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OncoMatch/Clinical Trials/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

Is NCT05949684 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Luspatercept and Epoetin Alfa for myelodysplastic syndromes.

Phase 3RecruitingBristol-Myers SquibbNCT05949684Data as of May 2026

Treatment: Luspatercept · Epoetin Alfa — 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).

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Extracted eligibility criteria

Cancer type

Myelodysplastic Syndrome

Disease stage

Required: Stage VERY LOW, LOW, INTERMEDIATE-RISK (≤ 3.5 IPSS-R SCORE) (IPSS-R)

meet IPSS-R classification of very low, low, or intermediate-risk disease, (intermediate-risk of ≤ 3.5 IPSS-R score)

Prior therapy

Cannot have received: erythropoiesis-stimulating agent (epoetin alfa, epoetin alfa biosimilar, darbepoetin alfa)

Exception: no more than 2 prior doses, last dose at least 8 weeks prior to randomization

Lab requirements

Blood counts

< 5% blasts in bone marrow; < 1% blasts in peripheral blood; baseline Hb concentration prior to randomization of ≤ 9.5 g/dL

< 5% blasts in bone marrow and < 1% blasts in peripheral blood. baseline Hb concentration prior to randomization of ≤ 9.5 g/dL

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Community Cancer Institute · Clovis, California
  • Compassionate Cancer Care Medical Group · Fountain Valley, California
  • Local Institution - 0095 · Fresno, California
  • Cancer and Blood Specialty Clinic · Los Alamitos, California
  • UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) · Los Angeles, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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