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

Bristol-Myers Squibb104 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

104

Conditions

Myelodysplastic Syndrome Beta Thalassemia

Interventions

LuspaterceptDRUG

According to the approved label

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (2)

Local Institution - 0001

Seoul, South Korea

TERMINATED

Novotech Laboratory Korea Co., Ltd.

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Number of participants with adverse events (AEs)

Time frame: Up to 6 months

Central Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Data from ClinicalTrials.gov

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