IFM2013-04
- Conditions
- Young untreated patients with Multiple myelomaTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2013-003174-27-FR
- Lead Sponsor
- CHU de Nantes
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
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 330
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): The primary endpoint is the VGPR rate achieved with four courses of VTD with that achieved with four courses of VCD;Timepoint(s) of evaluation of this end point: 17 months;Main Objective: compare the VGPR rate achieved with four courses of VTD with that achieved with four courses of VCD<br>;Secondary Objective: - To compare the following parameters after induction treatment with four courses of VTD or four courses of VCD:<br>•the CR rate<br>•the PR rate<br>- To evaluate the Safety of induction therapy<br>- To evaluate the quality of stem cell collection<br>- To evaluate Overall and Progression-Free Survival.<br>
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 17 months;Secondary end point(s): The secondary endpoints include :<br>•the CR rate achieved with four courses of VTD and with that achieved with four courses of VCD<br>•the PR rate achieved with four courses of VTD and with that achieved with four courses of VCD<br><br>- Safety of induction therapy<br>- Quality of stem cell collection<br>- Duration of response measured as the time from the date of randomisation to the date of first documented progression-free and overall survival<br>