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

What's the purpose of 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. 

This trial is currently open and accepting patients.


What will happen during the trial?

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

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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

Additional Trial Information

Phase 4

Enrollment: 30 patients (estimated)

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Trial Locations

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Louisiana

Mary Bird Perkins Cancer Center

Baton Rouge, LA

Open and Accepting

Washington

Interested in this trial?
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