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.
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
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).
Adult participants with red blood cell transfusion-dependent lower-risk myelodysplastic neoplasms receiving first-line luspatercept in routine clinical practice in Germany.
Cohort
Prospective
Luspatercept
DrugAs per product label
Percentage of participants achieving red blood cell transfusion independence (RBC-TI) for at least 8 consecutive weeks
Percentage of participants achieving red blood cell transfusion independence for at least 12 consecutive weeks
Percentage of participants achieving red blood cell transfusion independence for at least 16 consecutive weeks
Mean change from baseline in hemoglobin concentration
Hemoglobin concentration (g/dL) measured during routine clinical practice.
Percentage of participants with hemoglobin increase of at least 1.5 g/dl from baseline
Hemoglobin concentration (g/dL) measured during routine clinical practice.
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