NCT07075406Completed
A Study to Evaluate Treatment Patterns, Outcomes, and Healthcare Resource Utilization in Patients With Lower-Risk Myelodysplastic Syndromes Treated With Luspatercept
Real-world Utilization Patterns, Clinical Outcomes, and HCRU in Lower-risk MDS Patients Treated With Luspatercept: A Multinational Medical Record Review Study
Source: ClinicalTrials.gov · Last updated 22 Aug 2025
Brief summary (registry, in English)
The purpose of this study is to understand the treatment use of luspatercept in adults diagnosed with lower-risk myelodysplastic syndromes
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 250 (actual)
- First submitted
- 11 Jul 2025
- Start date
- Nov 2024
- Primary completion date
- Aug 2025
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Myelodysplastic syndromes
- NCT number
- NCT07075406
What you commit to
- Study type: Observational
- Participants enrolled: 250
- From Nov 2024 to the primary completion date, Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- The participant has participated in clinical trials for specific treatments related to treatment of MDS
Who the study is looking for
- 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
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| RTI Health Solutions Coordinator of this site? Confirm its status | Research Triangle Park | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.