A Study to Evaluate Luspatercept Treatment Patterns and Outcomes in Erythropoiesis-Stimulating Agents-Naïve Patients With Lower-Risk Myelodysplastic Syndromes in the United States
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Phase
—
Status
Completed
Study type
Observational
Enrollment
418actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-08-22 | actual | When the study began enrolling |
| Primary completion | 2025-03-10 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-03-10 | actual | The whole study's end, after follow-up |
| First posted | 2025-02-28 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Myelodysplastic Syndromes
Interventions
- Drug: Luspatercept
- Drug: Erythropoiesis-stimulating agents
Primary outcomes
what the primary-completion date above is the date OFParticipant baseline demographics
measured Baseline
Participant baseline clinical characteristics
measured Baseline
Time from Lower Risk- myelodysplastic syndromes diagnosis to index treatment initiation
measured Baseline
Rationale for therapy selection
measured Baseline
Duration of index treatment
measured Up to 15 months
Treatment dose at treatment initiation and discontinuation
measured Up to 6 months
Treatment dose/dosing schedule changes, and treatment interruptions
measured Up to 12 months
Other supportive care therapies prescribed while on index treatment
measured Up to 15 months
Treatments prescribed post index treatment
measured Up to 15 months
Treatments for anemia management received after discontinuing the index treatment
measured Up to 15 months
Receipt of stem cell transplant at any time post index treatment
measured Up to 15 months
Participant red-blood cell (RBC) transfusion burden post index treatment
measured At 3-months, and up to 6 months
Hematologic improvement-erythroid (HI-E) response post index treatment
measured At 3-months, and up to 6 months
Progression to acute myeloid leukemia post index treatment
measured Up to 15 months
Progression to high-risk myelodysplastic syndromes per the International Prognostic Scoring System (IPSS) or its revised version (IPSS-R) criteria
measured Up to 15 months
Participant adverse events during and post index treatment
measured Up to 15 months
Overall survival (OS)
measured At 3-, 6-, 12-, and up to 15-months
Healthcare resource utilization (HCRU) during index treatment
measured Up to 15 months
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