A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)

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A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)

Status
Active
Cancer Type
Multiple Myeloma
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT07393282
Protocol IDs
R5458-HM-24145 (primary)
NCI-2026-02950
2025-523252-31-00
Study Sponsor
Regeneron Pharmaceuticals, Inc.

Summary

This study is researching an experimental drug called linvoseltamab (also called "study
drug") compared to another drug called daratumumab, in participants with Smoldering
Multiple Myeloma (SMM), who are at a High Risk (HR) of developing active multiple
myeloma.

The aim of this study is to find out whether linvoseltamab is better than daratumumab in
delaying the development of MM.

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)

Eligibility

  1. Eastern Cooperative Oncology Group performance status score =1
  2. SMM diagnosis per IMWG criteria as defined in the protocol
  3. Meets HR-SMM criteria by 1 of the risk models as defined in the protocol Key

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.