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NCT05949684 · ClinicalTrials.gov registry record · Phase 3
ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions
A Phase 3 study of Myelodysplastic Syndromes, sponsored by Bristol-Myers Squibb.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 360
- Enrollment target
- 20
- Study locations
NCT05949684: Recruiting Phase 3 study of Myelodysplastic Syndromes, sponsored by Bristol-Myers Squibb.
NCT05949684 is a Phase 3 study of Myelodysplastic Syndromes that is actively recruiting participants, run by Bristol-Myers Squibb. The registered enrollment target is 360 participants, above the 283-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (27% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05949684, a Phase 3 study of Myelodysplastic Syndromes, is actively recruiting participants, sponsored by Bristol-Myers Squibb.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 360 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
TD is defined as ≥ 3 red blood cells (RBC) units/16 weeks assessed by International Working Group (IWG) 2018.
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 |
What NCT05949684 shows while recruiting
NCT05949684 is an interventional study that assigns participants to a tested intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, above the 283-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (27% higher).
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.
NCT05949684 names 20 study sites across 4 states, led by Florida, California, Connecticut.
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.
What interventions are being tested in trial NCT05949684?
The interventions under investigation include: Luspatercept (BIOLOGICAL), Epoetin Alfa (BIOLOGICAL).
Who is sponsoring clinical trial NCT05949684?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
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
Similar trials for Myelodysplastic Syndromes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05949684's enrollment target sits among peer trials
360 14th of 173 higher than 160 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions
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