Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS)

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT07609940
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Relapsed/Refractory Multiple Myeloma (RRMM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Jul 17, 2026
Status verified
May 2026
Primary completion
Oct 11, 2027
Completion
Dec 6, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Linvoseltamab

Primary Outcome Measure

Occurrence of any grade CRS per American Society for Transplantation and Cellular Therapy (ASTCT) grading [ Time Frame: Up to 28 days ]

Central Contacts