Recruiting
Phase 3

Linvoseltamab & Carfilzomib

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT07222761

Conditions

Relapsed and/or Refractory Multiple Myeloma (RRMM)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Linvoseltamab

Carfilzomib

Daratumumab

Dexamethasone

Pomalidomide

Study Details

Brief 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)

Study ID

NCT07222761

Start date

Jan 2, 2026

Status verified date

Jun, 2026

Completion date

Aug 23, 2034

Anticipated

Primary completion date

May 21, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

915 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

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

Primary outcome measure

  • Occurrence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 5 years ]
  • Severity of TEAEs [ Time Frame: Up to 5 years ]
  • Occurrence of Adverse Events of Special Interest (AESI) [ Time Frame: Up to 5 years ]
  • Severity of AESIs [ Time Frame: Up to 5 years ]
  • Occurrence of Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
  • Severity of SAEs [ Time Frame: Up to 5 years ]
  • Minimal Residual Disease (MRD)-negative Complete Response (CR) [ Time Frame: At 12 months ]
  • Progression-Free Survival (PFS) per IMWG response criteria as determined by BIRC [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Emory Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10021

OhioHealth

Recruiting

Columbus, Ohio, United States, 43214

University of Texas Health Science Center, Houston

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • BCMA X CD3 Bispecific Monoclonal Antibody
  • Bispecific combination therapy
  • Linvoseltamab
  • Carfilzomib
  • Proteasome inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-07-01.