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

ConditionRelapsed/Refractory Multiple Myeloma (RRMM)
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Linvoseltamab

    Drug

    Administered per the protocol

  • Tocilizumab

    Drug

    Administered per the protocol

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: LinvoseltamabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Occurrence of any grade CRS per American Society for Transplantation and Cellular Therapy (ASTCT) grading

Time frame
Up to 28 days
2

Severity of any grade CRS per ASTCT grading

Time frame
Up to 28 days

Secondary outcomes

1

Occurrence of CRS of any grade

Time frame
Up to 12 months
2

Occurrence of recurrent CRS of any grade

Time frame
Up to 12 months
3

Occurrence of grade ≥2 CRS per ASTCT grading

Time frame
Up to 12 months
4

Occurrence of recurrent grade ≥2 CRS per ASTCT grading

Time frame
Up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regeneron Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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