• Completed

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


Bortezomib : National Cancer Institute

Bortezomib : MedlinePlus Drug Information

Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information

Cyclophosphamide : National Cancer Institute

Cyclophosphamide : MedlinePlus Drug Information

Cyclophosphamide IV : MedlinePlus Drug Information


Drug: VELCADE (bortezomib)

Drug: dexamethasone

Drug: cyclophosphamide

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

Click here for details


Leukemia; 2010

Bortezomib, dexamethasone, cyclophosphamide and lenalidomide combination for newly diagnosed multiple myeloma: phase 1 results from the multicenter EVOLUTION study

Click here for details



United States, Colorado

Rocky Mountain Cancer Center

United States, Minnesota

Mayo Clinic

Rochester, Minnesota

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