• Completed

NCT00507442: Phase 1/2 Study of VELCADE® in Combination With Other Drugs to Treat NDMM EVOLUTION

Updated: Jun 15


EVOLUTION


Phase 1/2 Study of VELCADE® in Combination With Other Drugs to Treat Previously Untreated Multiple Myeloma Patients (EVOLUTION)

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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.


Sponsor

Millennium Pharmaceuticals, Inc.


Collaborator

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)

 

VDR

VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide)


VDCR

VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide)


VDC

VELCADE (bortezomib), dexamethasone, cyclophosphamide


VDC-mod

Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide

 

Blood;2012

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

 

Locations

United States, Colorado

Rocky Mountain Cancer Center

United States, Minnesota

Mayo Clinic

Rochester, Minnesota



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