Efficacy Study Comparing Velcade Dexamethasone Thalidomide Versus Velcade Cyclophosphamide Dexamethasone as Induction Treatment in the Initial Management of Multiple Myeloma (IFM2013-04) (IFM2013-04)
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|ClinicalTrials.gov Identifier: NCT01971658|
Recruitment Status : Completed
First Posted : October 29, 2013
Last Update Posted : October 7, 2015
This is a phase III, multicenter, prospective with a clinical benefit, open-label and randomized study to compare two different treatments : Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) versus Velcade (Bortezomib) Cyclophosphamide Dexamethasone (VCD) as an Induction Treatment prior to Autologous Stem Cell Transplantation in patients with Newly Diagnosed Multiple Myeloma.
Eligible patients will be randomized into 2 treatment arms. Each patient will receive 4 consecutive 21 day cycles of an induction treatment with either VTD or VCD.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Thalidomide® Drug: Cyclophosphamide Drug: Velcade® Drug: Dexaméthasone||Phase 3|
The patient population will consist of adult men and women who have a confirmed diagnosis of Multiple Myeloma and who meet eligibility criteria. They will be recruited from among the patients consulting in an investigating centre's haematology service for newly diagnosed, symptomatic, untreated multiple myeloma.
in each treatment arm there will be :
- Induction therapy : 4 cycles of VTD (21 days)or VCD
- Systematic stem cell harvest after cycle 3
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||358 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A PHASE III STUDY OF VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD) VERSUS VELCADE (BORTEZOMIB) CYCLOPHOSPHAMIDE DEXAMETHASONE (VCD) AS AN INDUCTION TREATMENT PRIOR TO AUTOLOGOUS STEM CELL TRANSPLANTATION IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA."|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Active Comparator: VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD)
Active Comparator: VELCADE (BORTEZOMIB) CYCLOPHOSPHAMIDE DEXAMETHASONE (VCD)
For arm B:
- Response assessment according to the criteria IMWG [ Time Frame: 15-17 month ]compare the Response assessment in both arms: the Very good partial remission rate (according to the criteria IMWG) achieved with four courses of VTD with that achieved with four courses of VCD
- Response assessment according to the criteria IMWG [ Time Frame: 15 - 17 month ]compare the Response assessment in both arms: the following parameters after induction treatment with four courses of VTD or four courses of VCD the Complete remission rate (according to the criteria IMWG)
- Number of Adverse Events [ Time Frame: 15-17 month ]To evaluate the Safety of induction therapy
- Number of collected stem cell [ Time Frame: 17 month ]
- Number of death [ Time Frame: 17 month ]To evaluate Overall and Progression-Free Survival
- Response assessment according to the criteria IMWG [ Time Frame: 15-17 month ]compare the Response assessment in both arms: Compare the following parameters after induction treatment with four courses of VTD or four courses of VCD the Partial remission rate (according to the criteria IMWG)
- Number of relapse according to the criteria IMWG [ Time Frame: 17 month ]Progression-Free Survival
- Comparison of three techniques for the quantification of urinary monoclonal components in patients with Newly Diagnosed Multiple Myeloma. [ Time Frame: 17 month ]
The detection and the estimation of the urinary monoclonal components is an inescapable element of the diagnosis and the evaluation of the therapeutic efficacy in the myeloma.
Urinary protein, electrophoresisin agarose gel is the quantitative method of choice. In these labs, the quantification of the urinary monoclonal peak is not performed. In the absence of quantitative data on urinary monoclonal components, the patient is considered as non-assessable. Recently, the company Sebia has developed the quantification on two other materials used specifically for the characterization of monoclonal component and / or proteinuria (HYDRAGEL BENCE JONES and HYDRAGEL URINE PROFILE).
The objective of this study is to compare the quantification of monoclonal components between the reference HR electrophoresis technique and the other two above-mentioned techniques.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971658
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|Principal Investigator:||Philippe MOREAU||Nantes University Hospital|