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Purpose

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)

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 NOTE: Other protocol defined inclusion/exclusion criteria apply

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1: Arm A
  • Drug: Linvoseltamab
    Administered per the protocol
    Other names:
    • REGN5458
    • Lynozyfic™
Experimental
Part 1: Arm B
  • Drug: Linvoseltamab
    Administered per the protocol
    Other names:
    • REGN5458
    • Lynozyfic™
  • Drug: Carfilzomib
    Administered per the protocol
    Other names:
    • Kyprolis®
Experimental
Part 2: Arm A
  • Drug: Linvoseltamab
    Administered per the protocol
    Other names:
    • REGN5458
    • Lynozyfic™
Experimental
Part 2: Arm B
  • Drug: Linvoseltamab
    Administered per the protocol
    Other names:
    • REGN5458
    • Lynozyfic™
  • Drug: Carfilzomib
    Administered per the protocol
    Other names:
    • Kyprolis®
Experimental
Part 2: Arm C
  • Drug: Carfilzomib
    Administered per the protocol
    Other names:
    • Kyprolis®
  • Drug: Daratumumab
    Administered per the protocol
    Other names:
    • Darzalex Faspro®
    • Darzalex®
  • Drug: Dexamethasone
    Administered per the protocol
    Other names:
    • Dexahexal®
  • Drug: Pomalidomide
    Administered per the protocol
    Other names:
    • Imnovid®
    • Pomalyst®
  • Drug: Bortezomib
    Administered per the protocol
    Other names:
    • Velcade®

Recruiting Locations

University of Texas Health Science Center, Houston
Houston, Texas 77030

More Details

Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.