A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM)

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT07428369
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Multiple Myeloma (MM)

Eligibility Criteria

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

Interventions

  • Linvoseltamab — DRUG
    Administered per the protocol
  • Bortezomib — DRUG
    Administered per the protocol
  • Lenalidomide — DRUG
    Administered per the protocol
  • Daratumumab — DRUG
    Administered per the protocol
  • Dexamethasone — DRUG
    Administered per the protocol

Study Details

This study is focused on participants with Newly Diagnosed Multiple Myeloma (NDMM) who are eligible for high dose chemotherapy followed by Autologous Stem Cell Transplantation (ASCT). This study is evaluating a drug called linvoseltamab in combination with standard therapies for multiple myeloma called bortezomib (V) and lenalidomide (R). This combination is abbreviated as Linvo-VR. The aim of this study is to compare how well Linvo-VR, with and without ASCT, treats myeloma to how well the current standard of care regimen for NDMM treats myeloma. That current standard of care regimen includes the drugs daratumumab (D), bortezomib (V), lenalidomide (R), and dexamethasone (d). This combination is referred to as DVRd. The study is also evaluating if Linvo-VR treats myeloma well enough that ASCT is no longer needed with the first myeloma treatments. The study is looking at several other research questions, including: * What side effects may happen from taking linvoseltamab * How much linvoseltamab is in the blood at different times * Whether the body makes antibodies against the linvoseltamab (which could make the drug less effective or could lead to side effects)

Key Dates

Start date
Jun 5, 2026
Status verified
Feb 2026
Primary completion
May 21, 2038
Completion
May 21, 2038

Study Design

Enrollment
1,570 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Linvo-VR with ASCT
  • Experimental: Linvo-VR without ASCT
  • Active Comparator: DVRd with ASCT

Primary Outcome Measure

Occurrence of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to day 112 ]

Central Contacts

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