drugset / Trial / NCT00908232

Treatment With Velcade (Bortezomib) Plus Dexamethasone (VD) or VD Plus Cyclophosphamide or VD Plus Lenalidomide in Patients With Multiple Myeloma Stabilized After 4 Cycles of VD

NCT00908232 ↗

Phase 2 Completed 163 enrolled Janssen-Cilag International NV
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to test the effectiveness and safety of adding cyclophosphamide or lenalidomide to the VD combination in the treatment of patients with multiple myeloma that have achieved a stable response after 4 initial cycles of treatment with VD. Multiple myeloma is the second most common cancer of the blood. Bortezomib disrupts the life cycle of the cell, affecting numerous biologic pathways, including those related to growth and survival of cancer cells.

Timeline

Start
2008-05
Primary completion
2011-08
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.3 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 500 mg Oral
Subject Dexamethasone Small molecule 20 mg Oral
Subject Lenalidomide Other / unclassified 10 mg Oral

Indications