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

Официальное название

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

Обзор

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

Вмешательства

• Препарат Linvoseltamab
  Administered per the protocol
• Препарат Tocilizumab
  Administered per the protocol

Первичные конечные точки

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

Вторичные конечные точки (12)

• Occurrence of CRS of any grade [Срок оценки: Up to 12 months]
• Occurrence of recurrent CRS of any grade [Срок оценки: Up to 12 months]
• Occurrence of grade ≥2 CRS per ASTCT grading [Срок оценки: Up to 12 months]
• Occurrence of recurrent grade ≥2 CRS per ASTCT grading [Срок оценки: Up to 12 months]
• Occurrence of any grade infections per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 [Срок оценки: Up to 12 months]
• Occurrence of grade ≥3 infections per NCI-CTCAE version 5.0 [Срок оценки: Up to 12 months]
• Occurrence of any grade Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) per ASTCT grading [Срок оценки: Up to 12 months]
• Occurrence of grade ≥3 ICANS per ASTCT grading [Срок оценки: Up to 12 months]
• Occurrence of any grade neurotoxicity per NCI-CTCAE version 5.0 grading [Срок оценки: Up to 12 months]
• Occurrence of any grade neurotoxicity per ASTCT grading [Срок оценки: Up to 12 months]
• Occurrence of grade ≥3 neurotoxicity per NCI-CTCAE version 5.0 grading [Срок оценки: Up to 12 months]
• Occurrence of grade ≥3 neurotoxicity per ASTCT grading [Срок оценки: Up to 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Mary Bird Perkins Cancer Center — Baton Rouge
• Northwest Medical Specialties, PLLC — Tacoma

Идентификаторы

NCT: NCT07609940 · R5458-HM-2514

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗