Smoldering Multiple Myeloma Clinical Trials

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A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Eastern Cooperative Oncology Group performance status score ≤1

• SMM diagnosis per IMWG criteria as defined in the protocol

• Meets HR-SMM criteria by 1 of the risk models as defined in the protocol

Locations
United States
Massachusetts
Dana Farber / Harvard Cancer Center
RECRUITING
Boston
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2026-05-21
Estimated Completion Date: 2033-07-27
Participants
Target number of participants: 270
Treatments
Experimental: Linvoseltamab
Active_comparator: Daratumumab
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov