NCT07752121Not yet recruiting
First-Line Luspatercept in Transfusion-Dependent Lower-Risk Myelodysplastic Neoplasms
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
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 190 (estimated)
- First submitted
- 13 Jul 2026
- Start date
- 24 Aug 2026
- Primary completion date
- 31 Aug 2030
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Myelodysplastic syndromes
- NCT number
- NCT07752121
What you commit to
- Study type: Observational
- Planned participants: 190
- From 24 Aug 2026 to the primary completion date, 31 Aug 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- Contraindication according to the Reblozyl® (luspatercept) Summary of Product Characteristics (SmPC).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsmedizin der Johannes Gutenberg-Univ. III. Med. Klinik Hämatologie/Onkologie Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.