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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegeneron Pharmaceuticals

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Known myeloma brain lesions or meningeal involvement

History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy [PML], or Central Nervous System (CNS) movement disorder

Trial design

Treatments tested in this trial

  • Linvoseltamab
  • Tocilizumab

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators