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Trial ID CA056-1060  |   NCT06045689

A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants

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Sorry, this study is no longer accepting new participants, but is still ongoing.
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Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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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Key Eligibility Criteria

Inclusion Criteria

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:
  • 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.
    1. Participant has an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2.
      1. Participant must have red blood cell transfusions according to study criteria.

        Exclusion Criteria

        Exclusion Criteria Icon
        :
        • Participant has known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding.
          1. Participant has had a prior allogeneic or autologous stem cell transplant.
            1. Participant has known history or diagnosis of AML.
              1. Participant has uncontrolled hypertension. Other protocol-defined inclusion/exclusion criteria apply
                Additional Information *

                Treatment Options

                Study Arms

                ASSIGNED INTERVENTION

                Study Arms

                Experimental: Cohort 1: erythropoiesis-stimulating agents (ESA) naïve

                ASSIGNED INTERVENTION
                • Drug: Luspatercept

                Study Arms

                Experimental: Cohort 2: ESA relapsed or refractory

                ASSIGNED INTERVENTION
                • Drug: Luspatercept

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