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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

915 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-02

Study Completion Date

2034-09-17

Brief Summary

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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)

Detailed Description

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Conditions

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Relapsed and/or Refractory Multiple Myeloma (RRMM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: Arm A

Group Type EXPERIMENTAL

Linvoseltamab

Intervention Type DRUG

Administered per the protocol

Part 1: Arm B

Group Type EXPERIMENTAL

Linvoseltamab

Intervention Type DRUG

Administered per the protocol

Carfilzomib

Intervention Type DRUG

Administered per the protocol

Part 2: Arm A

Group Type EXPERIMENTAL

Linvoseltamab

Intervention Type DRUG

Administered per the protocol

Part 2: Arm B

Group Type EXPERIMENTAL

Linvoseltamab

Intervention Type DRUG

Administered per the protocol

Carfilzomib

Intervention Type DRUG

Administered per the protocol

Part 2: Arm C

Group Type EXPERIMENTAL

Carfilzomib

Intervention Type DRUG

Administered per the protocol

Daratumumab

Intervention Type DRUG

Administered per the protocol

Dexamethasone

Intervention Type DRUG

Administered per the protocol

Pomalidomide

Intervention Type DRUG

Administered per the protocol

Bortezomib

Intervention Type DRUG

Administered per the protocol

Interventions

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Linvoseltamab

Administered per the protocol

Intervention Type DRUG

Carfilzomib

Administered per the protocol

Intervention Type DRUG

Daratumumab

Administered per the protocol

Intervention Type DRUG

Dexamethasone

Administered per the protocol

Intervention Type DRUG

Pomalidomide

Administered per the protocol

Intervention Type DRUG

Bortezomib

Administered per the protocol

Intervention Type DRUG

Other Intervention Names

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REGN5458 Lynozyfic™ Kyprolis® Darzalex Faspro® Darzalex® Dexahexal® Imnovid® Pomalyst® Velcade®

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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Australia South Korea

Central Contacts

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Clinical Trials Administrator

Role: CONTACT

844-734-6643

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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