An Open-Label, Randomized Phase 3 Study of Linvoseltamab Monotherapy and Linvoseltamab Plus Carfilzomib Versus Standard of Care Combination Regimens in Patients With Relapsed/Refractory Multiple Myeloma

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Australia
Gold Coast Hospital and Health Service
RECRUITING
Southport
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2026-01-02
Estimated Completion Date: 2034-09-17
Participants
Target number of participants: 915
Treatments
Experimental: Part 1: Arm A
Experimental: Part 1: Arm B
Experimental: Part 2: Arm A
Experimental: Part 2: Arm B
Experimental: Part 2: Arm C
Related Therapeutic Areas
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov

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