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Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS)

RecruitingPhase 4Ages 18 Years - anyAllRegeneron Pharmaceuticals
NCT07609940 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study is researching whether the use of tocilizumab before the first dose of linvoseltamab will decrease the risk of Cytokine Release Syndrome (CRS) in participants who have Relapsed or Refractory Multiple Myeloma (RRMM) who have already been treated with at least four lines of treatment for their multiple myeloma, including medicines called a proteasome inhibitor, an immunomodulatory drug, and an anti-Cluster of Differentiation (CD) 38 antibody. The aim of the study is to see how safe, tolerable and effective linvoseltamab is when given after tocilizumab. The study is looking at several other research questions, including: * What side effects may happen from taking tocilizumab before the first dose of linvoseltamab * Whether tocilizumab has an impact on CRS, including whether participants require hospital care and, if so, how many hospital visits occur and how long they last * H

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📋 Eligibility rules (as published)
Key Inclusion Criteria: 1. Disease progression on or after at least 4 prior lines of therapy including a(n) Protease Inhibitor (PI), Immunomodulatory imide Drug (IMiD), and anti-CD 38 antibody 2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2 3. Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy Key Exclusion Criteria: 1. Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes (POEMS) syndrome 2. Known myeloma brain lesions or meningeal involvement 3. History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy \[PML\], or Central Nervous System (CNS) movement disorder NOTE: Other protocol defined inclusion/exclusion criteria apply
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What it tests

  • Linvoseltamab
  • Tocilizumab
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Where

5 sites
Berenson Cancer Center
Los Angeles, United States
Comprehensive Hematology Oncology
St. Petersburg, United States
Mary Bird Perkins Cancer Center
Baton Rouge, United States
American Oncology Partners, PA dba The Center for Cancer and Blood Disorders
Bethesda, United States
Northwest Medical Specialties, PLLC
Tacoma, United States
🤝 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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