Actively Recruiting
Real-World Application of Luspatercept in Adults With Transfusion-Dependent Beta-Thalassemia in the Middle East (RELATE) Observational Study
Led by Bristol-Myers Squibb · Updated on 2026-06-02
200
Participants Needed
2
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating luspatercept treatment in adults with transfusion-dependent beta-thalassemia in the Middle East. This observational study aims to understand real-world use and outcomes of luspatercept, a drug given according to its product label, in people aged 18 and older who require regular blood transfusions due to beta-thalassemia. Participants in this study have started luspatercept treatment within the past 12 months and continue therapy as prescribed in routine care. The study collects data retrospectively and prospectively, observing changes in transfusion needs, pre-transfusion hemoglobin levels, and iron levels up to 144 weeks. Researchers also monitor transfusion-related visits, treatment duration, dose modifications, medical encounters, and reasons for treatment changes. During the study, participants' medical records are reviewed to assess transfusion burden, hemoglobin levels, iron chelation therapy, hospital visits, and other health outcomes. The study tracks long-term treatment patterns and safety events while collecting demographic and disease information. Participation involves ongoing treatment with luspatercept and regular data collection through week 144 to understand treatment effects and patient experience over time.
CONDITIONS
Brief Title
A Real-World Study to Evaluate Luspatercept in Adults With Transfusion-Dependent Beta-Thalassemia in the Middle East
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants of any race aged at least 18 years at time of luspatercept treatment initiation
- Documented diagnosis of transfusion-dependent beta-thalassemia
- Started luspatercept treatment no longer than 12 months before signing informed consent and are currently on therapy
- Decision to prescribe luspatercept is separate from decision to include participant in the study
- Signed informed consent for participation and data collection
You will not qualify if you...
- Contraindications to luspatercept according to the latest approved product information
- Currently receiving or planned to receive investigational drug/device/intervention or received such within 1 month or 5 half-lives prior to starting luspatercept
- Currently pregnant, breastfeeding, or planning pregnancy during study
- Have not provided signed informed consent for participation and data collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 144 weeks
Participants receive luspatercept treatment according to the product label and are monitored during therapy.
Visits as per routine clinical care during treatment
Duration - Up to 144 weeks
Participants are followed to assess outcomes including transfusion burden, hemoglobin levels, and other health measures up to 144 weeks.
Data collected during treatment visits and follow-up assessments
Trial Site Locations
Total: 2 locations
1
Sultan Qaboos University Hospital
Seeb, Muḩāfaz̧at Masqaţ, Oman, 123
Actively Recruiting
2
Prince Muhammad bin Nasser Hospital
Jizan, Saudi Arabia
Not Yet Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here