β-thalassemiaNCT07215975
A Real-World Study to Evaluate Luspatercept in Adults With Transfusion-Dependent Beta-Thalassemia in the Middle East
An observational study of β-thalassemia, run by Bristol-Myers Squibb at 13 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate luspatercept treatment in adults with transfusion-dependent beta-Thalassemia in the Middle East Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- β-thalassemia
- What is being tested?
- Luspatercept
- How many people
- 200 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 26 Jun 2026to 17 Apr 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
13 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
13 sites in 4 countries
Saudi Arabia6 sites, 6 recruiting
- Not yet recruiting
Local Institution - 109
Al Hofuf and Al Mubarraz, 36422
Site 109
- Recruiting
Prince Mohammed Bin Fahad Hospital
Al Qaţīf, 32654
Abdullah H. Al Zayed, Site 103
- Not yet recruiting
Local Institution - 106
Dammam, 32263
Site 106
- Not yet recruiting
Local Institution - 102
Jizan, 82943
Site 102
- Not yet recruiting
Local Institution - 105
Mecca, 24241
Site 105
- Recruiting
King Saud Medical Complex
Riyadh, 12746
Aleem Aamer, Site 101, +966502021897
Kuwait3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 202
Al Jahra, 00020
Site 202
- Not yet recruiting
Local Institution - 201
Andalusia, 70050
Site 201
- Not yet recruiting
Local Institution - 203
Kuwait City, 20001
Site 203
United Arab Emirates3 sites, 3 recruiting
- Recruiting
Sheikh Shakhbout Medical City (SSMC)
Abu Dhabi, Abu Dhabi Emirate, 11001
Hussni Al Hateeti, Site 502, 00971507160033
- Not yet recruiting
Local Institution - 501
Abu Dhabi, 0
Site 501
- Not yet recruiting
Local Institution - 503
Al Ain City, Abu Dhabi Emirate, 15258
Site 503
Oman1 site, 1 recruiting
- Recruiting
Sultan Qaboos University Hospital
Seeb, Muḩāfaz̧at Masqaţ, 123
Salam Al Kindi, Site 301
About this study
Official 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
The purpose of this study is to evaluate luspatercept treatment in adults with transfusion-dependent beta-Thalassemia in the Middle East
- Conditions
- β-thalassemia
- Being tested
- Luspatercept
- Keywords
- Transfusion-dependent β-thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuspaterceptDrug
According to the product label
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving luspatercept treatment | Not described Receives: Drug: Luspatercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in transfusion burden
Measured: Baseline and up to week 144
Change in mean pre-transfusion hemoglobin level
Measured: Baseline and up to week 144
Secondary outcomes (26)
Change in transfusion-related visits
Measured: 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
Measured: Baseline and up to week 144
Proportion of participants achieving ≥50% reduction in red blood cell transfusion burden plus a reduction of ≥2 units
Measured: Baseline and up to week 144
Time from first luspatercept dosing date to the first erythroid response
Measured: Baseline and up to week 144
Time from the date the erythroid response is first observed until the last day of response
Measured: Baseline and up to week 144
Participant pretransfusion hemoglobin level
Measured: Baseline and up to week 144
Participant baseline transfusion burden
Measured: Baseline
Proportion of participants without red blood cell transfusion during any consecutive 12-week or 24-week treatment period
Measured: 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
Measured: 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
Measured: Baseline and up to week 144
Change in mean serum ferritin (SF) level
Measured: Baseline and up to week 144
Change in proportion of participants with mean serum ferritin <1,000, 1000-2500, and >2,500 μg/L
Measured: Baseline and up to week 144
Types (drug formulation - mono and combination therapy) of iron chelation therapy received
Measured: Baseline and up to week 144
Change in mean daily dose of iron chelation therapy from baseline
Measured: Baseline and up to week 144
Number of medical encounters (inpatient hospitalizations, emergency department attendances, hospital outpatient visits, visits at office-based physicians)
Measured: Baseline and up to week 144
Inpatient length of stay
Measured: Baseline and up to week 144
Proportion of participants remaining on luspatercept treatment
Measured: Up to week 144
Length of time from initiation to discontinuation of luspatercept treatment
Measured: Up to week 144
Frequencies of reasons for discontinuation of luspatercept treatment
Measured: Up to week 144
Participant sociodemographics
Sociodemographics of participants such as age, sex, ethnicity, country of treatment, height, weight, and body mass index
Measured: 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).
Measured: Baseline
Participant comorbidities
Disease- and non-disease-related comorbid conditions
Measured: Baseline
Concomitant treatment(s) received
Disease-related best supportive care (BSC) and treatments for other comorbidities.
Measured: Baseline
Number of luspatercept doses administered
Measured: Up to week 144
Number of luspatercept dose modifications
Measured: Up to week 144
Frequencies of reasons for luspatercept dose modifications
Measured: Up to week 144
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start26 Jun 2026
- Primary completion28 Feb 2030 (estimated)
- Study completion17 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for β-thalassemiaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215975
- Sponsor's protocol ID
- CA056-1107
- Status last verified
- Aug 2026
- First submitted
- 9 Oct 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07215975
- Acronym / sponsor ID
- CA056-1107
- Conditions
- β-thalassemia
- Keywords
- Transfusion-dependent β-thalassemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- 28 Feb 2030 (estimated)
- Study completion
- 17 Apr 2031 (estimated)
- First posted
- 14 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate luspatercept treatment in adults with transfusion-dependent beta-Thalassemia in the Middle East
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving luspatercept treatment | – | Drug: Luspatercept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LuspaterceptAccording to the product label | Drug | Participants receiving luspatercept treatment |
Primary outcome
Change in transfusion burden
Time frame: Baseline and up to week 144
Change in mean pre-transfusion hemoglobin level
Time frame: Baseline and up to week 144
26 secondary outcomes
Change in transfusion-related visits
Time frame: 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
Time frame: Baseline and up to week 144
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
Time from first luspatercept dosing date to the first erythroid response
Time frame: Baseline and up to week 144
Time from the date the erythroid response is first observed until the last day of response
Time frame: Baseline and up to week 144
Participant pretransfusion hemoglobin level
Time frame: Baseline and up to week 144
Participant baseline transfusion burden
Time frame: Baseline
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
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
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
Change in mean serum ferritin (SF) level
Time frame: Baseline and up to week 144
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
Types (drug formulation - mono and combination therapy) of iron chelation therapy received
Time frame: Baseline and up to week 144
Change in mean daily dose of iron chelation therapy from baseline
Time frame: Baseline and up to week 144
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
Inpatient length of stay
Time frame: Baseline and up to week 144
Proportion of participants remaining on luspatercept treatment
Time frame: Up to week 144
Length of time from initiation to discontinuation of luspatercept treatment
Time frame: Up to week 144
Frequencies of reasons for discontinuation of luspatercept treatment
Time frame: Up to week 144
Participant sociodemographics
Time frame: Baseline
Participant disease characteristics
Time frame: Baseline
Participant comorbidities
Time frame: Baseline
Concomitant treatment(s) received
Time frame: Baseline
Number of luspatercept doses administered
Time frame: Up to week 144
Number of luspatercept dose modifications
Time frame: Up to week 144
Frequencies of reasons for luspatercept dose modifications
Time frame: Up to week 144
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol Myers Squibb study director
Bristol-Myers Squibb
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of β-thalassemia, run by Bristol-Myers Squibb at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Saudi Arabia, Kuwait, United Arab Emirates, Oman. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in transfusion burden (time frame: Baseline and up to week 144). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.