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Not Yet Recruiting NCT07752121

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

Conditions: Myelodysplastic Neoplasms

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 190
Sponsor: Bristol-Myers Squibb

Location: Universitätsmedizin der Johannes Gutenberg-Univ. III. Med. Klinik Hämatologie/Onkologie Mainz

Summary

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

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07752121). StuddyBuddy aggregates publicly available trial information.