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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Luspatercept
DrugAccording to the approved label
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with adverse events (AEs)
Sponsors and contacts
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