drugset / Trial / NCT00657488
Thalidomide 100 mg/Day Versus Thalidomide 400 mg/Day in Relapse Refractory Multiple Myeloma
RandomizedParallel-groupOpen-labelTreatment
Summary
The objective of this study is to show that thalidomide at a dose of 100 mg/d (with remedial treatment with dexamethasone if a progression occurs) is equivalent in terms of efficacy with thalidomide at 400 mg/d (with remedial treatment with dexamethasone if a progression occurs) in the treatment of refractory or relapsed multiple myeloma after at least two courses of treatment. The use of thalidomide at 100 mg/d should reduce the side effects and improve the safety of the treatment.
Timeline
- Start
- 2001-12-01
- Primary completion
- 2005-10-01
- Completion
- 2006-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Thalidomide | Other / unclassified | 100 mg | — |
| Subject | Thalidomide | Other / unclassified | 400 mg | — |