
Standard treatment
Thalidomide
Dexamethasone
Allocated to treatment (n=134) Received allocated treatment (n=134)
|
Total
n=269 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=135 Participants
|
0 Participants
n=134 Participants
|
0 Participants
n=269 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
105 Participants
n=135 Participants
|
97 Participants
n=134 Participants
|
202 Participants
n=269 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=135 Participants
|
37 Participants
n=134 Participants
|
67 Participants
n=269 Participants
|
|
Age, Continuous
|
60 years
n=135 Participants
|
62.6 years
n=134 Participants
|
61.2 years
n=269 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=135 Participants
|
51 Participants
n=134 Participants
|
100 Participants
n=269 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=135 Participants
|
83 Participants
n=134 Participants
|
169 Participants
n=269 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Austria
|
5 participants
n=135 Participants
|
3 participants
n=134 Participants
|
8 participants
n=269 Participants
|
|
Region of Enrollment
Belgium
|
9 participants
n=135 Participants
|
14 participants
n=134 Participants
|
23 participants
n=269 Participants
|
|
Region of Enrollment
Hungary
|
5 participants
n=135 Participants
|
6 participants
n=134 Participants
|
11 participants
n=269 Participants
|
|
Region of Enrollment
Czechia
|
5 participants
n=135 Participants
|
3 participants
n=134 Participants
|
8 participants
n=269 Participants
|
|
Region of Enrollment
Italy
|
10 participants
n=135 Participants
|
11 participants
n=134 Participants
|
21 participants
n=269 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=135 Participants
|
1 participants
n=134 Participants
|
1 participants
n=269 Participants
|
|
Region of Enrollment
Israel
|
1 participants
n=135 Participants
|
0 participants
n=134 Participants
|
1 participants
n=269 Participants
|
|
Region of Enrollment
France
|
71 participants
n=135 Participants
|
68 participants
n=134 Participants
|
139 participants
n=269 Participants
|
|
Region of Enrollment
Switzerland
|
11 participants
n=135 Participants
|
8 participants
n=134 Participants
|
19 participants
n=269 Participants
|
|
Region of Enrollment
Germany
|
18 participants
n=135 Participants
|
20 participants
n=134 Participants
|
38 participants
n=269 Participants
|
PRIMARY outcome
Timeframe: 3 yearOutcome measures
| Measure |
Thal + Dex + Velcade
n=135 Participants
Velcade (Bortezomib)
Thalidomide
Dexamethasone
|
Thal + Dex
n=134 Participants
Standard treatment
Thalidomide
Dexamethasone
|
|---|---|---|
|
Median Time to Progression (TTP)
|
19.5 months
Interval 16.3 to 22.7
|
13.8 months
Interval 10.0 to 16.4
|
SECONDARY outcome
Timeframe: 3 yearOutcome measures
| Measure |
Thal + Dex + Velcade
n=135 Participants
Velcade (Bortezomib)
Thalidomide
Dexamethasone
|
Thal + Dex
n=134 Participants
Standard treatment
Thalidomide
Dexamethasone
|
|---|---|---|
|
Progression Free Survival
|
18.3 months
Interval 15.5 to 20.6
|
13.6 months
Interval 9.9 to 16.1
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
Adverse Events
Thal + Dex + Velcade
Serious events: 58 serious events
Other events: 0 other events
Deaths: 0 deaths
Thal + Dex
Serious events: 45 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Thal + Dex + Velcade
n=135 participants at risk
Velcade (Bortezomib)
Thalidomide
Dexamethasone
Allocated to treatment (n=135) Received allocated treatment (n=135)
|
Thal + Dex
n=134 participants at risk
Standard treatment
Thalidomide
Dexamethasone
Allocated to treatment (n=134) Received allocated treatment (n=134)
|
|---|---|---|
|
Nervous system disorders
Neuropathy
|
2.2%
3/135 • Number of events 3
|
0.00%
0/134
|
|
Renal and urinary disorders
Renal Failure
|
2.2%
3/135 • Number of events 3
|
0.75%
1/134 • Number of events 1
|
|
Hepatobiliary disorders
Pancreatitis
|
0.74%
1/135 • Number of events 1
|
0.00%
0/134
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.74%
1/135 • Number of events 1
|
0.00%
0/134
|
|
Reproductive system and breast disorders
Lung Carcinoma
|
0.00%
0/135
|
1.5%
2/134 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma
|
0.74%
1/135 • Number of events 1
|
1.5%
2/134 • Number of events 2
|
|
Vascular disorders
Vascular Pain
|
0.00%
0/135
|
0.75%
1/134 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
11.1%
15/135 • Number of events 15
|
5.2%
7/134 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Asthenia
|
0.74%
1/135 • Number of events 1
|
0.75%
1/134 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.74%
1/135 • Number of events 2
|
0.00%
0/134
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/135
|
1.5%
2/134 • Number of events 2
|
|
Infections and infestations
Infection
|
11.9%
16/135 • Number of events 21
|
3.0%
4/134 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
4.4%
6/135 • Number of events 6
|
1.5%
2/134 • Number of events 3
|
|
General disorders
Various other SAEs
|
23.0%
31/135 • Number of events 46
|
22.4%
30/134 • Number of events 39
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place