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Clinical trial

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

NCT05949684 is registered in ClinicalTrials.gov with Bristol-Myers Squibb as lead sponsor.

NCT NCT05949684
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Bristol-Myers Squibb
Phase
Phase 3
Overall status
Active, not recruiting
Start date
October 24, 2023
Completion date
May 30, 2031
Enrollment
402 (actual)
Sites
144

Conditions

As the registry lists them; a condition with its own page is linked.

myelodysplastic syndromes