drugset / Trial / NCT00256776

MMVAR - Velcade: Study of Velcade for the Treatment of Myeloma Patients After Autologous Transplantation

NCT00256776

RandomizedParallel-groupOpen-labelTreatment

Summary

This is an international study in adult patients diagnosed with multiple myeloma who have already received at least one autologous stem cell transplantation and who have responded but later progressed, or relapsed, at least one year after transplantation. Eligible patients will be randomly assigned to one of two treatments: either Velcade plus Thalidomide plus Dexamethasone or Thalidomide plus Dexamethasone. Thalidomide and Velcade are two new agents that have recently become available for the treatment of multiple myeloma, especially in relapsed patients. This study therefore aims to test the hypothesis that the combination treatment with Velcade plus Thalidomide plus Dexamethasone will result in a longer time to progression (measure of time after the disease is treated until it starts to get worse) than Thalidomide plus Dexamethasone alone.

Timeline

Start
2005-07
Primary completion
2013-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.3 mg/m2 Intravenous
Subject Dexamethasone Small molecule 40 mg Oral
Subject Thalidomide Other / unclassified 200 mg Oral

Indications