A Study of Ninlaro in Real World Clinical Practice in China

Active, not recruiting

• Conditions: Multiple Myeloma; Neoplasms, Plasma Cell

• Registration Number: NCT04328662
• Lead Sponsor: Takeda

Brief 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.

Study Timeline

• Study First Submitted: 2020-03-27
• Study First Submitted QC: 2020-03-27
• Study First Posted: 2020-03-31
• Study Start: 2020-05-18
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 482

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants who Have one or More Adverse Events	From signing of the informed consent to 60 days after administration of the last dose of NINLARO (Up to Month 64)

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Dose Adjustments During the Study	Up to Month 64
Number of Participants Based on Disease Characteristics	Up to Month 64
Number of Participants Reporting one or More Serious Adverse Events (SAEs), Adverse Drug Reaction (ADRs) and Adverse Events of Special Interest (AESI)	From signing of the informed consent to 60 days after administration of the last dose of NINLARO (Up to Month 64)
Number of Participants Categorized by Clinical Characteristics	Up to Month 64
Number of Participants With Multiple Myeloma Treatment	Up to Month 64
Overall Survival (OS)	From the date of sign Informed Consent Form to the date of death due to any cause (Up to Month 64)	OS is measured as the time from the date of sign Informed Consent Form to the date of death due to any cause.

Trial Locations

Locations (28)

Beijing Chao-yang Hospital,Capital Medical University(Shijingshan); 🇨🇳 Beijing, Beijing, China

Anhui Cancer Hospital; 🇨🇳 Hefei, Anhui, China

Beijing Chao-yang Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Jishuitan Hospital; 🇨🇳 Beijing, Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Zhujiang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

The Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Hainan General Hospital; 🇨🇳 Haikou, Hainan, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, Heilongjiang, China

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China

Soochow Hongci Blood Disease Hospital; 🇨🇳 Suzhou, Jiangsu, China

Wuxi People's Hospital; 🇨🇳 Wuxi, Jiangsu, China

The First Bethune Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

The First Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, Liaoning, China

The First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

Affiliated Hospital of Jining Medical College; 🇨🇳 Jining, Shandong, China

Zhabei Central Hospital, Jing'an District, Shanghai; 🇨🇳 Shanghai, Shanghai, China

Datong Third People's Hospital; 🇨🇳 Datong, Shanxi, China

Shanxi Provincial People's Hospital; 🇨🇳 Taiyuan, Shanxi, China

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Shaoxing People's Hospital; 🇨🇳 Shaoxing, Zhejiang, China

Taizhou First People's Hospital; 🇨🇳 Taizhou, Zhejiang, China

Sun Yat-Sen Memorial Hospital; 🇨🇳 Guangzhou, Guangdong, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Tai'an Central Hospital; 🇨🇳 Tai'an, Shandong, China

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China