# ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions

> **NCT05949684** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Bristol-Myers Squibb** · enrollment: 360 (estimated)

## Conditions studied

- Myelodysplastic Syndromes

## Interventions

- **BIOLOGICAL:** Luspatercept
- **BIOLOGICAL:** Epoetin Alfa

## Key facts

- **NCT ID:** NCT05949684
- **Lead sponsor:** Bristol-Myers Squibb
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2023-10-24
- **Primary completion:** 2027-06-25
- **Final completion:** 2030-03-11
- **Target enrollment:** 360 (ESTIMATED)
- **Last updated:** 2026-05-05


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05949684

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05949684, "ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT05949684. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*