A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma (TRI Pro)
2026年8月27日 更新者：Janssen Research & Development, LLC
79635322MMY2002: Phase 2 Randomized, Double-blind, Placebo-controlled Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma
The purpose of this study is to find out whether giving a single dose of tocilizumab before treatment with ramantamig can help prevent or reduce the severity of cytokine release syndrome (CRS) within 28 days from ramantamig, compared to participants who receive placebo.
CRS is an acute inflammatory reaction that can occur during treatment and may be associated with flu-like or other systemic symptoms, such as fever and tiredness.
研究概览
研究类型
介入性
注册 (估计的)
230
阶段
- 阶段2
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
- 姓名：Study Contact
- 电话号码：844-434-4210
- 邮箱：Participate-In-This-Study1@its.jnj.com
学习地点
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Concord、澳大利亚、2139
- 招聘中
- Concord Repatriation General Hospital
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California
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Beverly Hills、California、美国、90211
- 招聘中
- Beverly Hills Cancer Center (BHCC)
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Buenos Aires、阿根廷、C1426ANZ
- 招聘中
- Instituto Alexander Fleming
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Buenos Aires、阿根廷、C1118
- 招聘中
- Hospital Aleman
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Córdoba、阿根廷、X5016KEH
- 招聘中
- Hospital Privado Centro Medico de Cordoba
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Ampang、马来西亚、68000
- 招聘中
- Hospital Ampang
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Johor Bharu、马来西亚、80100
- 招聘中
- Hospital Sultanah Aminah
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Kota Kinabalu、马来西亚、88586
- 招聘中
- Hospital Queen Elizabeth
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Kuching、马来西亚、93586
- 招聘中
- Sarawak General Hospital
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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
Inclusion criteria:
- Documented diagnosis of multiple myeloma (MM) as defined by the criteria: a. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria; b. Measurable disease at screening as assessed by local laboratory as defined in the protocol
- Received at least 1 prior lines of antimyeloma therapy
- Relapsed or refractory disease as defined: a. Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by the IMWG response criteria greater than (>) 60 days after cessation of treatment.; b. Refractory disease is defined as failure to achieve a response (that is, partial response or better) or confirmed PD by the IMWG response criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment
- Have an eastern cooperative oncology group (ECOG) performance status (PS) score of 0 to 2 at screening and immediately before the start of study treatment administration. Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (example, wheelchair-bound due to prior spinal cord injury) and not related to MM or associated therapy
- Have clinical laboratory values meeting the criteria specified in the protocol during the screening and within 1 day of the start of administration of study treatment
Exclusion criteria:
- Concurrent use of any other anticancer treatment (including non-palliative radiotherapy) or investigational agent
- Major surgery, (for example, requiring general anesthesia) within 2 weeks before first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
- Suspected or known allergies, hypersensitivity, or intolerance to ramantamig and tocilizumab or their excipients
- Presence of any of the following: a. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM); b. Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy; c. Any active malignancy other than MM that is considered at high risk of recurrence requiring systemic therapy
- Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
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：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Arm A: Tocilizumab + Ramantamig
Participants will receive tocilizumab alongwith ramantamig.
Ramantamig will be administered for a total treatment of finite duration, or until progressive disease (PD) or intolerable toxicity (whichever is earlier).
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Ramantamig will be administered as subcutaneous (SC) injection.
其他名称：
Tocilizumab will be administered as intravenous (IV) injection.
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安慰剂比较：Arm B: Placebo + Ramantamig
Participants will receive placebo (saline) alongwith ramantamig.
Ramantamig will be administered for a total treatment of finite duration, or until PD or intolerable toxicity (whichever is earlier).
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Ramantamig will be administered as subcutaneous (SC) injection.
其他名称：
Placebo (saline) will be administered as IV injection.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Percentage of Participants Alive and Free of Treatment-Emergent American Society for Transplantation and Cellular Therapy (ASTCT) Grade Greater Than or Equal to (>=) 2 Cytokine Release Syndrome (CRS)
大体时间：End of Day 28 from ramantamig dose
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Percentage of participants alive and free of treatment-emergent ASTCT Grade >=2 CRS without the use of intervening treatment for CRS of any grade by the end of Day 28 from ramantamig dose will be reported.
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End of Day 28 from ramantamig dose
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Participants with Treatment-Emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 by the End of Day 28 from Ramantamig Dose
大体时间：End of Day 28 from ramantamig dose
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Percentage of participants with treatment-emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 by the end of Day 28 from the ramantamig dose, respectively, will be reported.
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End of Day 28 from ramantamig dose
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Percentage of Participants with Treatment-Emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 During Ramantamig Treatment
大体时间：Up to 37 months
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Percentage of participants with treatment-emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 during ramantamig treatment will be reported.
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Up to 37 months
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Percentage of Participants with Re-occurrence of CRS with ASTCT Grade >=2 After the Initial Occurrence of Treatment-Emergent Grade >=2 CRS Event
大体时间：Up to approximately 3 years and 6 months
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Percentage of participants with re-occurrence of CRS with ASTCT Grade >=2 after the initial occurrence of treatment-emergent Grade >=2 CRS event will be reported.
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Up to approximately 3 years and 6 months
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Percentage of Participants with Re-occurrence of CRS for All Grades
大体时间：Up to approximately 3 years and 6 months
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Percentage of participants with re-occurrence of CRS for all Grades will be reported.
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Up to approximately 3 years and 6 months
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Overall Response Rate (ORR)
大体时间：Up to approximately 3 years and 6 months
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ORR is defined as the percentage of participants who achieve partial response (PR) or better prior to progressive disease (PD) or subsequent antimyeloma therapy, in accordance with the international myeloma working group (IMWG) criteria.
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Up to approximately 3 years and 6 months
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Complete Response (CR) or Better
大体时间：Up to approximately 3 years and 6 months
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CR or better rate is defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to PD or subsequent antimyeloma therapy, in accordance with the IMWG criteria.
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Up to approximately 3 years and 6 months
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Very Good Partial Response (VGPR) or Better
大体时间：Up to approximately 3 years and 6 months
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VGPR or better rate is defined as the percentage of participants achieving VGPR, CR or sCR prior to PD or subsequent antimyeloma therapy, in accordance with the IMWG criteria.
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Up to approximately 3 years and 6 months
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Duration of Response (DoR)
大体时间：Up to approximately 3 years and 6 months
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DoR is defined as the time interval between the date of initial documentation of a response (PR or better) to the date of first documented evidence of PD according to the IMWG response criteria or death due to any cause, whichever occurs first.
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Up to approximately 3 years and 6 months
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Time to Response (TTR)
大体时间：Up to approximately 3 years and 6 months
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TTR is defined as the time from the date of randomization to the date of first documentation of a confirmed response (PR or better) for participants who have PR or better as their best response.
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Up to approximately 3 years and 6 months
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Progression-Free Survival (PFS)
大体时间：Up to approximately 3 years and 6 months
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PFS is defined as the duration from the date of randomization to either PD or death, whichever comes first.
Disease progression will be determined according to the IMWG response criteria.
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Up to approximately 3 years and 6 months
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Time To Next Line of Therapy (TTNT)
大体时间：Up to approximately 3 years and 6 months
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TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment.
Death due to progressive disease without the start of any subsequent antimyeloma therapy will be considered as an event.
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Up to approximately 3 years and 6 months
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Time to the First Treatment-emergent Infection with Toxicity Grade >=3
大体时间：Up to approximately 3 years and 6 months
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Time to the first treatment-emergent infection with toxicity grade >=3 will be reported.
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Up to approximately 3 years and 6 months
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Percentage of Participants with Primary Immunoglobulin Replacement Therapy (IgRT) Prophylaxis Use
大体时间：Up to approximately 3 years and 6 months
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Percentage of participants with primary IgRT prophylaxis use will be reported.
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Up to approximately 3 years and 6 months
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Percentage of Participants with Secondary IgRT Prophylaxis Use or Without IgRT Prophylaxis Use
大体时间：Up to approximately 3 years and 6 months
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Percentage of participants with secondary IgRT prophylaxis use or without IgRT prophylaxis use will be reported.
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Up to approximately 3 years and 6 months
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Percentage of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity
大体时间：Up to approximately 3 years and 6 months
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An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product.
Any new or worsening AE occurring at or after the initial administration of study treatment through the day of last dose plus 30 days or prior to the start of subsequent antimyeloma therapy, whichever is earlier, or any follow-up AE (linked to an existing TEAE) with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent therapy, or any AE that is considered treatment-related regardless of the start date of the event, is considered to be treatment-emergent.
TEAEs will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0.
Severity scale ranges from Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, Grade 5= death related to adverse event.
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Up to approximately 3 years and 6 months
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Percentage of Participants with Abnormalities in Laboratory Parameters
大体时间：Up to approximately 3 years and 6 months
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Percentage of participants with abnormalities in laboratory parameters (serum chemistry and hematology) will be reported.
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Up to approximately 3 years and 6 months
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Percentage of Participants with Incidence of Adverse Events of Clinical Interests
大体时间：Up to approximately 3 years and 6 months
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Percentage of participants with incidence of adverse events of clinical interests such as cytopenia will be reported.
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Up to approximately 3 years and 6 months
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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。
调查人员
- 研究主任：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC
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6月30日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2030年11月8日
研究注册日期
首次提交
2026年5月11日
首先提交符合 QC 标准的
2026年5月11日
首次发布 (实际的)
2026年5月15日
研究记录更新
最后更新发布 (实际的)
2026年8月28日
上次提交的符合 QC 标准的更新
2026年8月27日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 79635322MMY2002 (其他标识符：Janssen Research & Development, LLC)
- 2025 (美国 NIH 拨款/合同：Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-524793-42 (EudraCT编号)
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
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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
在美国制造并从美国出口的产品
是的
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.