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
- Diseases
- Multiple myeloma
- 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
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mary Bird Perkins Cancer Center Coordinator of this site? Confirm its status | Baton Rouge | United States | Recruiting |
| American Oncology Partners, PA dba The Center for Cancer and Blood Disorders Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
| Berenson Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Texas Tech University Health Science Center School of Medicine Coordinator of this site? Confirm its status | Lubbock | United States | Recruiting |
| Renown Health Medical Oncology Coordinator of this site? Confirm its status | Reno | United States | Recruiting |
| Comprehensive Hematology Oncology Coordinator of this site? Confirm its status | St. Petersburg | United States | Recruiting |
| Northwest Medical Specialties PLLC Coordinator of this site? Confirm its status | Tacoma | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.