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Study identifier: NCT05828511 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Multiple Myeloma  ·  Sponsor: Regeneron Pharmaceuticals

PhasePhase 1/Phase 2
Planned participants149
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 l…

This description comes directly from the study's public registry record.

Talk to the study team

Clinical Trials Administrator  ·  844-734-6643  ·  clinicaltrials@regeneron.com

Always discuss trial participation with your own doctor first.

Locations (32)

University of California Los Angeles (UCLA)Los Angeles, California, United StatesRecruiting
UC Irvine HealthOrange, California, United StatesRecruiting
Colorado Blood Cancer Institute/SCRIDenver, Colorado, United StatesRecruiting
Norton Cancer InstituteLouisville, Kentucky, United StatesRecruiting
Karmanos Cancer InstituteDetroit, Michigan, United StatesRecruiting
Rutgers Cancer Institute of New JerseyNew Brunswick, New Jersey, United StatesRecruiting
Perlmutter Cancer Center at NYU Langone Hospital - Long IslandMineola, New York, United StatesRecruiting
Perlmutter Cancer CenterNew York, New York, United StatesRecruiting
Columbia University _ New York PresbyterianNew York, New York, United StatesRecruiting
Stony Brook University HospitalStony Brook, New York, United StatesRecruiting
Levine Cancer InstituteCharlotte, North Carolina, United StatesRecruiting
Duke University Health System (DUHS)Durham, North Carolina, United StatesRecruiting

+ 20 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05828511