drugset / Trial / 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

NCT05949684

Phase 3 Active not recruiting 402 enrolled Bristol-Myers Squibb
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2023-10-24
Primary completion
2028-03-24
Completion
2031-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Luspatercept Protein / enzyme biologic
Comparator epoetin alfa Protein / enzyme biologic