Clinical trial NCT04840680: A Study of Real-World Use of Ixazomib Citrate in People With Multiple Myeloma (MM)
Official title: Post-Marketing Surveillance (Usage Results Study) of Ixazomib Citrate in Patients With Multiple Myeloma in South Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-04-12
Enrollment: 191
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with MM who have been newly prescribed with ixazomib citrate in routine clinical practical setting will be observed prospectively.

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 6 months
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: 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)
measure: Overall Response Rate (ORR)
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Bucheon
country: Korea, Republic of
facility: SOONCHUNHYANG UNIVERSITY HOSPITAL Bucheon
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National Unversity Hospital
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon ST. Marys Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul ST. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha womans university medical center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Wonju
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Yongin
country: Korea, Republic of
facility: Yongin Severance Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: