Luspatercept for adults with transfusion-dependent beta-thalassemia in the Middle East

REal-World Application of Luspatercept in Adults With Transfusion-Dependent Beta-Thalassemia in the Middle East (RELATE): A Non-interventional Retrospective and Prospective Observational Study

This project tests whether luspatercept can reduce blood transfusion needs in adults with transfusion-dependent beta-thalassemia in the Middle East.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bristol-Myers Squibb (Industry-sponsored)
• Locations: 2 sites (Seeb, Muḩāfaz̧at Masqaţ and 1 other locations)
• Trial ID: NCT07215975 on ClinicalTrials.gov

What this trial studies

This is a real-world, observational study collecting medical data from adults treated with luspatercept at participating hospitals in the Middle East. Eligible participants are adults (≥18 years) with documented transfusion-dependent beta-thalassemia who started luspatercept no more than 12 months before giving consent and continue on therapy. Treatment decisions were made independently of study enrollment and luspatercept is given per the product's local Summary of Product Characteristics. The study will analyze clinical outcomes and transfusion burden using routinely collected medical records from the participating sites.

Who should consider this trial

Good fit: Adults (18+) with documented transfusion-dependent beta-thalassemia who began and continue luspatercept therapy within the past 12 months and receive care at one of the participating sites are ideal candidates.

Not a fit: Patients with contraindications to luspatercept per the local product label, children, non–transfusion-dependent patients, those who stopped therapy, or those who started luspatercept more than 12 months before consent are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, luspatercept treatment could reduce the frequency of transfusions and improve anemia management, lowering iron overload and transfusion-related complications.

How similar studies have performed: Previous randomized trials (for example, the BELIEVE trial) have shown that luspatercept can reduce transfusion burden in transfusion-dependent beta-thalassemia, so this real-world study builds on established clinical evidence.

Eligibility criteria

Inclusion Criteria:

* Male or female participants of any race aged at least 18 years at time of initiation of luspatercept treatment
* Participants with documented diagnosis of transfusion-dependent β-thalassemia (TDT).
* Participants who have been initiated on treatment with luspatercept as per the product's Summary of Product Characteristics (SmPC) no longer than 12 months prior to informed consent signature, and for whom therapy is ongoing.
* Participants for whom the decision to prescribe luspatercept treatment is clearly separated from the physician's decision to include the participant in the current study.
* Participants who have provided signed informed consent for participating in the study and for collecting and analyzing medical data pertinent to the objectives of this study

Exclusion Criteria:

* Participants that meet any of the contraindications to the administration of luspatercept as outlined in the latest version of the locally approved SmPC.
* Participants who are currently receiving or are planned to receive treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to luspatercept therapy initiation.
* Participants who are currently pregnant, breastfeeding, or planning a pregnancy during the study observation period.
* Participants who have not provided signed informed consent for participating in the study and for collecting and analysing medical data pertinent to the objectives of this study.

Where this trial is running

Seeb, Muḩāfaz̧at Masqaţ and 1 other locations

• Sultan Qaboos University Hospital — Seeb, Muḩāfaz̧at Masqaţ, Oman (Recruiting)
• Prince Muhammad bin Nasser Hospital — Jizan, Saudi Arabia (Not_yet_recruiting)

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Conditions β-thalassemia; Transfusion-dependent β-thalassemia