A Study to Evaluate Treatment Patterns, Outcomes, and Healthcare Resource Utilization in Patients With Lower-Risk Myelodysplastic Syndromes Treated With Luspatercept
NCT ID: NCT07075406
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
250 participants
OBSERVATIONAL
2024-11-01
2025-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Participants receiving luspatercept treatment
Luspatercept
According to product label
Interventions
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Luspatercept
According to product label
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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RTI Health Solutions
Research Triangle Park, North Carolina, United States
Countries
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Related Links
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BMS Clinical Trial Information
FDA Safety Alerts and Recalls
Other Identifiers
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CA056-1043
Identifier Type: -
Identifier Source: org_study_id
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