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915 Participants NeededMy employer runs this trial

Linvoseltamab + Carfilzomib for Multiple Myeloma

(LINKER-MM5 Trial)

Recruiting at 15 trial locations
CT
Overseen ByClinical Trials Administrator
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Regeneron Pharmaceuticals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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)

Who Is on the Research Team?

CT

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

Inclusion Criteria

I am able to care for myself and do light activities.
I have relapsed or refractory multiple myeloma and had 1-3 prior treatments, including lenalidomide and a PI or anti-CD38 antibody.
My disease has gotten worse during or after my last treatment.

Exclusion Criteria

I have a history of a brain or nerve disease like PML or a movement disorder.
I have been diagnosed with plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome.
My myeloma has spread to my brain or spinal cord.
See 1 more

What Are the Treatments Tested in This Trial?

Interventions

  • Carfilzomib
  • Linvoseltamab

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Group I: Part 2: Arm CExperimental Treatment5 Interventions
Group II: Part 2: Arm BExperimental Treatment2 Interventions
Group III: Part 2: Arm AExperimental Treatment1 Intervention
Group IV: Part 1: Arm BExperimental Treatment2 Interventions
Group V: Part 1: Arm AExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

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