Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS)
A Phase 4, Single-Arm, Multicenter Study of Prophylactic Tocilizumab in Participants With Relapsed/Refractory Multiple Myeloma Treated With Linvoseltamab in the Outpatient Setting
- Relapsed/Refractory Multiple Myeloma (RRMM)
At a glance
- Phase
- Phase 4
- Study type
- Interventional
- Sponsor
- Regeneron Pharmaceuticals
- Enrolment target
- 30
- Started
- 15 July 2026
- Main results due
- 11 October 2027
- Study sites
- 5
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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
Study sites(5)
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
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
Recruiting
Showing 5 of 5 sites. 5 of the 5 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07609940. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
Not the right study?
Answer three questions and see the studies recruiting near you, in plain language.
Find a study for me