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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Luspatercept | Protein / enzyme biologic | — | — |
| Comparator | epoetin alfa | Protein / enzyme biologic | — | — |