OncoMatch/Clinical Trials/NCT05828511
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
Is NCT05828511 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Linvoseltamab for multiple myeloma.
Treatment: Linvoseltamab — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: any therapy for MM
Exception: prior emergent or palliative radiation and up to 1 month of single-agent corticosteroids, with washout periods as per the protocol
No prior therapy for MM, with the exception of prior emergent or palliative radiation and up to 1 month of single-agent corticosteroids, with washout periods as per the protocol
Lab requirements
Blood counts
adequate bone marrow reserves as defined in the protocol
Kidney function
adequate renal function as defined in the protocol/institutional guidance
Liver function
adequate hepatic function as defined in the protocol/institutional guidance
Cardiac function
adequate cardiac function as defined in the protocol/institutional guidance
Participants must have evidence of adequate bone marrow reserves and hepatic, renal and cardiac function as defined in the protocol; adequate hepatic, renal, pulmonary and cardiac function to be considered transplant-eligible. The specific thresholds for adequate organ function are as per institutional guidance.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California Los Angeles (UCLA) · Los Angeles, California
- UC Irvine Health · Orange, California
- Colorado Blood Cancer Institute/SCRI · Denver, Colorado
- Norton Cancer Institute · Louisville, Kentucky
- Karmanos Cancer Institute · Detroit, Michigan
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