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Clinical Trial ● Currently Recruiting Phase III NCT07393282

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

A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM) — Recruiting • Phase III • Cardiology / Cardiovascular • NCT07393282.

📅 07 Oct 2026 ⏱ 2 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase III
NCT ID
NCT07393282
Sponsor
Regeneron Pharmaceuticals
Start
2026-05-21
ClinicaliQ Trial Snapshot
  • A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM) — Recruiting • Phase III • Cardiology / Cardiovascular • NCT07393282.
  • Treatment being tested: Linvoseltamab (an experimental bispecific antibody) is being compared to daratumumab (an established monoclonal antibody) in patients with high-risk smoldering multiple myeloma to evaluate efficacy and safety in delaying or preventing progression to active disease.
  • Patient eligibility overview: The trial enrolls patients with smoldering multiple myeloma who meet high-risk criteria for progression to active disease, representing an intermediate disease stage where intervention before overt myeloma development may alter disease trajectory.
Use This Page For
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  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

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…

Eligibility Snapshot
  • Key Inclusion Criteria: 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

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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