Who is eligible for clinical trial NCT05949684?

Participants must meet the protocol's inclusion criteria for Myelodysplastic Syndromes. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05949684 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-06-29

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)

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

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Bristol-Myers Squibb

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (6 items).

Location: Local Institution - 0070 — Clovis, California

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Participant has documented diagnosis of MDS according to World Health Organization (WHO) 2016 that meet IPSS-R classification of very low, low, or intermediate-risk disease, (intermediate-risk of ≤ 3.5 IPSS-R score) confirmed via bone marrow aspirate and:. i) \< 5% blasts in bone marrow and \< 1% blasts in peripheral blood.
Participant is not transfusion dependent (NTD) based on IWG2018 criteria.
Participant is erythropoiesis-stimulating agent naive. Participants may be randomized at the investigator's discretion if the participant received no more than 2 prior doses of epoetin alfa, epoetin alfa biosimilar, or darbepoetin alfa, with the last dose at least 8 weeks prior to randomization.
Participant has a baseline endogenous serum erythropoietin (sEPO) level of ≤ 500 U/L.
Participant has symptoms of anemia:. i) Participant records a severity score of "moderate" or greater on at least 1 PGI-S item of fatigue, weakness, shortness of breath, or dizziness performed during the screening period.
Participant has a baseline Hb concentration prior to randomization of ≤ 9.5 g/dL. The baseline Hb will be calculated using the mean of the two lowest available Hb measurements within 16 weeks prior to randomization and must include at least one central lab Hb reading done within the screening period (no more than 35 days before randomization). The two Hb measurements must have been performed at least seven days apart. Hb levels less than 21 days following RBC transfusion should not be used. Split samples for local assessments are not required.

Usually NOT eligible if any of the following apply:

Exclusion Criteria
Participant with secondary MDS (that is, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).
Participant with known history of diagnosis of AML.
Participant with history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis within 6 months prior to randomization.
Participant with a history of pure red cell aplasia and/or antibody against erythropoietin.
Other protocol-defined Inclusion/Exclusion criteria apply.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (144 Sites)

Showing the first 25 of 144 sites.

Local Institution - 0070 — Clovis, California
Local Institution - 0179 — Fountain Valley, California
Local Institution - 0211 — Los Alamitos, California
Local Institution - 0258 — Los Angeles, California
Local Institution - 0247 — Orange, California
Local Institution - 0209 — Oxnard, California
Local Institution - 0183 — Walnut Creek, California
Local Institution - 0227 — Hartford, Connecticut
Local Institution - 0173 — New Haven, Connecticut
Halifax Health Medical Center — Daytona Beach, Florida
Local Institution - 0202 — Fort Myers, Florida
Local Institution - 0180 — Jacksonville, Florida
Local Institution - 0224 — Margate, Florida
Local Institution - 0163 — Plantation, Florida
Local Institution - 0201 — St. Petersburg, Florida
Local Institution - 0238 — Tamarac, Florida
Local Institution - 0106 — Tampa, Florida
Local Institution - 0240 — Honolulu, Hawaii
Local Institution - 0272 — Chicago, Illinois
Local Institution - 0184 — Skokie, Illinois
Local Institution - 0270 — Dyer, Indiana
Local Institution - 0191 — Baton Rouge, Louisiana
Local Institution - 0044 — Covington, Louisiana
Local Institution - 0007 — Bethesda, Maryland
Local Institution - 0222 — Saint Louis Park, Minnesota

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Myelodysplastic Syndromes

Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA — Tampa, Florida
Ascorbate in Myelodysplastic Syndrome — Iowa City, Iowa
A Study of Tebapivat (AG-946) in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes (LR-MDS) — Lakewood, California
A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) — Hot Springs, Arkansas
Leflunomide in Combination With Decitabine for Treatment of Relapsed or Refractory Myelodysplastic Syndromes — Morgantown, West Virginia

Explore by condition: All Myelodysplastic Syndromes clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗