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
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
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
主动联系研究团队
总联系人(申办方/研究总部)
- Chengcheng Fu793877006@qq.com15206138158
中国/港澳台研究中心
- The First Affiliated Hospital of Soochow UniversitySuzhou,Jiangsu,China
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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)
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?
- 把本页信息带给您的主治医生,评估是否适合参加。
- 点击下方按钮打开官方注册页,查看研究中心联系方式。
- 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)。