A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant

Sponsor
European Myeloma Network B.V.
Study ID
NCT06932562
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

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

Study Details

This study is researching an experimental drug called linvoseltamab. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (transplant-ineligible). The main purpose of this study is to compare the effect and safety of linvoseltamab with the effect and safety of the standard treatment.

Key Dates

Start date
Dec 23, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2036
Completion
Dec 31, 2036

Study Design

Enrollment
1,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control arm DRd
  • Experimental: Experimental Arm DRd+ linvolsetamab

Primary Outcome Measure

Minimal Residual Disease (MRD) [ Time Frame: up to 11 years ]

Central Contacts

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