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

A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) vs Epoetin Alfa for the Treatment of Anemia Due to Revised International Prognostic Scoring System (IPSS-R) Very Low, Low, or Intermediate-Risk Myelodysplastic Syndrome (MDS) in Erythropoiesis-Stimulating Agent (ESA)-Naive Participants Who Are Non-Transfusion Dependent (NTD): The "ELEMENT-MDS" Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD).

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
BIOLOGICAL	Luspatercept	Specified dose on specified days
BIOLOGICAL	Epoetin Alfa	Specified dose on specified days

Timeline

• Start date: 2023-10-24
• Primary completion: 2027-06-25
• Completion: 2030-03-11
• First posted: 2023-07-18
• Last updated: 2026-03-24

Locations

169 sites across 21 countries: United States, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Czechia, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Mexico, Poland, Puerto Rico, Spain

Regulatory

• FDA-regulated drug study