Status:
NOT_YET_RECRUITING
A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Relapsed and/or Refractory Multiple Myeloma (RRMM)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is researching a drug called linvoseltamab (also called "study drug") either given alone or in combination with another anti-myeloma drug called carfilzomib, compared to several standard tr...
Eligibility Criteria
Inclusion
- Key
- Participant with RRMM who received at least 1 but not more than 3 prior lines of therapy, which must have included treatment with lenalidomide and either a Protease Inhibitor (PI) or anti-CD38 monoclonal antibody
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
- Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy
- Key
Exclusion
- Prior treatment with a T cell-based immunotherapy targeting BCMA, including BCMA-directed bispecific antibodies, Bispecific T-cell Engagers (BiTEs), and Chimeric Antigen Receptor (CAR) T cells. Antibody-drug conjugates targeting BCMA (eg, belantamab mafodotin) are not excluded
- Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Known Central Nervous System (CNS) involvement of myeloma including meningeal involvement
- History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy (PML), or CNS movement disorder
- NOTE: Other protocol defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
January 29 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 20 2034
Estimated Enrollment :
915 Patients enrolled
Trial Details
Trial ID
NCT07222761
Start Date
January 29 2026
End Date
September 20 2034
Last Update
October 30 2025
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