Spots Global Cancer Trial Database for A Study of Ninlaro in Real World Clinical Practice in China
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Trial Identification
Brief Title: A Study of Ninlaro in Real World Clinical Practice in China
Official Title: A National, Prospective, Non-interventional Study of NINLARO in Real World Clinical Practice
Study ID: NCT04328662
Interventions
Study Description
Brief Summary: The main purpose of this study is to collect additional safety information of ixazomib citrate (Ninlaro) when used to treat multiple myeloma in real world clinical practice in China. Participants will be treated with Ninlaro according to the normal clinical practice during this study.
Detailed Description: This is a prospective, non-interventional study in Chinese participants with relapsed refractory multiple myeloma (RRMM), newly diagnosed multiple myeloma (NDMM) and non-myeloma who are undergoing or will receive at least one dose of ixazomib citrate. Data will be collected to assess safety information when NINLARO is used in the real world, based on known risks and missing safety information. The study will enroll approximately 3000 patients. The data will be collected prospectively as part of routine clinical visits of participants. Participants will be assigned to one of the two observational cohorts: * Cohort 1: Participants with RRMM * Cohort 2: Participants with NDMM, RRMM, and Non-myeloma The multi-center trial will be conducted in China. The overall duration of study will be approximately 64 months. All participants will be followed up for 21 months unless withdrawal of Informed Consent Form, loss of follow-up or death, whichever comes first.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Anhui Cancer Hospital, Hefei, Anhui, China
Beijing Chao-yang Hospital,Capital Medical University, Beijing, Beijing, China
Peking University First Hospital, Beijing, Beijing, China
Beijing Jishuitan Hospital, Beijing, Beijing, China
Beijing Chao-yang Hospital,Capital Medical University(Shijingshan), Beijing, Beijing, China
Peking University Third Hospital, Beijing, Beijing, China
Peking Union Medical College Hospital, Beijing, Beijing, China
Sun Yat-Sen Memorial Hospital, Guangzhou, Guangdong, China
Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
Hainan General Hospital, Haikou, Hainan, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
Soochow Hongci Blood Disease Hospital, Suzhou, Jiangsu, China
Wuxi People's Hospital, Wuxi, Jiangsu, China
The First Bethune Hospital of Jilin University, Changchun, Jilin, China
The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China
The First Hospital of China Medical University, Shenyang, Liaoning, China
Affiliated Hospital of Jining Medical College, Jining, Shandong, China
Tai'an Central Hospital, Tai'an, Shandong, China
Zhabei Central Hospital, Jing'an District, Shanghai, Shanghai, Shanghai, China
Datong Third People's Hospital, Datong, Shanxi, China
Shanxi Provincial People's Hospital, Taiyuan, Shanxi, China
West China Hospital, Sichuan University, Chengdu, Sichuan, China
Tianjin Medical University General Hospital, Tianjin, Tianjin, China
Shaoxing People's Hospital, Shaoxing, Zhejiang, China
Taizhou First People's Hospital, Taizhou, Zhejiang, China
Contact Details
Name: Study Director
Affiliation: Takeda
Role: STUDY_DIRECTOR
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