Study in Myeloma Patients Newly Diagnosed Treated as an Induction With Velcade-Dex or Velcade (Bortezomib) Thalidomide Dexamethasone (VTD)
|ClinicalTrials.gov Identifier: NCT00910897|
Recruitment Status : Unknown
Verified May 2009 by Intergroupe Francophone du Myelome.
Recruitment status was: Active, not recruiting
First Posted : June 1, 2009
Last Update Posted : June 1, 2009
- Compare the complete remission (CR) rates (i.e., the true CR, with negative immunofixation) achieved with either four courses of VD or four courses of VTD.
Compare the following parameters following 4 cycles of VD or VTD induction treatment:
- CR rate+ very good partial remission (VGPR) rate
- Overall remission rate (CR + VGPR + partial remission (PR) rate)
- K/l light chain ratio in patients in CR.
- Safety (quality of the sampled stem cells, extrahaematological and haematological toxicity: specially neurological toxicity, length of hospitalization).
- Compare the CR rate and the CR + VGPR rates after post-induction autologous stem cell transplantation (ASCT).
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Velcade-Dexamethasone Drug: Velcade-Thalidomide-Dexamethasone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||205 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3 Study of Velcade (Bortezomib) Dexamethasone (VD) Versus Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) as an Induction Treatment Prior to Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma|
|Study Start Date :||March 2008|
|Estimated Primary Completion Date :||August 2009|
|Active Comparator: Velcade-Dexamethasone||Drug: Velcade-Dexamethasone|
|Active Comparator: Velcade-Thalidomide-Dexamethasone||Drug: Velcade-Thalidomide-Dexamethasone|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00910897
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