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

Bristol-Myers Squibb (BMS)

Status: Enrolling

Conditions: Myelodysplastic Syndrome; Beta Thalassemia

Treatments: Drug: Luspatercept

Study type: Observational

Funder types: Industry

Identifiers

NCT06073860

CA056-005

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

104 participants in 1 patient group

Participants with myelodysplastic syndrome or beta thalassemia who will begin luspatercept treatment

Treatment:

Drug: Luspatercept