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NCT05730036 · ClinicalTrials.gov registry record · Phase 3
A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma
A Phase 3 study of Relapsed Refractory Multiple Myeloma (RRMM), sponsored by Regeneron Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 410
- Enrollment target
- 20
- Study locations
NCT05730036 is a Phase 3 study of Relapsed Refractory Multiple Myeloma (RRMM) that is actively recruiting participants, run by Regeneron Pharmaceuticals. The registered enrollment target is 410 participants. The trial reports 20 study locations across 13 states.
The verdict
NCT05730036, a Phase 3 study of Relapsed Refractory Multiple Myeloma (RRMM), is actively recruiting participants, sponsored by Regeneron Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 410 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is researching an experimental drug called linvoseltamab, also called REGN5458. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had failed. These participants were no longer benefiting from standard medications and had no good treatment options. In that study, some participants who were treated with linvoseltamab had improvement of their myeloma (shrinkage of their tumors), including some participants who had complete responses (that is, the treatment got rid of all evidence of myeloma in their bodies). This study is focused on participants who have multiple myeloma that has returned or needs to be treated again after one to four prior treatments and have standard cancer treatment options available to them. The aim of this study is to see how safe and effective linvoseltamab is compared to a combination of three cancer drugs: elotuzumab, pomalidomide and dexamethasone, (called EPd) in participants who have returned after having received prior treatment that included lenalidomide, a proteosome inhibitor, and (for participants in some countries) a cluster of differentiation 38 (CD38) antibody. Half of the participants in this study will get linvoseltamab, and the other half will get EPd. This study is looking at several other research questions, including: * How long participants benefit from receiving linvoseltamab compared with EPd * How many participants treated with linvoseltamab or EPd have improvement of their multiple myeloma and by how much * What side effects happen from taking linvoseltamab compared to EPd * How long participants live while receiving treatment or after treatment with linvoseltamab compared to EPd * If there is any improvement in pain after treatment with linvoseltamab compared to EPd
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Pomalidomide
- DRUG Linvoseltamab
- DRUG Elotuzumab
Study Locations (20)
Victoria
- St Vincent's Hospital - Fitzroy
- University Hospital Geelong - Geelong
- Austin Hospital - Heidelberg
Kentucky
- University of Kentucky, Markey Cancer Center Clinical Research Organization - Lexington
- Norton Cancer Institute - Louisville
North Carolina
- Levine Cancer Center - Charlotte
- Duke University Medical Center - Durham
New South Wales
- Royal Prince Alfred Hospital - Camperdown
- Royal North Shore Hospital - St Leonards
Queensland
- Icon Cancer Centre - Wesley - Auchenflower
- Royal Brisbane and Women's Hospital - Herston
Tasmania
- Royal Hobart Hospital - Hobart
- Launceston General Hospital - Launceston
California
- University of California Los Angeles (UCLA) - Los Angeles
Florida
- University of Florida Division of Sponsored Programs - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 410 participants |
| Start Date | 2023-09-18 |
| Est. Completion | 2033-04-19 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05730036
The ClinicalTrials.gov registry entry for NCT05730036 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 410 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Relapsed Refractory Multiple Myeloma (RRMM) appearing as the primary indexed condition, and to 4 interventions - of which Dexamethasone is the first listed.
NCT05730036 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Victoria, Kentucky, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05730036 about?
NCT05730036 is a clinical study titled "A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma". This study is researching an experimental drug called linvoseltamab, also called REGN5458. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had f...
What is the current status of trial NCT05730036?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 410 participants. The study started on 2023-09-18. Estimated completion is 2033-04-19.
What conditions does trial NCT05730036 study?
This clinical trial studies the following conditions: Relapsed Refractory Multiple Myeloma (RRMM).
What interventions are being tested in trial NCT05730036?
The interventions under investigation include: Dexamethasone (DRUG), Pomalidomide (DRUG), Linvoseltamab (DRUG), Elotuzumab (DRUG).
Who is sponsoring clinical trial NCT05730036?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05730036 being conducted?
This trial has 20 study locations across California, Florida, Kentucky, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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