Linvoseltamab with pre-dose Tocilizumab to reduce CRS in adults with relapsed/refractory multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 trial investigates safety, tolerability, and preliminary effectiveness of linvoseltamab given after pre-treatment with tocilizumab in adults with relapsed or refractory multiple myeloma. Participants have received at least four prior lines of therapy, including a proteasome inhibitor, an IMiD, and an anti-CD38 antibody. The study aims to understand the impact of the pre-dose tocilizumab on CRS incidence and related healthcare needs, as well as other side effects and overall tolerability. Additional questions address whether corticosteroids or extra tocilizumab doses are needed and how these practices affect safety outcomes. The trial is conducted at multiple U.S. centers with Regeneron as lead sponsor.

Why it matters

Who can join: the full rules

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

Where it's running

• Berenson Cancer Center
  Los Angeles, California, United States Recruiting
• Comprehensive Hematology Oncology
  St. Petersburg, Florida, United States Recruiting
• Mary Bird Perkins Cancer Center
  Baton Rouge, Louisiana, United States Recruiting
• American Oncology Partners, PA dba The Center for Cancer and Blood Disorders
  Bethesda, Maryland, United States Recruiting
• Renown Health Medical Oncology
  Reno, Nevada, United States Recruiting
• Texas Tech University Health Science Center School of Medicine
  Lubbock, Texas, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.