Study identification

PURI

https://redirect.ema.europa.eu/resource/44146

EU PAS number

EUPAS30733

Study ID

44146

Official title and acronym

C16050: A national, prospective, non-interventional study of using NINLARO® in real world clinical practice

DARWIN EU® study

No

Study countries

China

Study description

This is a non-interventional and prospective study in Chinese patients. This study will review the data of patients who are undergoing treatment with NINLARO (of less than 3 months from initial treatment with NINLARO) or to be prescribed with NINLARO to collect all patient safety information related to the post-marketing use of drug. The study will enroll approximately 3000 patients. The patients will be enrolled in 2 cohorts: Cohort 1 and Cohort 2. Cohort 1 will enroll patients with relapsed refractory multiple myeloma (RRMM) who have received at least one dose of lxazomib plus lenalidomide - low dose dexamethasone (IRd) treatment. Cohort 2 will enroll patients with newly diagnosed multiple myeloma (NDMM) patients who have received at least one dose of Ixazomib-based regimen treatment, RRMM patients who have received at least one dose non-IRd Ixazomib-based regimens treatment, and non-myeloma patients who have received at least one dose of Ixazomib-based regimens treatment. This study will be conducted in China. The overall time for the study will be approximately 57 months after the last site initiation. All patients will be followed-up for 21 months unless withdrawal of Informed Consent Form, lost or death, whichever comes first.

Study status

Ongoing
Research institutions and networks

Institutions

Depei Wu
The first affiliated hospital of Soochow University, Beijing Chaoyang hospital, Capital Medical University, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University China, West China Hospital, Sichuan University, Zhabei central hospital, jing 'an district, Sun Yat-sen University cancer center China, Henan Cancer Hospital, the Fourth Hospital of Hebei Medical University, Jinhua Municipal Central Hospital China, Tianjin Medical University General Hospital, Zhujiang Hospital of Southern Medical University, Beijing Chaoyang hospital, Capital Medical University (the West Hospital) China, Beijing Jishuitan Hospital, Peking University Third Hospital, The first affiliated hospital of Dalian Medical University China, The second hospital of Dalian Medical University, Harbin Medical University Cancer Hospital, The First Affiliated Hospital, Sun Yat-sen University China, Shandong Provincial Hospital, The First Hospital of Jilin University, Southern Medical University Nanfang Hospital China, Renji Hospital, Shanghai Jiaotong University, School of Medicine, Shanghai sixth people's hospital, Yijishan Hospital of Wannan Medical College China, Peking University First Hospital, The First affiliated hospital of Harbin Medical University, Harbin Institute of Hematology & Oncology, Harbin the First Hospital China, The third hospital of Hebei Medical University, Shanxi Cancer Hospital, Peking Union Medical College Hospital China

Contact details

Wu Depei

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Takeda
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable