Tocilizumab given before linvoseltamab to reduce cytokine release syndrome in multiple myeloma
Tests tocilizumab before linvoseltamab in adults with relapsed or refractory multiple myeloma.
Plain-language title generated from the registry record
Registry title: Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS)
Key facts
- Where
- Baton Rouge, Bethesda, Los Angeles, Lubbock, Reno, St. Petersburg, and Tacoma, United StatesSee the 7 sites
- Phase
- Phase 4
Where in United States
- Mary Bird Perkins Cancer CenterBaton Rouge, United StatesTaking people
- American Oncology Partners, PA dba The Center for Cancer and Blood DisordersBethesda, United StatesTaking people
- Berenson Cancer CenterLos Angeles, United StatesTaking people
- Texas Tech University Health Science Center School of MedicineLubbock, United StatesTaking people
- Renown Health Medical OncologyReno, United StatesTaking people
- Comprehensive Hematology OncologySt. Petersburg, United StatesTaking people
- Northwest Medical Specialties PLLCTacoma, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Regeneron Pharmaceuticals
- Trial code
- NCT07609940
- Record updated
- 27 October 2026
- Original description
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.Read full original descriptionShow less
A Phase 4, Single-Arm, Multicenter Study of Prophylactic Tocilizumab in Participants With Relapsed/Refractory Multiple Myeloma Treated With Linvoseltamab in the Outpatient Setting
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 * How frequently other medications (for example, corticosteroids or additional doses of tocilizumab) are used to support participants' care if needed
Inclusion: 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; Eastern Cooperative Oncology Group (ECOG) performance status score ≤2; Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy.
Exclusion: 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; History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy [PML], or Central Nervous System (CNS) movement disorder; NOTE: Other protocol defined inclusion/exclusion criteria apply; Known myeloma brain lesions or meningeal involvement.