• Completed

NCT00689936: Phase 3 - Lenalidomide+low dose dex vs Melphalan, Prednisone, Thalidomide in NDMM FIRST

Updated: Jun 22

FIRST study

IFM 07-01

CC-5013-MM020

IFM 07-01 CC-5013-MM020


Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients with Previously Untreated Multiple Myeloma (FIRST)


The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide.


CC-5013-MM020/IFM 07-01 is a Phase III, multicenter, randomized, open-label, 3-arm study that will compare the efficacy and safety of two Lenalidomide plus low-dose dexamethasone regimens given for two different durations of time (i.e., until progressive disease [PD] or for up to a maximum of 18 four-week cycles) to that of MPT given for a maximum of 12 six-week cycles.


Sponsor

Celgene


Multiple Locations

International Study

 

ClinicalTrials.gov Identifier: NCT00689936

Official Title: A Phase III, Randomized, Open-label, 3-arm Study to Determine the Efficacy and Safety of Lenalidomide (REVLIMID) Plus Low-dose Dexamethasone When Given Until Progressive Disease or for 18 Four-week Cycles Versus the Combination of Melphalan, Prednisone, and Thalidomide Given for 12 Six-week Cycles in Patients with Previously Untreated Multiple Myeloma Who Are Either 65 Years of Age or Older or Not Candidates for Stem Cell Transplantation.

First Posted : June 4, 2008

https://clinicaltrials.gov/ct2/show/NCT00689936


EudraCT Number 2007-004823-39 - Clinical trial results - EU Clinical Trials Register

 

Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information

 

Drug: Lenalidomide and low-dose dexamethasone

Drug: Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles

Drug: Melphalan, Prednisone and Thalidomide

 

Publications:


Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma.

N Engl J Med. 2014 Sep 4

https://pubmed.ncbi.nlm.nih.gov/25184863/


Benefit of continuous treatment for responders with newly diagnosed multiple myeloma in the randomized FIRST trial.

Leukemia. 2017 Nov

https://pubmed.ncbi.nlm.nih.gov/28373701/


Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial.

Br J Haematol. 2017 March

https://pubmed.ncbi.nlm.nih.gov/28106903/


Impact of renal impairment on outcomes with lenalidomide and dexamethasone treatment in the FIRST trial, a randomized, open-label phase 3 trial in transplant-ineligible patients with multiple myeloma.

Haematologica. 2016 March

https://pubmed.ncbi.nlm.nih.gov/26659916/


Updated Outcomes and Impact of Age with Lenalidomide and Low-Dose Dexamethasone or Melphalan, Prednisone, and Thalidomide in the Randomized, Phase III FIRST Trial.

J Clin Oncol. 2016 Oct

https://pubmed.ncbi.nlm.nih.gov/27325857/


Final analysis of survival outcomes in the phase 3 FIRST trial of up-front treatment for multiple myeloma.

Blood. 2018 Jan 18

https://pubmed.ncbi.nlm.nih.gov/29150421/

 

Drug: Lenalidomide (Revlimid) and low-dose dexamethasone

Drug: Lenalidomide (Revlimid) plus low-dose dexamethasone given for 18 four-week cycles

Drug: Melphalan, Prednisone and Thalidomide

 

- Alabama: University of Alabama at Birmingham

- California: University of California San Francisco

- Illinois: Rush University Medical Center Chicago

- Minnesota: Mayo Clinic Rochester Minnesota

- Ohio: Cleveland Clinic Ohio

- Pennsylvania: University of Pennsylvania Philadelphia

- Washington: Fred Hutchinson Cancer Center Seattle

 

Locations

United States, Alabama

United States, California

United States, Florida

United States, Illinois

United States, Kansas

United States, Maine

United States, Maryland

United States, Minnesota

United States, Montana

United States, New York

United States, North Dakota

United States, Ohio

United States, Oregon

United States, Pennsylvania

United States, Tennessee

United States, Texas

United States, Washington

Canada, Alberta

Canada, British Columbia

Canada, New Brunswick

Canada, Nova Scotia

Canada, Ontario

Canada, Quebec

Canada

Australia, South Australia

Australia, Victoria

Australia

New Zealand

Europe

United Kingdom

Austria

Belgium

France

Germany

Greece

Ireland

Italy

Portugal

Spain

Sweden

Switzerland

Asia

China

Korea, Republic of

Taiwan








Posts Archive