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A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) vs Epoetin Alfa for the Treatment of Anemia Due to Revised International Prognostic Scoring System (IPSS-R) Very Low, Low, or Intermediate-Risk Myelodysplastic Syndrome (MDS) in Erythropoiesis-Stimulating Agent (ESA)-Naive Participants Who Are Non-Transfusion Dependent (NTD): The ELEMENT-MDS Trial

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A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) vs Epoetin Alfa for the Treatment of Anemia Due to Revised International Prognostic Scoring System (IPSS-R) Very Low, Low, or Intermediate-Risk Myelodysplastic Syndrome (MDS) in Erythropoiesis-Stimulating Agent (ESA)-Naive Participants Who Are Non-Transfusion Dependent (NTD): The ELEMENT-MDS Trial

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Mar 2025

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At a glance

  • Drugs Luspatercept (Primary) ; Epoetin alfa
  • Indications Anaemia; Myelodysplastic syndromes
  • Focus Registrational; Therapeutic Use
  • Acronyms ELEMENT-MDS
  • Sponsors Bristol-Myers Squibb

    • Most Recent Events

    • 11 Sep 2023 Status changed from not yet recruiting to recruiting.
    • 20 Jul 2023 New trial record

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