A Real-World Study to Evaluate Luspatercept in 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

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

Study Overview

• Status: Recruiting
• Conditions: β-thalassemia
• Intervention / Treatment: Drug: Luspatercept

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain NCT # and Site #.
• Study Contact Backup: Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• Oman
  • Muḩāfaz̧at Masqaţ
    • Seeb, Muḩāfaz̧at Masqaţ, Oman, 123
      • Recruiting
      • Sultan Qaboos University Hospital
      • Contact: Salam Al Kindi, Site 301
• Saudi Arabia
  • Jizan, Saudi Arabia
    • Not yet recruiting
    • Prince Muhammad bin Nasser Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants receiving luspatercept treatment	Drug: Luspatercept; According to the product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in transfusion burden	Baseline and up to week 144
Change in mean pre-transfusion hemoglobin level	Baseline and up to week 144

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Participant pretransfusion hemoglobin level		Baseline and up to week 144
Participant baseline transfusion burden		Baseline
Proportion of participants without red blood cell transfusion during any consecutive 12-week or 24-week treatment period		Baseline and up to week 144
Time from first luspatercept dosing date to first onset of red blood cell-transfusion independence ≥12 weeks and ≥24 weeks		Baseline and up to week 144
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		Baseline and up to week 144
Change in mean serum ferritin (SF) level		Baseline and up to week 144
Change in proportion of participants with mean serum ferritin <1,000, 1000-2500, and >2,500 μg/L		Baseline and up to week 144
Types (drug formulation - mono and combination therapy) of iron chelation therapy received		Baseline and up to week 144
Change in mean daily dose of iron chelation therapy from baseline		Baseline and up to week 144
Number of medical encounters (inpatient hospitalizations, emergency department attendances, hospital outpatient visits, visits at office-based physicians)		Baseline and up to week 144
Inpatient length of stay		Baseline and up to week 144
Proportion of participants remaining on luspatercept treatment		Up to week 144
Length of time from initiation to discontinuation of luspatercept treatment		Up to week 144
Frequencies of reasons for discontinuation of luspatercept treatment		Up to week 144
Participant sociodemographics	Sociodemographics of participants such as age, sex, ethnicity, country of treatment, height, weight, and body mass index	Baseline
Participant disease characteristics	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).	Baseline
Participant comorbidities	Disease- and non-disease-related comorbid conditions	Baseline
Concomitant treatment(s) received	Disease-related best supportive care (BSC) and treatments for other comorbidities.	Baseline
Number of luspatercept doses administered		Up to week 144
Number of luspatercept dose modifications		Up to week 144
Frequencies of reasons for luspatercept dose modifications		Up to week 144

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Estimated): June 25, 2026
• Primary Completion (Estimated): February 28, 2030
• Study Completion (Estimated): April 17, 2031

Study Registration Dates

• First Submitted: October 9, 2025
• First Submitted That Met QC Criteria: October 9, 2025
• First Posted (Actual): October 14, 2025

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Transfusion-dependent β-thalassemia
• Additional Relevant MeSH Terms: luspatercept
• Other Study ID Numbers: CA056-1107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes