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: 27 Feb 2018

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

    • 27 Feb 2018 According to a BeiGene media release, based on the data from this trial, REVLIMID (lenalidomide) has been approved by the China Food and Drug Administration (CFDA) for the treatment of multiple myeloma (MM) in combination with dexamethasone in adult patients with previously untreated MM who are not eligible for transplant.
    • 12 Dec 2017 Results of validation of progression-free survival endpoint by using pooled data from two phase III studies (MM-020 and MM-015) presented at the 59th Annual Meeting and Exposition of the American Society of Hematology.
    • 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.
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