First-line luspatercept use in adults with lower-risk transfusion-dependent MDS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study tracks adults with lower-risk myelodysplastic neoplasms who are starting first-line luspatercept in routine clinical practice. Participants will be observed for up to 24 months to collect data on transfusion independence, hemoglobin changes, health-related quality of life, and safety. The study will also gather real-world information on how luspatercept is used and the associated outcomes in Germany. Data collection relies on standard medical care and chart review, without a randomized comparison group. The primary aim is to describe patterns of use and clinical outcomes in a real-world setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• Universitätsmedizin Johannes Gutenberg Universität Mainz
  Mainz, Germany Recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.