NCT00507442: Phase 1/2 Study of VELCADE® in Combination With Other Drugs to Treat NDMM EVOLUTION
Updated: Jun 15
Phase 1/2 Study of VELCADE® in Combination With Other Drugs to Treat Previously Untreated Multiple Myeloma Patients (EVOLUTION)
The purpose of this Phase 1/2 study is to evaluate the efficacy and safety of treatment with VELCADE, dexamethasone, and Revlimid® (VDR) as well as VELCADE, dexamethasone, cyclophosphamide, and Revlimid (VDCR) in patients with multiple myeloma who have received no prior treatment. This study will evaluate whether the addition of Revlimid to VELCADE and Dexamethasone will increase the complete response (CR)/ very good partial response (VGPR) rate.
Millennium Pharmaceuticals, Inc.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00833560
Official Title: Phase 1/2 Study of VELCADE® (Bortezomib), Dexamethasone, and Revlimid® (Lenalidomide) Versus VELCADE, Dexamethasone, Cyclophosphamide, and Revlimid Versus VELCADE, Dexamethasone and Cyclophosphamide in Subjects With Previously Untreated Multiple Myeloma
First Posted : July 26, 2007
Click here to see details on ClinicalTrials.gov
Drug: VELCADE (bortezomib)
Drug: Revlimid (lenalidomide)
VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide)
VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide)
VELCADE (bortezomib), dexamethasone, cyclophosphamide
Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide
Randomized, multicenter, phase 2 study (EVOLUTION) of combinations of bortezomib, dexamethasone, cyclophosphamide, and lenalidomide in previously untreated multiple myeloma
All regimens were highly active and well tolerated in previously untreated MM, and, based on this trial, VDR and VCD-mod are preferred for clinical practice and further comparative testing. No substantial advantage was noted with VDCR over the 3-drug combinations. This trial is registered at www.clinicaltrials.gov
Bortezomib, dexamethasone, cyclophosphamide and lenalidomide combination for newly diagnosed multiple myeloma: phase 1 results from the multicenter EVOLUTION study
United States, Colorado
Rocky Mountain Cancer Center
United States, Minnesota