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Recruiting NCT07609940

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

Phase IV Interventional Relapsed/Refractory Multiple Myeloma (RRMM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Linvoseltamab, Tocilizumab.
Who it may be relevant to
Registry conditions: Relapsed/Refractory Multiple Myeloma (RRMM). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 4, Single-Arm, Multicenter Study of Prophylactic Tocilizumab in Participants With Relapsed/Refractory Multiple Myeloma Treated With Linvoseltamab in the Outpatient Setting

Overview

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

Interventions

  • Drug Linvoseltamab
    Administered per the protocol
  • Drug Tocilizumab
    Administered per the protocol

Primary outcome measures

  • Occurrence of any grade CRS per American Society for Transplantation and Cellular Therapy (ASTCT) grading [Time frame: Up to 28 days]
  • Severity of any grade CRS per ASTCT grading [Time frame: Up to 28 days]
Secondary outcome measures (12)
  • Occurrence of CRS of any grade [Time frame: Up to 12 months]
  • Occurrence of recurrent CRS of any grade [Time frame: Up to 12 months]
  • Occurrence of grade ≥2 CRS per ASTCT grading [Time frame: Up to 12 months]
  • Occurrence of recurrent grade ≥2 CRS per ASTCT grading [Time frame: Up to 12 months]
  • Occurrence of any grade infections per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 [Time frame: Up to 12 months]
  • Occurrence of grade ≥3 infections per NCI-CTCAE version 5.0 [Time frame: Up to 12 months]
  • Occurrence of any grade Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) per ASTCT grading [Time frame: Up to 12 months]
  • Occurrence of grade ≥3 ICANS per ASTCT grading [Time frame: Up to 12 months]
  • Occurrence of any grade neurotoxicity per NCI-CTCAE version 5.0 grading [Time frame: Up to 12 months]
  • Occurrence of any grade neurotoxicity per ASTCT grading [Time frame: Up to 12 months]
  • Occurrence of grade ≥3 neurotoxicity per NCI-CTCAE version 5.0 grading [Time frame: Up to 12 months]
  • Occurrence of grade ≥3 neurotoxicity per ASTCT grading [Time frame: Up to 12 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

NOTE: Other protocol defined inclusion/exclusion criteria apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Mary Bird Perkins Cancer Center — Baton Rouge
  • Northwest Medical Specialties, PLLC — Tacoma

Identifiers

NCT: NCT07609940 · R5458-HM-2514

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗