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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Luspatercept

Treatment groups

190 Participants
are divided into 1 treatment group

Sponsors and collaborators