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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Nov 2017

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

    • 17 Nov 2017 Results assessing survival outcomes in patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM) treated with lenalidomide and low-dose dexamethasone until disease progression, were published in the Blood.
    • 24 Jan 2017 According to a Celgene media release, based on the safety and efficacy results of this study, Health Canada has expanded the indication for REVLIMID (lenalidomide capsules), in multiple myeloma.
    • 06 Dec 2016 Results of a final analysis of the overall survival presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
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