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

RecruitingPhase 3Ages 18 Years - anyAllRegeneron Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

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)

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Linvoseltamab
  • Daratumumab
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Where

27 sites
Mayo Clinic Phoenix, Mayo Clinic Building
Phoenix, United States
Emory University - Winship Cancer Institute
Atlanta, United States
Dana Farber / Harvard Cancer Center
Boston, United States
Barbara Ann Karmanos Cancer Institute - Detroit
Detroit, United States
Mayo Clinic
Rochester, United States
Washington University School of Medicine in St. Louis
St Louis, United States
Memorial Sloan Kettering Cancer Center
New York, United States
Columbia University Medical Center
New York, United States

…and 19 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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