ELEMENT-MDS
Phase 3 Clinical Trial Comparing Luspatercept VS Epoetin Alfa in Patients with Very Low – Intermediate Risk MDS Who Are Not Transfusion Dependent
What will happen during the trial?
This clinical trial is evaluating the drug luspatercept. If you choose to participate in the study, you will receive either luspatercept or epoetin alfa. This trial is randomized, which means that participants will be randomly assigned into either the luspatercept or epoetin alfa group.
You will receive the study treatment at your hospital or study site, or possibly at home (only if receiving epoetin alfa). Epoetin alfa will be administered by a nurse or other trained staff member. The study treatment will be administered via subcutaneous injection (injection under the skin) in your upper arm, abdomen, and/or thigh. Each injection will take less than one minute.
Participants receiving luspatercept will receive treatment every three weeks, and participants receiving epoetin alfa will receive treatment every week. Participants may remain on this study for up to two years (or longer), as long as they continue to receive benefit from treatment.
More Information
- Trial Status
- Accepting patients
- Trial Phase
- Phase 3
- Enrollment
- 360 patients (estimated)
- Sponsors
- Bristol Myers Squibb
- Tags
- Erythroid Maturation Agent (EMA), Erythropoiesis-Stimulating Agent (ESA), Red Blood Cell Stimulant, Randomization
- Trial Type
- Treatment
- Last Update
- 4 weeks ago
- SparkCures ID
- 1732
- NCT Identifier
- NCT05949684
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