Trial intelligence / Profile preview

Linvoseltamab versus daratumumab in high-risk smoldering multiple myeloma

2025-523252-31-00Phase 3Authorised

Sponsor
Regeneron Pharmaceuticals
Start
Oct 2026
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes, T-cell Engagers → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics
Countries
13
01

Overview

Phase 3, randomised, open-label trial in smoldering multiple myeloma (SMM) comparing Linvoseltamab with Daratumumab (2 arms). Primary endpoints: Clinical progression-free survival and Biochemical progression-free survival. Planned start Oct 2026; status: authorised.

02

Drugs

linvoseltamabdaratumumab
03

Conditions

smoldering multiple myeloma (SMM)

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