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

April 9, 2024 updated by: Bristol-Myers Squibb

Reblozyl® (Luspatercept) Post-Marketing Surveillance in Korean Patients With Myelodysplastic Syndrome or Beta Thalassemia

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 06178
        • Not yet recruiting
        • Bristol-Myers Squibb YH
        • Contact:
      • Seoul, Korea, Republic of, 06234
        • Recruiting
        • PPC Korea Co.,Ltd
        • Contact:
          • South Korea Generic Country, Site 0001
          • Phone Number: 0000000000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to 6 months
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2023

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

September 27, 2029

Study Registration Dates

First Submitted

October 3, 2023

First Submitted That Met QC Criteria

October 3, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA056-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myelodysplastic Syndrome

Clinical Trials on Luspatercept

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe