First-Line Luspatercept in Transfusion-Dependent Lower-Risk Myelodysplastic Neoplasms

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Conditions studied: Myelodysplastic Neoplasms

In brief

This study will observe adults with lower-risk myelodysplastic neoplasms (MDS) who have anemia requiring regular red blood cell transfusions and who are prescribed first-line luspatercept as part of routine medical care. The study will follow participants for up to 2 years to understand how often treatment leads to periods without transfusions, changes in hemoglobin levels, health-related quality of life, and safety outcomes. Information on treatment use and outcomes in routine clinical practice in Germany will also be collected.

Key facts

Study ID

NCT07752121

Run by

Bristol-Myers Squibb

People needed

190

Starts

2026-08-24

Expected to finish

2030-08-31

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females ≥18 years of age at enrollment.
• Documented diagnosis of myelodysplastic neoplasms according to World Health Organisation (WHO) 2022 or WHO 2016 classification meeting International Prognostic Scoring System-Revised (IPSS-R) criteria for very low-, low-, or intermediate-risk disease.
• Documented red blood cell transfusion dependence of ≥2 units of red blood cells within the 8 weeks preceding Day 1 treatment initiation.
• First-line treatment based on the approved luspatercept label and decision for treatment with luspatercept as assessed by the treating physician prior to study participation
• Provision of written informed consent.

You may not qualify if…

• Contraindication according to the Reblozyl® (luspatercept) Summary of Product Characteristics (SmPC).
• Parallel participation in an interventional clinical trial (except follow-up phase as specified in protocol).
• Patients who have completed their participation in an interventional clinical trial or who are not receiving any study drug anymore and who are only in the follow-up phase can be enrolled. For blinded studies, the study drug administered needs to be known at the time of enrolment.
• Concurrent malignancy requiring treatment.

Where it is running

• Universitätsmedizin der Johannes Gutenberg-Univ. III. Med. Klinik Hämatologie/Onkologie — Mainz, Germany

Full record on ClinicalTrials.gov

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