ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions
← catalyst calendarNCT05949684 · readout in 582 d
Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
402actual
Sites
144
Countries
Argentina, Australia, Brazil +16
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 | 2023-10-24 | actual | When the study began enrolling |
| Primary completion | 2028-03-24 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2031-05-30 | estimated | The whole study's end, after follow-up |
| First posted | 2023-07-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-30 | 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
- Biological: Luspatercept — also filed as BMS-986346, ACE-536, Reblozyl®
- Biological: Epoetin Alfa — also filed as Epogen®, PROCRIT®, BINOCRIT
Primary outcomes
what the primary-completion date above is the date OFNumber of participants with lower-risk non-transfusion dependent myelodysplastic syndromes (NTD-MDS) who converted to Transfusion Dependence (TD) during any continuous 16-week interval within the 96-week treatment period
measured Up to Week 96
Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 grams/deciliter (g/dL) in any continuous 16-week interval within the 48 week Treatment Period in the absence of transfusion
measured Up to Week 48
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