NCT00689936: Phase 3 - Lenalidomide+low dose dex vs Melphalan, Prednisone, Thalidomide in NDMM FIRST
Updated: Jun 22, 2022
FIRST study
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
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
Benefit of continuous treatment for responders with newly diagnosed multiple myeloma in the randomized FIRST trial.
Leukemia. 2017 Nov
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
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
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
Final analysis of survival outcomes in the phase 3 FIRST trial of up-front treatment for multiple myeloma.
Blood. 2018 Jan 18
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