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Recruiting Phase 3 NCT07222761

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)

Phase 3 – large-scale trial before approval
Conditions: Relapsed and/or Refractory Multiple Myeloma (RRMM)

Sponsor: Regeneron Pharmaceuticals

trial.available_in: БГ
Overview
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 treatments for progressive Multiple Myeloma (MM) after at least 1 but no more than 3 prior therapies. 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)
Who can participate
Key Inclusion Criteria: 1. 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 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 Key Exclusion Criteria: 1. 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 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 NOTE: Other protocol defined inclusion/exclusion criteria apply
Interventions
Linvoseltamab
DRUG
Carfilzomib
DRUG
Daratumumab
DRUG
Dexamethasone
DRUG
Pomalidomide
DRUG
Bortezomib
DRUG
Locations 14
Australia (1)
Gold Coast Hospital and Health Service
Southport , Queensland
South Korea (6)
Chonnam National University Hwasun Hospital
Hwasun , Jeollanam-do
Seoul National University Hospital
Seoul
Severance Hospital; Division of Hematology
Seoul
Samsung Medical Center
Seoul
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul
Ulsan University Hospital
Ulsan
United Kingdom (5)
Aberdeen Royal Infirmary
Aberdeen , Aberdeenshire
Ninewells Hospital and Medical School
Dundee
Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust
Norwich , Norfolk
University Hospitals Plymouth National Health Service (NHS) Foundation Trust - Hematology
Plymouth , Devon
Royal Cornwall Hospital National Health Service (NHS) Foundation Trust
Truro , Cornwall
United States (2)
OhioHealth
Columbus , Ohio
Memorial Sloan Kettering Cancer Center
New York , New York
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
02.01.2026
Completion date
17.09.2034
Registry ID
NCT07222761
Source
clinicaltrials.gov
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