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正在招募IV 期编号 NCT06409702

Treatment of High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection

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

China

药品与企业信息

其他名称:Kyprolis

Induction: ASCT:20mg/56mg/m2 ,D1,8,15,C2-4; non ASCT: 20mg/36mg/m2 ,D1,8,15,C2-4; Consolidation: ASCT: 56mg/m2 ,D1,8,15,C5-6; non ASCT: 36mg/m2 ,D1,8,15,C5-8; Maintenance: ASCT: 70mg/m2 ,D1,15; non-ASCT:56mg/m2 ,D1,15 After consolidation therapy, if MRD negativity is sustained for more than 1 year, carfilzomib will be discontinued

其他名称:Darzalex

28d/Cycle Induction: 16mg/kg, D1,8,15,22,C 2-3,16mg/kg, D1,15, C4; Consolidation: ASCT: 16mg/kg/d, D1,15,C5-6; non ASCT: 16mg/kg/d, D1,15,C5-8; Maintenance: 16mg/kg, D1,monthly After consolidation therapy, if MRD negativity is sustained for more than 1 year, daratumumab will be discontinued

28d/Cycle Induction: 25mg qd d1-21 C2-C4; Consolidation: ASCT: 10mg d1-21,C5-6; non ASCT: 25 mg d1-21,C5-8; Maintenance: 10mgqd D1-21 After consolidation therapy, if MRD negativity is sustained for more than 1 year, lenalidomide monotherapy will be maintained until disease progression

28d/Cycle Induction: ASCT:40mg qd, po/iv,D1,8,15,22,C2-4; non ASCT:20mg qd, po/iv,D1,8,15,22,C2-4; Consolidation: ASCT: 40mg qd, po/iv,D1,8,15,22,C5-6; non ASCT:20mg qd, po/iv,D1,8,15,22,C5-8

VRD for first-cycle induction therapy药物

其他名称:Bortezomib(V), Lenalidomide(R), Dexamethasone(D)

Induction: C1, 28d/cycle Bortezomib(V):1.3 mg/m2,H,d1、4、8、11; Lenalidomide(R):25mg,po. qd d1-14; Dexamethasone(D):20 mg,po/iv,D1,2, 4,5, 8,9, 11,12。

研发企业

The First Affiliated Hospital of Soochow University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。

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)

The goal of this study is to evaluate sustained MRD negativity for one year in DKRD induction \& consolidation therapy +/- ASCT in newly diagnosed high-risk multiple myeloma patients. It aims to evaluate the efficacy and safety of the combination regimen of Daratumumab in combination with carfilzomib, lenalidomide, and dexamethasone (DKRD) +/- ASCT for the treatment of patients with newly diagnosed high-risk multiple myeloma. Participants will receive bortezomib based induction therapy for one cycle, and then DKRD induction for 3 cycles(+ASCT), DKRD consolidation for 2-4 cycles, and DKR maintenance treatment(adjusted according to MRD negativity after consolidation therapy)

适应症

Newly DiagnosedHigh RiskMRDMultiple Myeloma

主动联系研究团队

总联系人(申办方/研究总部)

中国/港澳台研究中心

  • The First Affiliated Hospital of Soochow UniversitySuzhou,Jiangsu,China

问自己是否符合条件、如何预筛

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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: Treatment of High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection
ClinicalTrials.gov Identifier: NCT06409702
Sponsor: The First Affiliated Hospital of Soochow University
Investigational product: Carfilzomib, Daratumumab, Lenalidomide, Dexamethasone, VRD for first-cycle induction therapy

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:Treatment of High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection
试验编号:NCT06409702
申办方:The First Affiliated Hospital of Soochow University
研究药物:Carfilzomib、Daratumumab、Lenalidomide、Dexamethasone、VRD for first-cycle induction therapy

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 793877006@qq.com

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