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)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |