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Study in Myeloma Patients Newly Diagnosed Treated as an Induction With Velcade-Dex or Velcade (Bortezomib) Thalidomide Dexamethasone (VTD)

Multiple Myeloma Clinical Trial

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

Clinical Trial Summary

Primary objective:

- 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.

Secondary objectives:

- 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).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00910897
Study type Interventional
Source Intergroupe Francophone du Myelome
Contact
Status Active, not recruiting
Phase Phase 3
Start date March 2008
View Details
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