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

Takeda

Status: Completed

Conditions: Multiple Myeloma

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT04840680

C16030

Details and patient eligibility

About

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.

Full 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.

Enrollment: 191 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

191 participants in 1 patient group

Participants With MM

Description:

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.

Treatment:

Other: No Intervention