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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 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.
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).
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?
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, categorized as Phase 3. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 283-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (27% higher). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.
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