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)
NCT ID: NCT07222761
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
915 participants
INTERVENTIONAL
2026-01-02
2034-09-17
Brief Summary
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The aim of this study is to see if the safety and efficacy of linvoseltamab alone or in combination with carfilzomib can deliver better outcomes (deeper and longer responses that help extend life) than standard treatment options.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1: Arm A
Linvoseltamab
Administered per the protocol
Part 1: Arm B
Linvoseltamab
Administered per the protocol
Carfilzomib
Administered per the protocol
Part 2: Arm A
Linvoseltamab
Administered per the protocol
Part 2: Arm B
Linvoseltamab
Administered per the protocol
Carfilzomib
Administered per the protocol
Part 2: Arm C
Carfilzomib
Administered per the protocol
Daratumumab
Administered per the protocol
Dexamethasone
Administered per the protocol
Pomalidomide
Administered per the protocol
Bortezomib
Administered per the protocol
Interventions
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Linvoseltamab
Administered per the protocol
Carfilzomib
Administered per the protocol
Daratumumab
Administered per the protocol
Dexamethasone
Administered per the protocol
Pomalidomide
Administered per the protocol
Bortezomib
Administered per the protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
3. Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy
Exclusion Criteria
2. 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)
3. Known Central Nervous System (CNS) involvement of myeloma including meningeal involvement
4. History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy (PML), or CNS movement disorder
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Gold Coast Hospital and Health Service
Southport, Queensland, Australia
Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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R5458-ONC-2246
Identifier Type: -
Identifier Source: org_study_id
2024-519504-27-00
Identifier Type: CTIS
Identifier Source: secondary_id
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