今天是:2019-11-23 星期六

硼替佐米联合地塞米松治疗具有肾脏意义的单克隆丙种球蛋白血症的临床研究
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注册号:

Registration number:

ChiCTR1900026355 

最近更新日期:

Date of Last Refreshed on:

2019-10-02 

注册时间:

Date of Registration:

2019-10-02 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

硼替佐米联合地塞米松治疗具有肾脏意义的单克隆丙种球蛋白血症的临床研究 

Public title:

Bortezomib plus dexamethasone in monoclonal gammopathy of renal significance 

注册题目简写:

VD方案治疗MGRS的临床研究 

English Acronym:

VD in MGRS 

研究课题的正式科学名称:

硼替佐米联合地塞米松治疗具有肾脏意义的单克隆丙种球蛋白血症的临床研究 

Scientific title:

Bortezomib plus dexamethasone in monoclonal gammopathy of renal significance 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

黄蓓晖 

研究负责人:

李娟 

Applicant:

Beihui Huang 

Study leader:

Juan Li 

申请注册联系人电话:

Applicant telephone:

+86 13570223456 

研究负责人电话:

Study leader's telephone:

+86 13719209240 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

hbh_st@126.com 

研究负责人电子邮件:

Study leader's E-mail:

hbh_st@126.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

广东省广州市中山二路58号 

研究负责人通讯地址:

广东省广州市中山二路58号 

Applicant address:

58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China 

Study leader's address:

58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

510080 

研究负责人邮政编码:

Study leader's postcode:

510080 

申请人所在单位:

中山大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital, Sun Yat-Sen University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2019[228] 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

中山大学附属第一医院临床科研和实验动物伦理委员会 

Name of the ethic committee:

ICE for Clinical Research and Animal Trials of the First Affiliated Hospital of Sun Yat-Sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-06-04 

伦理委员会联系人:

颜楚荣 

Contact Name of the ethic committee:

Churong Yan 

伦理委员会联系地址:

广东省广州市中山二路58号 

Contact Address of the ethic committee:

58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

中山大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital, Sun Yat-Sen University 

研究实施负责(组长)单位地址:

中山二路58号 

Primary sponsor's address:

58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

中山大学附属第一医院

具体地址:

中山二路58号

Institution
hospital:

The First Affiliated Hospital, Sun Yat-Sen University

Address:

58 Second Zhongshan Road, Yuexiu District

经费或物资来源:

无 

Source(s) of funding:

NO 

研究疾病:

多发性骨髓瘤 

Target disease:

multiple myeloma 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

1. 评估硼替佐米联合地塞米松方案治疗MGRS的血液学缓解率和器官缓解率。 2. 评估硼替佐米联合地塞米松方案治疗MGRS的安全性。 

Objectives of Study:

1. Evaluate hemotological response rate and organ response rate of VD in MGRS. 2. Evaluate safety of VD in MGRS. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. 年龄在18岁至75岁之间; 2. 符合国际肾脏病与单克隆免疫球蛋白病研究组专家共识MGRS诊断标准的患者(详见附录1),除外病理类型为AL淀粉样变性; 3. ECOG行为表现状态为0-3级; 4. 预计生存时间>6个月(详见附录2); 5. 无怀孕能力或在用药期间及停药90天内同意避孕的患者; 6. 理解并愿意参加本项临床试验并提供签署的知情同意书。 

Inclusion criteria

1. Aged 18-75 years. 2. MGRS according to the updated IKMGRG diagnostic criteria 2018. 3. EGCO 0-3 4. Estimated survival times over 6 months. 5. Meet the pregnancy prevention requirements: not of childbearing potential or agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug. 6. Able to provide written informed consent. 

排除标准:

1. 在最近3个月内参加过其他临床研究; 2. 有任何其它的恶性肿瘤病史; 3. 有严重感染或器质性疾病且疾病未控制的患者。 

Exclusion criteria:

1. Received other clinical trials for multiple myeloma within three months. 2. Prior or concurrent invasive malignancies. 3. Active systemic infection or any other medical or psychiatric condition which, in the opinion of the investigator, contraindicates the participant's participation in this study. 

研究实施时间:

Study execute time:

From2019-10-02To 2019-09-30 

干预措施:

Interventions:

组别:

1

样本量:

11

Group:

1

Sample size:

干预措施:

硼替佐米联合地塞米松化疗+一般肾脏治疗

干预措施代码:

Intervention:

Bortezomib plus dexamethasone +general kindey therapy

Intervention code:

组别:

2

样本量:

11

Group:

2

Sample size:

干预措施:

一般肾脏治疗

干预措施代码:

Intervention:

general kindey therapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

中山大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital, Sun Yat-Sen University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

血液学缓解率

指标类型:

主要指标 

Outcome:

hemotological response rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

器官缓解率

指标类型:

次要指标 

Outcome:

organ response rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

毒副作用

指标类型:

次要指标 

Outcome:

toxicity

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 75 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

由项目负责人委托对统计分析人员应用SAS软件((6.12版,SAS公司,Cary,NC)按照严格随机规程产生,给定种子数,产生**例受试者接受随机安排,列出流水号为001~***所对应的治疗分配。随机分配表由专职统计人员存储于安全数据库(Microsoft Office Access 2007)中保管。

Randomization Procedure (please state who generates the random number sequence and by what method):

The project director entrust statistics analyst using SAS software ((version 6.12, SAS, Cary, NC) produced under strict random codes, given the seed number, * * * * subjects to accept random arrangement, list the serial number is 001 ~***. The randomized form will save in Access.

盲法:

open label

Blinding:

open label

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

中山大学附属第一医院

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

The First Affiliated Hospital, Sun Yat-sen University

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

病例记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Case Record Form

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-10-02
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