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A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Placebo for the Treatment of Anemia Due to the IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in Subjects With Ring Sideroblasts Who Require Red Blood Cell Transfusions

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Trial Profile

A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Placebo for the Treatment of Anemia Due to the IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in Subjects With Ring Sideroblasts Who Require Red Blood Cell Transfusions

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jan 2024

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At a glance

  • Drugs Luspatercept (Primary)
  • Indications Anaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms MEDALIST
  • Sponsors Celgene Corporation

    • Most Recent Events

    • 12 Dec 2023 Results (As of January 2, 2023, n=11 ) presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 15 Jun 2023 Results of a multi-omics biomarker analysis identifying biological associations of luspatercept responseand non-response in MEDALIST patients, presented at the 28th Congress of the European Haematology Association
    • 01 Feb 2023 Results of a post-hoc sub-analysis assessing RBC transfusion units, visits based on patient's baseline transfusion burden level and clinical benefit of continuing luspatercept therapy over week 25 published in the Annals of Hematology
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