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NCT07609940RecruitingPhase 4

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

Source: ClinicalTrials.gov · Last updated 27 Oct 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
30 (estimated)
First submitted
20 May 2026
Start date
15 Jul 2026
Primary completion date
11 Oct 2027
Lead sponsor
Regeneron Pharmaceuticals
NCT number
NCT07609940

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 30
  • From 15 Jul 2026 to the primary completion date, 11 Oct 2027
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Other

  • Known myeloma brain lesions or meningeal involvement

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mary Bird Perkins Cancer Center
Coordinator of this site? Confirm its status
Baton RougeUnited StatesRecruiting
American Oncology Partners, PA dba The Center for Cancer and Blood Disorders
Coordinator of this site? Confirm its status
BethesdaUnited StatesRecruiting
Berenson Cancer Center
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
Texas Tech University Health Science Center School of Medicine
Coordinator of this site? Confirm its status
LubbockUnited StatesRecruiting
Renown Health Medical Oncology
Coordinator of this site? Confirm its status
RenoUnited StatesRecruiting
Comprehensive Hematology Oncology
Coordinator of this site? Confirm its status
St. PetersburgUnited StatesRecruiting
Northwest Medical Specialties PLLC
Coordinator of this site? Confirm its status
TacomaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.