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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06073860
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Anticipated Duration (Months): 70.9
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndrome; Beta Thalassemia	Drug: Luspatercept

Study Design

• Study Type: Observational
• Anticipated Enrollment: 104 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Reblozyl® (Luspatercept) Post-Marketing Surveillance in Korean Patients With Myelodysplastic Syndrome or Beta Thalassemia
• Anticipated Study Start Date: Oct 31, 2023
• Anticipated Primary Completion Date: Dec 20, 2028
• Anticipated Study Completion Date: Sep 27, 2029

Arms and Interventions

Arm	Intervention/Treatment
Participants with myelodysplastic syndrome or beta thalassemia who will begin luspatercept treatment	Drug: Luspatercept; According to the approved label

Outcome Measures

Primary Outcome Measures

1. Number of participants with adverse events (AEs) [Up to 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bristol-Myers Squibb YH	Seoul		Korea, Republic of	06178

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT06073860
• Other Study ID Numbers: CA056-005
• First Posted: Oct 10, 2023
• Last Update Posted: Oct 10, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Preleukemia; Myelodysplastic Syndromes; Thalassemia; beta-Thalassemia; Syndrome; Luspatercept

Study Results

No Results Posted as of Oct 10, 2023