New drug linvoseltamab aims to stall multiple myeloma in High-Risk patients

NCT ID NCT07393282

Recruiting now Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This phase 3 trial compares an experimental drug, linvoseltamab, to an existing drug, daratumumab, in 270 people with smoldering multiple myeloma at high risk of developing active multiple myeloma. The goal is to see if linvoseltamab can delay the disease longer. Participants will receive one of the two drugs, and researchers will monitor progression, side effects, and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: linvoseltamab (also called REGN5458, Lynozyfic™) and daratumumab (also called Darzalex Faspro®, Darzalex®)
What this could lead to: If linvoseltamab works better than daratumumab, it could delay or prevent active multiple myeloma in high-risk patients, potentially extending life without the disease progressing.
What could go wrong: This is an early-stage comparison; linvoseltamab may not prove superior, and side effects could be significant. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Smoldering Multiple Myeloma smoldering plasma cell myeloma plasma cell myeloma prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIGH RISK SMOLDERING MULTIPLE MYELOMA (HR-SMM)

Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

Dana Farber / Harvard Cancer Center
RECRUITING

Boston, Massachusetts, 02215, United States
Emory University - Winship Cancer Institute
RECRUITING

Atlanta, Georgia, 30322, United States