NCT00910897

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Intergroupe Francophone du Myelome · Network
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Velcade-Dexamethasone
DRUG	Velcade-Thalidomide-Dexamethasone

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-08-01
• First posted: 2009-06-01
• Last updated: 2009-06-01

Locations

56 sites across 2 countries: Belgium, France