A Post-Marketing Surveillance Study to Assess Safety of Luspatercept in Korean Patients With Myelodysplastic Syndrome or β-thalassemia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorBristol-Myers Squibb

About this trial

The purpose of this observational study is to assess the real-world safety of luspatercept in Korean participants with myelodysplastic syndrome (MDS) or beta thalassemia. Investigators will enroll participants who will begin treatment with at least 1 dose of luspatercept.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Adults with transfusion-dependent anemia associated with very low, low, and intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS) or MDS/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) who had an unsatisfactory response to, or are ineligible for erythropoietin-based therapy, and adults with transfusion-dependent anemia associated with beta thalassemia, who will begin therapy with luspatercept.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Luspatercept

    Drug

    According to the approved label

Treatment groups

104 Participants
are divided into 1 treatment group
Group A: Participants with myelodysplastic syndrome or beta thalassemia who will begin luspatercept treatment1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with adverse events (AEs)

Time frame
Up to 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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