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NCT05949684 · ClinicalTrials.gov record · last posted 2026-06-30

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

Study acronym: ELEMENT-MDS
StatusActive, Not Recruiting
PhasePhase 3
Started2023-10-24
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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).

Protocol amendment history 6 changes detected by DataLookout

2026-07-01
Primary endpoint(s) modified
WasNumber of participants with lower-risk non-transfusion dependent myelodysplastic syndromes (NTD-MDS) who converted to Transfusion Dependence (TD) during any continuous 16-week interval within the 96-week treatment period
NowNumber of participants with an increase from baseline in mean Hb values of ≥ 1.5 grams/deciliter (g/dL) in any continuous 16-week interval within the 48 week Treatment Period in the absence of transfusion, Number of participants with lower-risk non-transfusion dependent myelodysplastic syndromes (NTD-MDS) who converted to Transfusion Dependence (TD) during any continuous 16-week interval within the 96-week treatment period
2026-07-01
Enrollment increased: 360 → 402 participants
2026-07-01
Primary completion pushed: 2027-06-25 → 2028-03-24
2026-07-01
Completion pushed: 2030-03-11 → 2031-05-30
2026-05-06
Trial status changed: Recruiting → Active, Not Recruiting
2026-05-06
Trial sites reduced: 169 → 144 locations
Trial Details
NCT Number NCT05949684
Lead Sponsor Bristol-Myers Squibb
Conditions Myelodysplastic Syndromes
Enrollment 402 participants
Start Date 2023-10-24
Primary Completion 2028-03-24 (estimated)
Study Completion 2031-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-30