Observing first-line luspatercept in adults with lower-risk myelodysplastic neoplasms needing transfusions
Observes adults with lower-risk myelodysplastic neoplasms who receive luspatercept for anemia needing transfusions.
Plain-language title generated from the registry record
Registry title: First-Line Luspatercept in Transfusion-Dependent Lower-Risk Myelodysplastic Neoplasms
Key facts
- Where
- Mainz, GermanySee the site
Where in Germany
- Universitätsmedizin Johannes Gutenberg Universität MainzMainz, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT07752121
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
A Prospective, Multicenter, Non-Interventional Study Assessing First-line Luspatercept in Anemic Patients With Very Low, Low, or Intermediate Risk Myelodysplastic Neoplasms Requiring Red Blood Cell Transfusions
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.
Inclusion: 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: 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; Contraindication according to the Reblozyl® (luspatercept) Summary of Product Characteristics (SmPC).