Myelodysplastic SyndromesNCT07075406
A Study to Evaluate Treatment Patterns, Outcomes, and Healthcare Resource Utilization in Patients With Lower-Risk Myelodysplastic Syndromes Treated With Luspatercept
An observational study of Myelodysplastic Syndromes, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to understand the treatment use of luspatercept in adults diagnosed with lower-risk myelodysplastic syndromes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- Luspatercept
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 adults diagnosed with lower-risk myelodysplastic syndromes (LR-MDS) who have been initiated luspatercept treatment in US, Germany, Spain, France and Canada
Who may be able to join
- Confirmed diagnosis of primary myelodysplastic syndromes (MDS) with lower-risk status as measured by the International Prognostic Scoring System (IPSS) or the Revised International Prognostic Scoring System (IPSS-R) at the time of diagnosis
- IPSS risk level: low, intermediate-1 (level-1 risk)
- IPSS-R risk level: very low, low, intermediate
- Initiated luspatercept for treatment of Lower-Risk (LR)-MDS after the initial availability in each country of interest
- US: after April 2020
- Germany: after June 2020
Show all 12Show fewer
- Spain: after June 2020
- France: after June 202
- Canada: after February 2021
- The participant has a potential follow-up of at least 6 months from the index date (except death)
- The participant is aged 18 years or older at the index date
- The participant has a complete medical record or history for at least 12 months before the index date (or up to the date of initial LR-MDS diagnosis if duration between initial diagnosis and index date is less than 12 months)
Who cannot join
- Received luspatercept as part of a clinical trial
- The participant has evidence of other malignant neoplasms prior to diagnosis of MDS, except disease free for ≥ 5 years at time of MDS diagnosis, basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, or incidental histologic finding of prostate cancer (stage T1a or T1b)
- The participant has a history of Acute Myeloid Leukemia prior to MDS diagnosis
- The participant has participated in clinical trials for specific treatments related to treatment of MDS
Trial locations and contacts
1 site in 1 country.
United States1 site
RTI Health Solutions
Research Triangle Park, North Carolina, 27709-2194
About this study
Official title: Real-world Utilization Patterns, Clinical Outcomes, and HCRU in Lower-risk MDS Patients Treated With Luspatercept: A Multinational Medical Record Review Study
The purpose of this study is to understand the treatment use of luspatercept in adults diagnosed with lower-risk myelodysplastic syndromes
- Conditions
- Myelodysplastic Syndromes
- Being tested
- Luspatercept
- Keywords
- Lower-risk myelodysplastic syndromes (LR-MDS)
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuspaterceptDrug
According to 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.
Participant baseline demographics
Measured: Baseline
Participant baseline clinical characteristics
Measured: Baseline
Participant treatment history
Measured: Baseline
Secondary outcomes (9)
Number of participants receiving myelodysplastic syndromes (MDS) -directed treatment modalities
MDS-directed treatment modalities include:
- Therapies for treatment of anemia include
- Erythropoietin-stimulating agents (ESAs)
- Granulocyte-colony stimulating factors (G-CSFs
- Immunosuppressant/Immunomodulatory agents
- Hypomethylating agents
- Erythroid maturation agent
- Other MDS-directed therapies
- Other supportive care therapies
- Antibiotic therapy
- Iron chelation therapy
- Nutritional support
Measured: Up to 12 months
Systemic therapy agent or combination of agents received by participants
Measured: Up to 12 months
Treating clinicians' rationale for prescribing treatment(s)
Measured: Up to 12 months
Time to treatment discontinuation
Measured: Up to 12 months
Duration of treatment
Measured: Up to 12 months
Reason(s) for treatment discontinuation
Measured: Up to 12 months
Treatment dosing characteristics
Dosage characteristics includes:
- Daily dose at treatment initiation
- Dosing frequency
- Dose modifications
- Reason(s) for dose modification
- Dose and dosing frequency at treatment discontinuation
Measured: Up to 12 months
Sequence of treatments prescribed to participants
Measured: Up to 12 months
Number and proportion of participants who received stem-cell transplant
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Nov 2024
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies 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
- Retrospective
- Enrolment
- 250 participants (actual)
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
- NCT07075406
- Sponsor's protocol ID
- CA056-1043
- Status last verified
- Aug 2025
- First submitted
- 11 Jul 2025
- Last updated
- 22 Aug 2025
- 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 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Utilization Patterns, Clinical Outcomes, and HCRU in Lower-risk MDS Patients Treated With Luspatercept: A Multinational Medical Record Review Study
- ClinicalTrials.gov ID
- NCT07075406
- Acronym / sponsor ID
- CA056-1043
- Conditions
- Myelodysplastic Syndromes
- Keywords
- Lower-risk myelodysplastic syndromes (LR-MDS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 20 Jul 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 understand the treatment use of luspatercept in adults diagnosed with lower-risk myelodysplastic syndromes
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- 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 adults diagnosed with lower-risk myelodysplastic syndromes (LR-MDS) who have been initiated luspatercept treatment in US, Germany, Spain, France and Canada
Key inclusion criteria (12 listed)
- Confirmed diagnosis of primary myelodysplastic syndromes (MDS) with lower-risk status as measured by the International Prognostic Scoring System (IPSS) or the Revised International Prognostic Scoring System (IPSS-R) at the time of diagnosis
- Initiated luspatercept for treatment of Lower-Risk (LR)-MDS after the initial availability in each country of interest
- The participant has a potential follow-up of at least 6 months from the index date (except death)
- The participant is aged 18 years or older at the index date
- The participant has a complete medical record or history for at least 12 months before the index date (or up to the date of initial LR-MDS diagnosis if duration between initial diagnosis and index date is less than 12 months)
Key exclusion criteria (4 listed)
- Received luspatercept as part of a clinical trial
- The participant has evidence of other malignant neoplasms prior to diagnosis of MDS, except disease free for ≥ 5 years at time of MDS diagnosis, basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, or incidental histologic finding of prostate cancer (stage T1a or T1b)
- The participant has a history of Acute Myeloid Leukemia prior to MDS diagnosis
- The participant has participated in clinical trials for specific treatments related to treatment of MDS
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 product label | Drug | Participants receiving luspatercept treatment |
Primary outcome
Participant baseline demographics
Time frame: Baseline
Participant baseline clinical characteristics
Time frame: Baseline
Participant treatment history
Time frame: Baseline
9 secondary outcomes
Number of participants receiving myelodysplastic syndromes (MDS) -directed treatment modalities
Time frame: Up to 12 months
Systemic therapy agent or combination of agents received by participants
Time frame: Up to 12 months
Treating clinicians' rationale for prescribing treatment(s)
Time frame: Up to 12 months
Time to treatment discontinuation
Time frame: Up to 12 months
Duration of treatment
Time frame: Up to 12 months
Reason(s) for treatment discontinuation
Time frame: Up to 12 months
Treatment dosing characteristics
Time frame: Up to 12 months
Sequence of treatments prescribed to participants
Time frame: Up to 12 months
Number and proportion of participants who received stem-cell transplant
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- 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. This study is not recruiting at the moment.
Bristol Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndromes, run by Bristol-Myers Squibb at 1 site in United States.
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 12 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: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant baseline demographics (time frame: Baseline). The study lists 3 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 22 Aug 2025.