Assessing the safety of luspatercept in Korean patients with myelodysplastic syndrome or beta thalassemia
Reblozyl® (Luspatercept) Post-Marketing Surveillance in Korean Patients With Myelodysplastic Syndrome or Beta Thalassemia
This study is testing how safe the drug luspatercept is for adult Korean patients with myelodysplastic syndrome or beta thalassemia while they are being treated.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 104 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT06073860 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the real-world safety of luspatercept in adult Korean patients diagnosed with myelodysplastic syndrome (MDS) or beta thalassemia. Participants will be enrolled after starting treatment with luspatercept, and their safety outcomes will be monitored throughout the study. The study focuses on collecting data on adverse events and overall patient health in a real-world setting, providing insights into the drug's safety profile in this specific population.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients aged 19 years or older who are beginning treatment with luspatercept as per the approved guidelines in Korea.
Not a fit: Patients who are receiving luspatercept for unapproved therapeutic indications or have contraindications as per Korean regulations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable safety data that may enhance treatment protocols for patients with MDS or beta thalassemia.
How similar studies have performed: While this study focuses on a specific population and treatment, similar observational studies have previously shown success in assessing drug safety in real-world settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul and 1 other locations
- Local Institution - 0001 — Seoul, South Korea (Terminated)
- Novotech Laboratory Korea Co., Ltd. — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.