此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2026年9月10日 更新者：Regeneron Pharmaceuticals

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

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

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

30

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • California
      • Los Angeles、California、美国、90069
        • 招聘中
        • Berenson Cancer Center
    • Louisiana
      • Baton Rouge、Louisiana、美国、70809
        • 招聘中
        • Mary Bird Perkins Cancer Center
    • Maryland
      • Bethesda、Maryland、美国、20817
        • 招聘中
        • American Oncology Partners, PA dba The Center for Cancer and Blood Disorders
    • Washington
      • Tacoma、Washington、美国、98405
        • 招聘中
        • NorthWest Medical Specialties, PLLC

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：林沃塞坦单抗
药品：Linvoseltamab
根据协议管理
其他名称：
  • REGN5458
  • Lynozyfic™
药品：Tocilizumab
根据协议管理
其他名称：
  • ACTEMRA®

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Occurrence of any grade CRS per American Society for Transplantation and Cellular Therapy (ASTCT) grading
大体时间：Up to 28 days
Up to 28 days
Severity of any grade CRS per ASTCT grading
大体时间：Up to 28 days
Up to 28 days

次要结果测量

结果测量
措施说明
大体时间
总生存期
大体时间：长达 12 个月
长达 12 个月
反应持续时间 (DOR)
大体时间：长达 12 个月
长达 12 个月
无进展生存期 (PFS)
大体时间：长达 12 个月
长达 12 个月
Occurrence of CRS of any grade
大体时间：Up to 12 months
Up to 12 months
Occurrence of recurrent CRS of any grade
大体时间：Up to 12 months
Up to 12 months
Occurrence of grade ≥2 CRS per ASTCT grading
大体时间：Up to 12 months
Up to 12 months
Occurrence of recurrent grade ≥2 CRS per ASTCT grading
大体时间：Up to 12 months
Up to 12 months
Occurrence of any grade infections per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
大体时间：Up to 12 months
NCI CTCAE grade 1 to 5 version 5.0
Up to 12 months
Occurrence of grade ≥3 infections per NCI-CTCAE version 5.0
大体时间：Up to 12 months
Up to 12 months
Occurrence of any grade Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) per ASTCT grading
大体时间：Up to 12 months
Up to 12 months
Occurrence of grade ≥3 ICANS per ASTCT grading
大体时间：Up to 12 months
Up to 12 months
Occurrence of any grade neurotoxicity per NCI-CTCAE version 5.0 grading
大体时间：Up to 12 months
Up to 12 months
Occurrence of any grade neurotoxicity per ASTCT grading
大体时间：Up to 12 months
Up to 12 months
Occurrence of grade ≥3 neurotoxicity per NCI-CTCAE version 5.0 grading
大体时间：Up to 12 months
Up to 12 months
Occurrence of grade ≥3 neurotoxicity per ASTCT grading
大体时间：Up to 12 months
Up to 12 months
Occurrence of any grade neutropenia per NCI-CTCAE version 5.0 grading
大体时间：Up to 12 months
Up to 12 months
Occurrence of grade ≥3 neutropenia per NCI-CTCAE version 5.0 grading
大体时间：Up to 12 months
Up to 12 months
Number of treatment doses of tocilizumab following at least 1 dose of linvoseltamab for the management CRS
大体时间：Up to 12 months
Up to 12 months
Number of treatment doses of corticosteroid following at least 1 dose of linvoseltamab for the management CRS
大体时间：Up to 12 months
Up to 12 months
Total duration of corticosteroid treatment following at least 1 dose of linvoseltamab for the management CRS
大体时间：Up to 12 months
Up to 12 months
Number of hospitalizations per participant treated with at least 1 dose of linvoseltamab
大体时间：Up to 12 months
Up to 12 months
Total length of each Adverse Event (AE)-related hospital stay
大体时间：Up to 12 months
Up to 12 months
Occurrence of Treatment-Emergent Adverse Events (TEAEs) in participants treated with at least 1 dose of linvoseltamab
大体时间：Up to 12 months
Up to 12 months
Severity of TEAEs in participants treated with at least 1 dose of linvoseltamab
大体时间：Up to 12 months
Up to 12 months
Occurrence of Adverse Events of Special Interest (AESI) in participants treated with at least 1 dose of linvoseltamab
大体时间：Up to 12 months
Up to 12 months
Severity of AESI in participants treated with at least 1 dose of linvoseltamab
大体时间：Up to 12 months
Up to 12 months
Occurrence of Serious Adverse Events (SAEs) in participants treated with at least 1 dose of linvoseltamab
大体时间：Up to 12 months
Up to 12 months
Severity of SAEs in participants treated with at least 1 dose of linvoseltamab
大体时间：Up to 12 months
Up to 12 months
Achievement of Partial Response or better (≥PR) per International Myeloma Working Group (IMWG) criteria
大体时间：Up to 12 months
Up to 12 months
Time To Response (TTR)
大体时间：Up to 12 months
Up to 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Regeneron Pharmaceuticals

调查人员

  • 研究主任：Clinical Trial Management、Regeneron Pharmaceuticals

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月15日

初级完成 (估计的)

2027年10月11日

研究完成 (估计的)

2028年12月6日

研究注册日期

首次提交

2026年5月20日

首先提交符合 QC 标准的

2026年5月20日

首次发布 (实际的)

2026年5月27日

研究记录更新

最后更新发布 (实际的)

2026年9月11日

上次提交的符合 QC 标准的更新

2026年9月10日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • R5458-HM-2514

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD 共享时间框架

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy

IPD 共享访问标准

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅