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NCT Number: NCT07215975

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

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

Recruiting

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Key information

Conditions

β-thalassemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sultan Qaboos University Hospital, Seeb, Muḩāfaz̧at Masqaţ, Oman

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Luspatercept

Drug

According to the product label

Primary outcomes

  1. Change in transfusion burden

    Time frame: Baseline and up to week 144

  2. Change in mean pre-transfusion hemoglobin level

    Time frame: Baseline and up to week 144

Secondary outcomes

  1. Change in transfusion-related visits

    Time frame: Baseline and up to week 144

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

    Time frame: Baseline and up to week 144

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

    Time frame: Baseline and up to week 144

  4. Time from first luspatercept dosing date to the first erythroid response

    Time frame: Baseline and up to week 144

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

    Time frame: Baseline and up to week 144

  6. Participant pretransfusion hemoglobin level

    Time frame: Baseline and up to week 144

  7. Participant baseline transfusion burden

    Time frame: Baseline

  8. Proportion of participants without red blood cell transfusion during any consecutive 12-week or 24-week treatment period

    Time frame: Baseline and up to week 144

  9. Time from first luspatercept dosing date to first onset of red blood cell-transfusion independence ≥12 weeks and ≥24 weeks

    Time frame: Baseline and up to week 144

  10. Time from the date a 12-week and 24-week red blood cell-transfusion independence is first observed until the date the participant has a subsequently documented red blood cell transfusion

    Time frame: Baseline and up to week 144

  11. Change in mean serum ferritin (SF) level

    Time frame: Baseline and up to week 144

  12. Change in proportion of participants with mean serum ferritin <1,000, 1000-2500, and >2,500 μg/L

    Time frame: Baseline and up to week 144

  13. Types (drug formulation - mono and combination therapy) of iron chelation therapy received

    Time frame: Baseline and up to week 144

  14. Change in mean daily dose of iron chelation therapy from baseline

    Time frame: Baseline and up to week 144

  15. Number of medical encounters (inpatient hospitalizations, emergency department attendances, hospital outpatient visits, visits at office-based physicians)

    Time frame: Baseline and up to week 144

  16. Inpatient length of stay

    Time frame: Baseline and up to week 144

  17. Proportion of participants remaining on luspatercept treatment

    Time frame: Up to week 144

  18. Length of time from initiation to discontinuation of luspatercept treatment

    Time frame: Up to week 144

  19. Frequencies of reasons for discontinuation of luspatercept treatment

    Time frame: Up to week 144

  20. Participant sociodemographics

    Time frame: Baseline

    Sociodemographics of participants such as age, sex, ethnicity, country of treatment, height, weight, and body mass index

  21. Participant disease characteristics

    Time frame: Baseline

    Disease characteristics of participants, describing age of diagnosis of β-thalassemia, genotype (β0/β0, non-β0/β0), splenectomy status (yes/no), pretransfusion hemoglobin level (mean of all documented), transfusion burden (total number of red blood cell units transfused).

  22. Participant comorbidities

    Time frame: Baseline

    Disease- and non-disease-related comorbid conditions

  23. Concomitant treatment(s) received

    Time frame: Baseline

    Disease-related best supportive care (BSC) and treatments for other comorbidities.

  24. Number of luspatercept doses administered

    Time frame: Up to week 144

  25. Number of luspatercept dose modifications

    Time frame: Up to week 144

  26. Frequencies of reasons for luspatercept dose modifications

    Time frame: Up to week 144

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Oct 14, 2025
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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