Clinical trial Recruiting at 1 site Observational Ages 19 and up

Assessing the safety of luspatercept in Korean patients with myelodysplastic syndrome or beta thalassemia

Official title: Reblozyl® (Luspatercept) Post-Marketing Surveillance in Korean Patients With Myelodysplastic Syndrome or Beta Thalassemia

Run by Bristol-Myers Squibb · NCT06073860 · Data updated 2026-11-12

This study is testing how safe the drug luspatercept is for adult Korean patients with myelodysplastic syndrome or beta thalassemia while they are being treated.

More Myelodysplastic Syndrome trials

Quick facts

Study typeObservational
Ages19 Years and up
SexAll
Enrollment104 (estimated)
SponsorBristol-Myers Squibb
Industry-sponsored
Locations2 sites (Seoul and 1 other locations)
StatusRecruiting
StartedMarch 25, 2024
Main results expectedDecember 21, 2027
Study endsDecember 21, 2027
Registry record updatedNovember 6, 2024
Trial IDNCT06073860 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adult patients aged 19 years or older who are beginning treatment with luspatercept as per the approved guidelines in Korea.

Probably not a fit

Patients who are receiving luspatercept for unapproved therapeutic indications or have contraindications as per Korean regulations may not benefit from this study.

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 aims to evaluate the real-world safety of luspatercept in adult Korean patients diagnosed with myelodysplastic syndrome (MDS) or beta thalassemia. Participants will be enrolled after starting treatment with luspatercept, and their safety outcomes will be monitored throughout the study. The study focuses on collecting data on adverse events and overall patient health in a real-world setting, providing insights into the drug's safety profile in this specific population.

Why it matters

Potential benefit: If successful, this study could provide valuable safety data that may enhance treatment protocols for patients with MDS or beta thalassemia.

How similar studies have gone: While this study focuses on a specific population and treatment, similar observational studies have previously shown success in assessing drug safety in real-world settings.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Adult participants 19 years of age or older
* Participants who will be treated with luspatercept according to the approved label in the Republic of Korea
* Participants who sign the informed consent form

Exclusion Criteria:

* Participants who are prescribed luspatercept for therapeutic indications not approved in the Republic of Korea
* Participants for whom luspatercept is contraindicated as clarified in the Korean prescribing information approved by the Ministry of Food and Drug Safety

Where it's running

  • Novotech Laboratory Korea Co., Ltd.
    Seoul, South Korea
    Recruiting
  • Local Institution - 0001
    Seoul, South Korea
    Terminated

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.