Active — Not RecruitingPhase 3

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

United States106 participantsStarted 2023-10-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of participants who achieve red blood cell transfusion independence (RBC-TI) for 8 weeks with a simultaneous mean hemoglobin (Hb) increase of ≥ 1 g/dL from Week 1 to Week 24

Timeframe: Up to week 24

Trial details

NCT IDNCT06045689

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-01

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