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A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM)

NCT07428369 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1570

Last updated 2026-02-23

No results posted yet for this study

Summary

This study is focused on participants with Newly Diagnosed Multiple Myeloma (NDMM) who are eligible for high dose chemotherapy followed by Autologous Stem Cell Transplantation (ASCT).

This study is evaluating a drug called linvoseltamab in combination with standard therapies for multiple myeloma called bortezomib (V) and lenalidomide (R). This combination is abbreviated as Linvo-VR.

The aim of this study is to compare how well Linvo-VR, with and without ASCT, treats myeloma to how well the current standard of care regimen for NDMM treats myeloma. That current standard of care regimen includes the drugs daratumumab (D), bortezomib (V), lenalidomide (R), and dexamethasone (d). This combination is referred to as DVRd. The study is also evaluating if Linvo-VR treats myeloma well enough that ASCT is no longer needed with the first myeloma treatments.

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

* What side effects may happen from taking linvoseltamab
* How much linvoseltamab is in the blood at different times
* Whether the body makes antibodies against the linvoseltamab (which could make the drug less effective or could lead to side effects)

Conditions

  • Multiple Myeloma (MM)

Interventions

DRUG

Linvoseltamab

Administered per the protocol

DRUG

Bortezomib

Administered per the protocol

DRUG

Lenalidomide

Administered per the protocol

DRUG

Daratumumab

Administered per the protocol

DRUG

Dexamethasone

Administered per the protocol

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-05
Primary Completion
2038-05-21
Completion
2038-05-21
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07428369 on ClinicalTrials.gov