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A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
NCT05828511 · View on ClinicalTrials.gov ↗
Study Summary
This study is researching an experimental drug called linvoseltamab (called "study drug"). The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are eligible for high dose chemotherapy with autologous stem cell transplantation (transplant-eligible) or ineligible for autologous stem cell transplantation (transplant-ineligible). The aim of this clinical trial is to study the safety, tolerability (how the body reacts to the drug), and effectiveness (tumor shrinkage) of linvoseltamab in study participants with NDMM as a first step in determining if the study drug has a role in the treatment of NDMM. This study consists of 2 phases: * In Phase 1 Parts A and B, the study drug will be given to participants to study the side effects of the study drug and to establish the regimen (initial doses and full dose) of the study drug to be given to participants in Phase 2. * In Phase 1 Part C, the study drug will be given to participants to study the side effects when using different initial doses of the study drug. * In Phase 2, the study drug will be given to more participants to continue to assess the side effects of the study drug and to evaluate the activity of the study drug to shrink the tumor (multiple myeloma) in participants with NDMM. The study is looking at several research questions, including: * What side effects may happen from taking linvoseltamab? * What the right dosing regimen is for linvoseltamab? * How many participants treated with linvoseltamab have improvement of their disease and for how long? * The effects of linvoseltamab study treatment before and after transplant * How much linvoseltamab is in the blood at different times? * Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects).
Conditions Studied
Interventions
- DRUG Linvoseltamab
Study Locations (20)
New York
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island — Mineola
- Perlmutter Cancer Center — New York
- Columbia University _ New York Presbyterian — New York
- Stony Brook University Hospital — Stony Brook
Other
- CHU De Lille — Lille
- Centre Hospitalier Universitaire (CHU) Montpellier — Montpellier
- Hopital Saint Louis — Paris
- University Hospitals Pitie Salpetriere - Charles Foix — Paris
California
- University of California Los Angeles (UCLA) — Los Angeles
- UC Irvine Health — Orange
North Carolina
- Levine Cancer Institute — Charlotte
- Duke University Health System (DUHS) — Durham
Île-de-France Region
- Hopital Prive d'Antony — Antony
- Hopital Necker — Paris
Colorado
- Colorado Blood Cancer Institute/SCRI — Denver
Kentucky
- Norton Cancer Institute — Louisville
Michigan
- Karmanos Cancer Institute — Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 149 participants |
| Start Date | 2023-12-19 |
| Est. Completion | 2035-11-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05828511
The ClinicalTrials.gov registry entry for NCT05828511 describes a study currently listed as recruiting. It is categorized as Phase 1, 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 149 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 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 Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention — of which Linvoseltamab 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: NCT05828511 reports 20 study locations spanning 11 distinct geographic areas — top geographies include New York, Other, California. 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 NCT05828511 about?
NCT05828511 is a clinical study titled "A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment". This study is researching an experimental drug called linvoseltamab (called "study drug"). The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are eligible for high dose chemotherapy with autologous stem cell transplantation (transplant-eligible) or ineligible for a...
What is the current status of trial NCT05828511?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 149 participants. The study started on 2023-12-19. Estimated completion is 2035-11-02.
What conditions does trial NCT05828511 study?
This clinical trial studies the following conditions: Multiple Myeloma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05828511?
The interventions under investigation include: Linvoseltamab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05828511?
This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05828511 being conducted?
This trial has 20 study locations across California, Colorado, Kentucky, Michigan, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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