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Trial ID CA056-1060  |   NCT06045689

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

Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • 56
    Locations
  • BMS Recruiting Study icon
    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: - 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

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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