A Study of Real-World Use of Ixazomib Citrate in People With Multiple Myeloma (MM)
Post-Marketing Surveillance (Usage Results Study) of Ixazomib Citrate in Patients With Multiple Myeloma in South Korea
1 other identifier
observational
191
1 country
20
Brief Summary
In this study, people with MM will be treated with ixazomib citrate according to their clinic's standard practice. The main aim of the study is to check for side effects from ixazomib citrate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2021
Typical duration for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 22, 2021
CompletedFirst Submitted
Initial submission to the registry
April 9, 2021
CompletedFirst Posted
Study publicly available on registry
April 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2023
CompletedJuly 24, 2024
July 1, 2024
2.3 years
April 9, 2021
July 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Up to 6 months
Secondary Outcomes (2)
Progression-free Survival (PFS)
From first administration of study drug to the date of disease progression or death due to any cause, whichever occurs first (up to 6 months)
Overall Response Rate (ORR)
Up to 6 months
Study Arms (1)
Participants With MM
Participants with MM who are newly prescribed and will start treatment with ixazomib citrate in a real-world clinical practice setting will be observed prospectively for up to 6 years 11 months.
Interventions
Eligibility Criteria
Participants with MM who have been newly prescribed with ixazomib citrate in routine clinical practical setting will be observed prospectively.
You may qualify if:
- Participants with MM.
- Participants who are prescribed and initiate ixazomib citrate for the treatment of MM according to the ixazomib citrate South Korean product label.
You may not qualify if:
- Participants treated with ixazomib citrate outside of the locally approved label in South Korea.
- Participants for which ixazomib citrate is contraindicated as per product label.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (20)
Hallym University Sacred Heart Hospital
Anyang, 14068, South Korea
SOONCHUNHYANG UNIVERSITY HOSPITAL Bucheon
Bucheon-si, 14584, South Korea
Inje University Busan Paik Hospital
Busan, 47392, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Kosin University Gospel Hospital
Busan, 49267, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
Chungnam National Unversity Hospital
Daejeon, 35015, South Korea
Chonnam National University Hwasun Hospital
Hwasun, 58128, South Korea
The Catholic University of Korea, Incheon ST. Marys Hospital
Incheon, 21431, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Samsung medical center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul ST. Mary's Hospital
Seoul, 06591, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
Ewha womans university medical center
Seoul, 07985, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 26426, South Korea
Yongin Severance Hospital
Yŏngin, 16995, South Korea
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
April 9, 2021
First Posted
April 12, 2021
Study Start
March 22, 2021
Primary Completion
July 6, 2023
Study Completion
August 28, 2023
Last Updated
July 24, 2024
Record last verified: 2024-07
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.