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
🩺 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: Review the eligibility criteria below.
Location: Local Institution - 0070 — Clovis, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 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
- A Study of Tebapivat (AG-946) in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes (LR-MDS) — Lakewood, California
- Inqovi Maintenance Therapy in Myeloid Neoplasms — Boston, Massachusetts
- Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) — Birmingham, Alabama
- CPX-351 (Vyxeos™) for Transplant Eligible, Higher Risk Patients With Myelodysplastic Syndrome — Tampa, Florida
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.