NCT04840680

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 191 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
OTHER	No Intervention	This is a non-interventional study.

Timeline

• Start date: 2021-03-22
• Primary completion: 2023-07-06
• Completion: 2023-08-28
• First posted: 2021-04-12
• Last updated: 2024-07-24

Locations

20 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study