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

NCT06073860 | Recruiting FDA Drug

• 1 other identifier: CA056-005
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Myelodysplastic Syndrome; Beta Thalassemia

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events (AEs)

  Up to 6 months

Study Arms (1)

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

Drug: Luspatercept

Interventions

Luspatercept DRUG

According to the approved label

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Local Institution - 0001

Seoul, 06234, South Korea

TERMINATED

Novotech Laboratory Korea Co., Ltd.

Seoul, 06234, South Korea

RECRUITING

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Myelodysplastic Syndromes; beta-Thalassemia

Interventions

luspatercept

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: March 25, 2024
• Primary Completion (Estimated): December 21, 2027
• Study Completion (Estimated): December 21, 2027
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)