A Study of Ninlaro in Real World Clinical Practice in China

Takeda482 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

482

Conditions

Multiple Myeloma Neoplasms, Plasma Cell

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Undergoing treatment with Ninlaro (of less than 3 months from initial treatment with Ninlaro) or to be prescribed with Ninlaro capsule. 2. Participants will be able to sign Informed Consent Form to participate. Exclusion Criteria: 1. Currently participates or plans to participate in any interventional clinical trial. 2. Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.

Locations (28)

Outcomes

Primary Outcomes

Number of Participants who Have one or More Adverse Events

Time frame: From signing of the informed consent to 60 days after administration of the last dose of NINLARO (Up to Month 64)

Secondary Outcomes

Number of Participants Reporting one or More Serious Adverse Events (SAEs), Adverse Drug Reaction (ADRs) and Adverse Events of Special Interest (AESI)

Time frame: From signing of the informed consent to 60 days after administration of the last dose of NINLARO (Up to Month 64)

Number of Participants With Dose Adjustments During the Study

Time frame: Up to Month 64

Number of Participants Categorized by Clinical Characteristics

Time frame: Up to Month 64

Number of Participants Based on Disease Characteristics

Time frame: Up to Month 64

Number of Participants With Multiple Myeloma Treatment

Time frame: Up to Month 64

Overall Survival (OS)

OS is measured as the time from the date of sign Informed Consent Form to the date of death due to any cause.

Time frame: From the date of sign Informed Consent Form to the date of death due to any cause (Up to Month 64)

Data from ClinicalTrials.gov

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Anhui Cancer Hospital

Hefei, Anhui, China

Beijing Chao-yang Hospital,Capital Medical University