A randomized controlled study of Velcade (Bortezomib) plus Thalidomide plus Dexamethasone compared to Thalidomide plus Dexamethasone for the treatment of myeloma patients progressing or relapsing after autologous transplantation - MMVAR
- Conditions
- multiple myeloma patients in progression or relapse after autologous transplantation
- Registration Number
- EUCTR2005-001628-35-BE
- Lead Sponsor
- EBMT - CLWP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 452
-histologically confirmed diagnosis of multiple myeloma with evaluable disease parameters
-relapsing or having a progressive disease at least one year after an autologous transplantation
-karnofsky index more than 50%
-post-menopausal or surgically sterilized or willing to use an acceptable method of birth control
-written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
-patient with non-secretory MM
-Creat clearance lower than 30 ml/min, platelets lower then 40000, ANC lower than 1000
-peripheral neuropathy of grade 2 or more within 14 days before enrollment
-HIV, hepatitis A,B,C positive
-female subject pregnant or breast-feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: test the hypothesis that treatment with Velcade plus Thalidomide plus Dexamethasone in combination, will result in a longer time to progression (TTP) than Thalidomide plus Dexamethasone in subjects with relapsed or progressive myeloma after autologous transplantation;Secondary Objective: to compare the treatment groups for :<br>- response rate (complete + partial + minimal) using standard criteria<br>-overall survival<br>- side effects;Primary end point(s): Time to Progression
- Secondary Outcome Measures
Name Time Method