A Study of Ninlaro in Real World Clinical Practice in China
A National, Prospective, Non-interventional Study of NINLARO in Real World Clinical Practice
3 other identifiers
observational
482
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Longer than P75 for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2020
CompletedFirst Posted
Study publicly available on registry
March 31, 2020
CompletedStudy Start
First participant enrolled
May 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2026
CompletedMarch 4, 2026
March 1, 2026
5.7 years
March 27, 2020
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants who Have one or More Adverse Events
From signing of the informed consent to 60 days after administration of the last dose of NINLARO (Up to Month 64)
Secondary Outcomes (6)
Number of Participants Reporting one or More Serious Adverse Events (SAEs), Adverse Drug Reaction (ADRs) and Adverse Events of Special Interest (AESI)
From signing of the informed consent to 60 days after administration of the last dose of NINLARO (Up to Month 64)
Number of Participants With Dose Adjustments During the Study
Up to Month 64
Number of Participants Categorized by Clinical Characteristics
Up to Month 64
Number of Participants Based on Disease Characteristics
Up to Month 64
Number of Participants With Multiple Myeloma Treatment
Up to Month 64
- +1 more secondary outcomes
Study Arms (2)
Cohort 1: Participants with RRMM
Participants diagnosed with relapsed or refractory multiple myeloma (RRMM) who have received at least one dose of ixazomib plus lenalidomide - low dose dexamethasone (IRd) treatment, will be observed prospectively. Data will be collected from study sites such as clinical departments and pharmacies in hospitals as a part of routine clinical visits of participants to evaluate effectiveness and safety information.
Cohort 2: Participants with NDMM, RRMM, and Non-myeloma
Participants diagnosed with NDMM who have received at least one dose of ixazomib-based regimen treatment, diagnosed with RRMM who have received at least one dose non-IRd ixazomib-based regimens treatment, and diagnosed with non-myeloma who have received at least one dose of ixazomib-based regimens treatment, will be observed prospectively. Data will be collected from study sites such as clinical departments and pharmacies in hospitals as a part of routine clinical visits of participants to evaluate effectiveness and safety information.
Eligibility Criteria
Chinese participants with RRMM who have received at least one dose of IRd or non-IRd ixazomib based regimen treatment, and NDMM and non-myeloma who have received at least one dose of ixazomib-based regimen treatment will be observed prospectively.
You may qualify if:
- Undergoing treatment with Ninlaro (of less than 3 months from initial treatment with Ninlaro) or to be prescribed with Ninlaro capsule.
- Participants will be able to sign Informed Consent Form to participate.
You may not qualify if:
- Currently participates or plans to participate in any interventional clinical trial.
- Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (28)
Anhui Cancer Hospital
Hefei, Anhui, 230031, China
Beijing Chao-yang Hospital,Capital Medical University
Beijing, Beijing Municipality, 100020, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, 100035, China
Beijing Chao-yang Hospital,Capital Medical University(Shijingshan)
Beijing, Beijing Municipality, 100043, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, 510120, China
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, 510280, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
Hainan General Hospital
Haikou, Hainan, 570311, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Soochow Hongci Blood Disease Hospital
Suzhou, Jiangsu, 215100, China
Wuxi People's Hospital
Wuxi, Jiangsu, 214023, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Affiliated Hospital of Jining Medical College
Jining, Shandong, 272007, China
Tai'an Central Hospital
Tai’an, Shandong, 271099, China
Zhabei Central Hospital, Jing'an District, Shanghai
Shanghai, Shanghai Municipality, 200070, China
Datong Third People's Hospital
Datong, Shanxi, 037046, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, 030012, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Shaoxing People's Hospital
Shaoxing, Zhejiang, 312099, China
Taizhou First People's Hospital
Taizhou, Zhejiang, 318020, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2020
First Posted
March 31, 2020
Study Start
May 18, 2020
Primary Completion
February 13, 2026
Study Completion
February 13, 2026
Last Updated
March 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.