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NCT04840680 Clinical Trial

A Study of Real-World Use of Ixazomib Citrate in People With Multiple Myeloma (MM)

Multiple Myeloma Clinical Trial

Official title:
Post-Marketing Surveillance (Usage Results Study) of Ixazomib Citrate in Patients With Multiple Myeloma in South Korea

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04840680
Other study ID # C16030
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 22, 2021
Est. completion date June 27, 2024

Study information
Verified date May 2023
Source Takeda
Contact Takeda Contact
Phone +1-877-825-3327
Email medinfoUS@takeda.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

This is a non-interventional, prospective, observational post-marketing surveillance study of ixazomib citrate in participants with MM. The study will assess the safety and effectiveness of ixazomib citrate for its approved indications in a clinical practice setting under real-world conditions. The study will enroll approximately 165 participants. The data will be prospectively collected, at the centers from medical files and recorded into electronic case report forms (e-CRFs). All participants will be enrolled in a single observational group: • Participants With MM The study will be conducted in South Korea. The overall duration of the study will be approximately 6 years and 11 months. Data will be collected over and up to a 6 months-surveillance period (per participant) once enrolled.

Recruitment information / eligibility
Status Recruiting
Enrollment 165
Est. completion date June 27, 2024
Est. primary completion date June 27, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Participants with MM. 2. Participants who are prescribed and initiate ixazomib citrate for the treatment of MM according to the ixazomib citrate South Korean product label. Exclusion Criteria: 1. Participants treated with ixazomib citrate outside of the locally approved label in South Korea. 2. Participants for which ixazomib citrate is contraindicated as per product label.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No Intervention
This is a non-interventional study.

Locations
Country Name City State
Korea, Republic of Hallym University Sacred Heart Hospital Anyang
Korea, Republic of SOONCHUNHYANG UNIVERSITY HOSPITAL Bucheon Bucheon
Korea, Republic of Inje University Busan Paik Hospital Busan
Korea, Republic of Kosin University Gospel Hospital Busan
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of Keimyung University Dongsan Hospital Daegu
Korea, Republic of Kyungpook National University Hospital Daegu
Korea, Republic of Chungnam National Unversity Hospital Daejeon
Korea, Republic of Chonnam National University Hwasun Hospital Hwasun
Korea, Republic of The Catholic University of Korea, Incheon ST. Marys Hospital Incheon
Korea, Republic of Chung-Ang University Hospital Seoul
Korea, Republic of Ewha womans university medical center Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Samsung medical center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of The Catholic University of Korea Seoul ST. Mary's Hospital Seoul
Korea, Republic of Ajou University Hospital Suwon
Korea, Republic of Yonsei University Wonju Severance Christian Hospital Wonju
Korea, Republic of Yongin Severance Hospital Yongin

Sponsors (1)
Lead Sponsor Collaborator
Takeda

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Up to 6 months
Secondary Progression-free Survival (PFS) PFS is defined as the estimated length of time since the start of treatment with ixazomib to disease progression (PD), study end or death, whichever occurs first. PFS will be assessed by International Myeloma Working Group (IMWG) Criteria, PD: increase of greater than or equal to (>=) 25 percent (%) from lowest response value in any one or more of the following: serum M-component increase >=0.5 gram per deciliter (g/dL) or urine M-component increase >=200 milligram (mg)/24-hour; difference between involved and uninvolved free light chains (FLC) levels increase must be greater than (>) 10 mg/dL; bone marrow plasma cell >=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder. PFS will be analyzed using Kaplan-Meier method. 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)
Secondary Overall Response Rate (ORR) ORR is defined as the percentage of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) based on the review of the myeloma response data assessed by IMWG criteria. sCR: CR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; CR: negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (<) 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein level <100 mg/24 hour; PR: >=50% reduction of serum M-protein and >=90% reduction in urine M-protein or <200 mg/24 hour, or >=50% decrease in uninvolved FLC or >=50% reduction in plasma cells. At baseline, a >=50% decrease in size of soft tissue plasmacytomas is required. Up to 6 months
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