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Phase III

A Phase 3b, Open-label Study Evaluating the Efficacy and Safety of Luspatercept (BMS-986346/ACE-536) Initiated at Maximum Approved Dose in LR-MDS With IPSS-R Very Low-, Low-, or Intermediate-risk Who Require RBC Transfusions (MAXILUS)

  • Study HIC#:2000036207
  • Last Updated:04/17/2024

The purpose of this study is to evaluate the efficacy and safety of Luspatercept when administered at the maximum approved dose in low-risk Myelodysplastic Syndrome participants who require red blood cell transfusions.

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    Eligibility Criteria

    Inclusion Criteria:

    • Participant had documented diagnosis of MDS according to World Health Organization (WHO) classification that met Revised International Prognostic Scoring System (IPSS-R) classification of very low-, low-, or intermediate-risk disease.
    • Participant has an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2.
    • Participant must have red blood cell transfusions according to study criteria.

    Exclusion Criteria:

    • Participant has known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding.
    • Participant has had a prior allogeneic or autologous stem cell transplant.
    • Participant has known history or diagnosis of AML.
    • Participant has uncontrolled hypertension.

    Other protocol-defined inclusion/exclusion criteria apply

    Principal Investigator


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