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正在招募II 期编号 NCT07657312

Infliximab for Cytokine Release Syndrome Prophylaxis During Teclistamab or Talquetamab Therapy in Patients With Relapsed or Refractory Myeloma

报名条件(概要)

  • 年龄:18 Years – 不限
  • 性别:不限
  • 健康志愿者:不接受

完整入排标准请以官方页面为准。

开展国家/地区

United States

药品与企业信息

Biospecimen Collection治疗操作

其他名称:Biological Sample Collection、Biospecimen Collected、Sample Collection、Specimen Collection

Undergo blood sample collection

Bone Marrow Biopsy治疗操作

其他名称:Biopsy of Bone Marrow、Biopsy, Bone Marrow

Undergo bone marrow biopsy

Computed Tomography治疗操作

其他名称:CAT、CAT Scan、Computed Axial Tomography、Computerized Axial Tomography、Computerized axial tomography (procedure)、Computerized Tomography

Undergo PET-CT

Infliximab生物制品

其他名称:Avakine、cA2、Remicade、Remsima

Given IV

Positron Emission Tomography治疗操作

其他名称:Medical Imaging, Positron Emission Tomography、PET、PET Scan、Positron emission tomography (procedure)、Positron Emission Tomography Scan、Positron-Emission Tomography

Undergo PET-CT

Talquetamab生物制品

其他名称:Anti-CD3/Anti-GPRC5D Bispecific Monoclonal Antibody JNJ-64407564、GPRC5D x CD3 Bispecific Antibody JNJ-64407564、GPRC5D x CD3 DuoBody Antibody JNJ-64407564、GPRC5D/CD3 DuoBody Antibody JNJ-64407564、Humanized GPRC5D x CD3 DuoBody Antibody JNJ-64407564、JNJ 64407564

Given SC

其他名称:JNJ 64007957、JNJ-64007957、JNJ64007957、Teclistamab-cqyv、Tecvayli

Given SC

X-Ray Imaging治疗操作

其他名称:Conventional X-Ray、Diagnostic Radiology、Medical Imaging, X-Ray、Plain film radiographs、Radiographic Imaging、Radiographic imaging procedure (procedure)

Undergo x-ray

研发企业

Naresh Bumma研究机构/其他

试验官方登记的主要申办方;研究机构申办时会显示相应机构名称。

生产企业

公开药品批准资料或正式说明书暂未提供明确的生产企业信息。

合作机构

  • Janssen Research & Development, LLC企业
  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.企业

研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业;生产企业仅取自美国上市原研药说明书所列企业(不含仿制药),不作推测;仅在其他国家上市的药品暂无法显示。

研究简介(原文)

This phase II trial tests how well giving infliximab works for the prevention of cytokine release syndrome (CRS) during treatment with teclistamab or talquetamab in patients with multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). CRS and neurologic toxicity (damage to the nervous system which includes the brain, spinal cord, and nerves) are potential risks of treatment with talquetamab and teclistamab. CRS involves a release of a large amount of proteins into the bloodstream causing inflammation. This may cause changes in blood pressure and heartbeat, flu-like symptoms (nausea, fever, and chills), and/or affect the lung/liver/kidney function. It may also cause certain brain-related symptoms, such as dizziness, weakness, confusion, difficulty speaking, and/or decreased brain function (possible paralysis and/or coma). Infliximab is a drug that prevents the tumor necrosis factor-alpha (TNF-α) from working. TNF-α is a cytokine, or chemical messenger, that helps your immune system produce inflammation. Giving infliximab may work well for the prevention of cytokine release syndrome during treatment with teclistamab or talquetamab in patients with relapsed or refractory multiple myeloma.

适应症

Cytokine Release SyndromeRecurrent Multiple MyelomaRefractory Multiple Myeloma

主动联系研究团队

这项试验目前在中国大陆没有研究中心

这种情况下,直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药/扩展准入(由主治医生一同提出),或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。

查看完整申请路径与成功率说明 →

总联系人(申办方/研究总部)

研究中心联系方式

问自己是否符合条件、如何预筛

我的病情档案

管理档案

档案只保存在您自己的浏览器里,不会上传,任何人(包括本站)都看不到。

英文版(发给研究团队)

Dear Study Team,

I am a patient in China and I am interested in participating in your clinical trial:

Study Title: Infliximab for Cytokine Release Syndrome Prophylaxis During Teclistamab or Talquetamab Therapy in Patients With Relapsed or Refractory Myeloma
ClinicalTrials.gov Identifier: NCT07657312
Sponsor: Naresh Bumma
Investigational product: Biospecimen Collection, Bone Marrow Biopsy, Computed Tomography, Infliximab, Positron Emission Tomography

About me:
- Age: (please fill in)
- Sex: (please fill in)
- Confirmed diagnosis and stage: (please fill in)
- Biomarkers / genetic testing: not available
- Prior and current treatments: (please fill in)
- Performance status (ECOG): not assessed
- Current location: China
- Travel ability: (please fill in)

Could you please let me know:
1. Whether I might be eligible for this study;
2. Which site would be closest and most practical for me, and whether remote pre-screening is possible;
3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening.

I can provide English translations of my medical records. Thank you very much for your time and help.

Kind regards,
(your name)
(your email / phone with country code)

中文对照(供您核对)

尊敬的研究团队:

我是一位来自中国的患者,希望咨询参加以下临床试验的可能:

研究名称:Infliximab for Cytokine Release Syndrome Prophylaxis During Teclistamab or Talquetamab Therapy in Patients With Relapsed or Refractory Myeloma
试验编号:NCT07657312
申办方:Naresh Bumma
研究药物:Biospecimen Collection、Bone Marrow Biopsy、Computed Tomography、Infliximab、Positron Emission Tomography

我的基本情况:
- 年龄:(请填写)
- 性别:(请填写)
- 确诊疾病与分期:(请填写)
- 基因/标志物检测:暂无
- 既往及当前治疗:(请填写)
- 体能状态(ECOG):未评估
- 目前所在城市:中国
- 可前往范围:(请填写)

想请教三个问题:
1. 我是否可能符合本研究的入组标准?
2. 哪个中心对我最方便可行?能否远程预筛?
3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)?

我可以提供英文翻译版病历。感谢您的时间与帮助。

顺祝安康
(您的姓名)
(您的邮箱/带国际区号的电话)
用邮件客户端发送给 OSUCCCClinicaltrials@osumc.edu

提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。

下一步怎么做?

  1. 把本页信息带给您的主治医生,评估是否适合参加。
  2. 点击下方按钮打开官方注册页,查看研究中心联系方式。
  3. 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。
在 ClinicalTrials.gov 查看官方页面