Study in Myeloma Patients Newly Diagnosed Treated as an Induction With Velcade-Dex or Velcade (Bortezomib) Thalidomide Dexamethasone (VTD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
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): NCT00910897
Show 56 Study Locations