Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 · View on ClinicalTrials.gov ↗
Study Summary
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).
Conditions Studied
Interventions
- BIOLOGICAL Luspatercept
- BIOLOGICAL Epoetin Alfa
Study Locations (20)
Florida
- Halifax Health Medical Center — Daytona Beach
- Local Institution - 0230 — Daytona Beach
- Florida Cancer Specialists - South — Fort Myers
- Baptist MD Anderson Cancer Center — Jacksonville
- Local Institution - 0224 — Margate
- BRCR Global — Plantation
- Florida Cancer Specialists - North — St. Petersburg
- Advanced Research — Tamarac
- Moffitt Cancer Center — Tampa
California
- Community Cancer Institute — Clovis
- Compassionate Cancer Care Medical Group — Fountain Valley
- Local Institution - 0095 — Fresno
- Cancer and Blood Specialty Clinic — Los Alamitos
- UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) — Los Angeles
- St. Joseph Hospital — Orange
- Ventura County Hematology Oncology Specialists — Oxnard
- John Muir Health - Behring Pavilion — Walnut Creek
Connecticut
- Hartford Hospital (HH) — Hartford
- Yale-New Haven Hospital — New Haven
Colorado
- Local Institution - 0098 — Fort Collins
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2023-10-24 |
| Est. Completion | 2030-03-11 |
| Phase | Phase 3 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05949684
The ClinicalTrials.gov registry entry for NCT05949684 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 504 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 2 interventions — of which Luspatercept is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05949684 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Florida, California, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05949684 about?
NCT05949684 is a clinical study titled "ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions". 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).
What is the current status of trial NCT05949684?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 360 participants. The study started on 2023-10-24. Estimated completion is 2030-03-11.
What conditions does trial NCT05949684 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05949684?
The interventions under investigation include: Luspatercept (BIOLOGICAL), Epoetin Alfa (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05949684?
This trial is sponsored by Bristol-Myers Squibb, which has 504 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05949684 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.