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)

Description

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.

Trial Eligibility

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

Study Info

Interventions

Locations Recruiting

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