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A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) ESA in Native Subjects Who Require Red Blood Cell Transfusions

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Trial Profile

A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) ESA in Native Subjects Who Require Red Blood Cell Transfusions

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Jul 2024

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At a glance

  • Drugs Luspatercept (Primary) ; Epoetin alfa
  • Indications Anaemia; Myelodysplastic syndromes
  • Focus Registrational; Therapeutic Use
  • Acronyms COMMANDS
  • Sponsors Celgene Corporation
  • Most Recent Events

    • 04 Jun 2024 Results (as of As of March 31, 2023, )presented at the 60th Annual Meeting of the American Society of Clinical Oncology
    • 23 Feb 2024 According to a Bristol-Myers Squibb media release, company announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Reblozyl (luspatercept) as a treatment for adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS). The CHMP adopted a positive opinion based on results from this pivotal Phase 3 COMMANDS trial.
    • 12 Dec 2023 Results(As of Mar 31, 2023,n=182) full efficacy and safety analysis of this study , presented at the 65th American Society of Hematology Annual Meeting and Exposition
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