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

• Status: Recruiting
• Trial end date: 2027-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Luspatercept

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