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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT05828511
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Linvoseltamab — DRUG
    Linvoseltamab will be administered by intravenous (IV) infusion

Study Details

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).

Key Dates

Start date
Dec 19, 2023
Status verified
May 2026
Primary completion
Nov 2, 2035
Completion
Nov 2, 2035

Study Design

Enrollment
149 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 cohorts
    Linvoseltamab dose escalation (part A), dose expansion (part B), and evaluation of alternative step-up regimen (part C) for participants with NDMM who are treatment-naïve.
  • Experimental: Phase 2 - transplant ineligible cohort
    Transplant-ineligible participants, enrolled in dose expansion, will receive selected linvoseltamab regimen until disease progression as per protocol.
  • Experimental: Phase 2 - transplant eligible cohort
    Transplant-eligible participants, enrolled in dose expansion, will receive selected linvoseltamab regimen for a fixed duration of treatment as per protocol

Primary Outcome Measure

Incidence of Dose-Limiting Toxicities (DLTs) [ Time Frame: End of the Observation period; up to day 28 ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
University of California Los Angeles (UCLA)Los AngelesCalifornia90095-
UC Irvine HealthOrangeCalifornia92868-
Colorado Blood Cancer Institute/SCRIDenverColorado80218-
Norton Cancer InstituteLouisvilleKentucky40207-
Karmanos Cancer InstituteDetroitMichigan48201-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
Perlmutter Cancer Center at NYU Langone Hospital - Long IslandMineolaNew York11501-
Columbia University _ New York PresbyterianNew YorkNew York10032-
Perlmutter Cancer CenterNew YorkNew York10016-
Stony Brook University HospitalStony BrookNew York11794-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Duke University Health System (DUHS)DurhamNorth Carolina27705-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Los Angeles, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of California Los Angeles (UCLA)· Los Angeles, CAUC Irvine Health· Orange, CAColorado Blood Cancer Institute/SCRI· Denver, CONorton Cancer Institute· Louisville, KYKarmanos Cancer Institute· Detroit, MIRutgers Cancer Institute of New Jersey· New Brunswick, NJ

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