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)

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 915 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Relapsed and/or Refractory Multiple Myeloma (RRMM)

Interventions

Type	Name	Description
DRUG	Linvoseltamab	Administered per the protocol
DRUG	Carfilzomib	Administered per the protocol
DRUG	Daratumumab	Administered per the protocol
DRUG	Dexamethasone	Administered per the protocol
DRUG	Pomalidomide	Administered per the protocol
DRUG	Bortezomib	Administered per the protocol

Timeline

• Start date: 2026-01-02
• Primary completion: 2029-06-15
• Completion: 2034-09-17
• First posted: 2025-10-30
• Last updated: 2026-04-08

Locations

13 sites across 4 countries: United States, Australia, South Korea, United Kingdom

Regulatory

• FDA-regulated drug study