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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jul 2020

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At a glance

  • Drugs Dexamethasone (Primary) ; Lenalidomide (Primary) ; Melphalan; Prednisone; Thalidomide
  • Indications Multiple myeloma
  • Focus Registrational; Therapeutic Use
  • Acronyms FIRST
  • Sponsors Celgene Corporation

    • Most Recent Events

    • 21 Jun 2020 Results of sub-analysis assessing characterization of relapse and second-line therapy in lenalidomide-refractory patients, presented at the 25th Congress of the European Haematology Association.
    • 06 Nov 2019 Results (n= 389) (data cutoff- January 2016) of Characterization of Relapse and Second-Line Therapy in Lenalidomide-Refractory, Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma: A Subanalysis of the Phase 3 First Trial has released at the 61st Annual Meeting and Exposition of the American Society of Hematology
    • 13 Jun 2019 This trial has been completed in United Kingdom, according to European Clinical Trials Database.
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