A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients 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

Linvoseltamab is administered by intravenous (IV) infusion

DRUG

Daratumumab

Daratumumab is administered by IV infusion and/or subcutaneous (SC) injection; SC injection may be used after a minimum of 2 cycles of IV administration at the investigator's discretion.

DRUG

Carfilzomib

Carfilzomib is administered by IV infusion

DRUG

Lenalidomide

Lenalidomide is administered by mouth (PO) as a capsule

DRUG

Bortezomib

Bortezomib is administered by IV infusion or SC injection

DRUG

Pomalidomide

Pomalidomide is administered by mouth (PO) as a capsule

DRUG

Isatuximab

Isatuximab is administered by IV infusion

DRUG

Fianlimab

Fianlimab is administered by IV infusion

DRUG

Cemiplimab

Cemiplimab is administered by IV infusion

DRUG

Nirogacestat

Nirogacestat is administered by mouth (PO) as a tablet

DRUG

Cevostamab

Cevostamab is administered by IV infusion

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

2028-04-11

Completion

2034-09-26

FDA Drug

Yes

Countries

• United States
• France
• Greece
• Israel
• Spain

Study Locations