A Real-World Study to Evaluate Luspatercept in Adults With Transfusion-Dependent Beta-Thalassemia in the Middle East

NCT07215975 | Recruiting FDA Drug

• 1 other identifier: CA056-1107
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this study is to evaluate luspatercept treatment in adults with transfusion-dependent beta-Thalassemia in the Middle East

Conditions

β-thalassemia

Keywords

Transfusion-dependent β-thalassemia

Outcome Measures

Primary Outcomes (2)

• Change in transfusion burden

  Baseline and up to week 144

• Change in mean pre-transfusion hemoglobin level

  Baseline and up to week 144

Secondary Outcomes (26)

• Change in transfusion-related visits

  Baseline and up to week 144

• Proportion of participants achieving ≥33% reduction in red blood cell (RBC) transfusion burden (number of RBC units transfused) plus a reduction of ≥2 units

  Baseline and up to week 144

• Proportion of participants achieving ≥50% reduction in red blood cell transfusion burden plus a reduction of ≥2 units

  Baseline and up to week 144

• Time from first luspatercept dosing date to the first erythroid response

  Baseline and up to week 144

• Time from the date the erythroid response is first observed until the last day of response

  Baseline and up to week 144

Study Arms (1)

Participants receiving luspatercept treatment

Drug: Luspatercept

Interventions

Luspatercept DRUG

According to the product label

Participants receiving luspatercept treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include adult patients with transfusion-dependent β-thalassemia (TDT) in the Middle East region who have initiated luspatercept treatment

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Sultan Qaboos University Hospital

Seeb, Muḩāfaz̧at Masqaţ, 123, Oman

RECRUITING

Prince Muhammad bin Nasser Hospital

Jizan, Saudi Arabia

NOT YET RECRUITING

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

luspatercept

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2025
• First Posted: October 14, 2025
• Study Start: February 26, 2026
• Primary Completion (Estimated): February 28, 2030
• Study Completion (Estimated): April 17, 2031
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1); OM (1)