A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Participants With Multiple Myeloma That is Resistant to Current Standard of Care Treatments

Summary

This study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has previously been studied as a single agent (without other cancer treatments) in participants with multiple myeloma that returned after prior therapies and needed to be treated again.

In the initial study, some participants treated with linvoseltamab had improvement of their myeloma, including complete responses (no evidence of myeloma in their bodies).

This study is the first time linvoseltamab will be combined with other cancer therapies.

The main goal is to understand if linvoseltamab can be given safely with other cancer treatments, and if so, what dose of linvoseltamab should be used for each combination.

The study is looking at several other research questions, including:

* How many participants treated with linvoseltamab in combination with each of the other cancer treatments have improvement of their multiple myeloma
* What side effects may happen from taking linvoseltamab together with another cancer treatment
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)

Conditions

• Multiple Myeloma

Interventions

DRUG

Linvoseltamab

Administered per the protocol

DRUG

Daratumumab

Administered per the protocol

DRUG

Carfilzomib

Administered per the protocol

DRUG

Lenalidomide

Administered per the protocol

DRUG

Bortezomib

Administered per the protocol

DRUG

Pomalidomide

Administered per the protocol

DRUG

Isatuximab

Administered per the protocol

DRUG

Fianlimab

Administered per the protocol

DRUG

Cemiplimab

Administered per the protocol

DRUG

Nirogacestat

Administered per the protocol

DRUG

Cevostamab

Administered per the protocol

Sponsors & Collaborators

• Regeneron Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-17

Primary Completion

2028-03-25

Completion

2032-03-24

FDA Drug

Yes

Countries

• United States
• France
• Greece
• Israel
• Spain

Study Locations