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)

Part of paid clinical trials in New York, New York.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT07222761
Phase
PHASE3
Status
Recruiting
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Conditions

  • Relapsed and/or Refractory Multiple Myeloma (RRMM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Linvoseltamab — DRUG
    Administered per the protocol
  • Carfilzomib — DRUG
    Administered per the protocol
  • Daratumumab — DRUG
    Administered per the protocol
  • Dexamethasone — DRUG
    Administered per the protocol
  • Pomalidomide — DRUG
    Administered per the protocol
  • Bortezomib — DRUG
    Administered per the protocol

Study Details

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)

Key Dates

Start date
Jan 2, 2026
Status verified
May 2026
Primary completion
May 21, 2029
Completion
Aug 23, 2034

Study Design

Enrollment
915 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Occurrence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 5 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
OhioHealthColumbusOhio43214-

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By research site
Memorial Sloan Kettering Cancer Center· New York, NYOhioHealth· Columbus, OH

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