NCT04328662

A Study of Ninlaro in Real World Clinical Practice in China

A National, Prospective, Non-interventional Study of NINLARO in Real World Clinical Practice

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 482 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to collect additional safety information of ixazomib citrate (Ninlaro) when used to treat multiple myeloma in real world clinical practice in China. Participants will be treated with Ninlaro according to the normal clinical practice during this study.

Detailed description

This is a prospective, non-interventional study in Chinese participants with relapsed refractory multiple myeloma (RRMM), newly diagnosed multiple myeloma (NDMM) and non-myeloma who are undergoing or will receive at least one dose of ixazomib citrate. Data will be collected to assess safety information when NINLARO is used in the real world, based on known risks and missing safety information. The study will enroll approximately 3000 patients. The data will be collected prospectively as part of routine clinical visits of participants. Participants will be assigned to one of the two observational cohorts: * Cohort 1: Participants with RRMM * Cohort 2: Participants with NDMM, RRMM, and Non-myeloma The multi-center trial will be conducted in China. The overall duration of study will be approximately 64 months. All participants will be followed up for 21 months unless withdrawal of Informed Consent Form, loss of follow-up or death, whichever comes first.

Conditions

• Multiple Myeloma
• Neoplasms, Plasma Cell

Timeline

• Start date: 2020-05-18
• Primary completion: 2026-02-13
• Completion: 2026-02-13
• First posted: 2020-03-31
• Last updated: 2026-03-04

Locations

28 sites across 1 country: China