drugset / Trial / NCT01971658

Efficacy Study Comparing Velcade Dexamethasone Thalidomide Versus Velcade Cyclophosphamide Dexamethasone as Induction Treatment in the Initial Management of Multiple Myeloma (IFM2013-04)

NCT01971658

Phase 3 Completed 358 enrolled Nantes University Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2013-10
Primary completion
2015-08
Completion
2015-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclophosphamide Other / unclassified 500 mg/m2 Oral
Comparator Thalidomide Other / unclassified 100 mg Oral
Comparator Bortezomib Small molecule 1.3 mg/m2 Subcutaneous
Comparator Dexamethasone Small molecule 40 mg Oral

Indications