drugset / Trial / NCT00657488

Thalidomide 100 mg/Day Versus Thalidomide 400 mg/Day in Relapse Refractory Multiple Myeloma

NCT00657488

Phase 2/3 Completed 400 enrolled Celgene Corporation
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

EvaluationDrugModalityDoseRoute
Subject Thalidomide Other / unclassified 100 mg
Subject Thalidomide Other / unclassified 400 mg

Indications