N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Regeneron Pharmaceuticals • ClinicalTrials.gov ID: NCT07393282

Registry updated: 2026-10-21
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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)

Interventions

  • Linvoseltamab (Drug)
    Administered per the protocol
  • Daratumumab (Drug)
    Administered per the protocol

Eligibility criteria

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 Exclusion Criteria: 1. Evidence of myeloma-defining events attributable to the underlying plasma cell dyscrasia, as defined in the protocol 2. Diagnosis of systemic light chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), plasma cell leukemia, or soft tissue plasmacytoma 3. History of neurodegenerative condition, progressive multifocal leukoencephalopathy, or Central Nervous System (CNS) movement disorder 4. History of a seizure within the 12 months of randomization 5. Prior exposure to any approved or investigational treatments directed against a clonal plasma cell disorder (including but not limited to conventional chemotherapies, radiotherapy, immunomodulatory drugs, proteasome inhibitors, anti-CD38 antibodies). Ongoing treatment with other monoclonal antibodies (eg, infliximab, rituximab) or other treatments likely to interfere with study procedures or results, as described in the protocol. NOTE: Other protocol defined inclusion/exclusion criteria apply

Conditions

High Risk Smoldering Multiple Myeloma (HR-SMM)

Locations

  • Mayo Clinic Phoenix, Mayo Clinic Building — Phoenix, Arizona, United States
  • Emory University - Winship Cancer Institute — Atlanta, Georgia, United States
  • Dana Farber / Harvard Cancer Center — Boston, Massachusetts, United States
  • Barbara Ann Karmanos Cancer Institute - Detroit — Detroit, Michigan, United States
  • Mayo Clinic — Rochester, Minnesota, United States
  • Washington University School of Medicine in St. Louis — St Louis, Missouri, United States
  • Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • Columbia University Medical Center — New York, New York, United States
  • Ohio State University — Columbus, Ohio, United States
  • Nagoya City University Hospital — Nagoya, Aichi-ken, Japan
  • National Hospital Organization Okayama Medical Center — Okayama, Okayama-ken, Japan
  • Tokushima Prefectural Central Hospital — Tokushima, Tokushima, Japan
  • Yamanashi Prefectural Central Hospital — Kofu, Yamanashi, Japan
  • National Hospital Organization Matsumoto Medical Center — Matsumoto-shi, Japan
  • Pratia Onkologia Katowice — Katowice, Poland
  • The Catholic University of Korea, St Vincents Hospital — Suwon, Gyeonggi-do, South Korea
  • Chonnam National University Hwasun Hospital — Hwasun, Jeollanam-do, South Korea
  • Seoul National University Hospital — Seoul, South Korea
  • Severance Hospital, Yonsei University Health System — Seoul, South Korea
  • Asan Medical Center — Seoul, South Korea
  • Samsung Medical Center — Seoul, South Korea
  • Seoul St. Mary's Hospital, The Catholic University of Korea — Seoul, South Korea
  • Royal Cornwall Hospital — Truro, Cornwall, United Kingdom
  • Norfolk and Norwich University Hospital — Norwich, Norfolk, United Kingdom
  • University Hospitals Leicester — Leicester, United Kingdom
  • Saint Bartholomew's Hospital — London, United Kingdom
  • Hammersmith Hospital, Imperial College Healthcare NHS Trust — London, United Kingdom
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record