A Study of Ninlaro in Real World Clinical Practice in China

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04328662
• Other study ID #: C16050
• Secondary ID: U1111-1237-5126E
• Status: Recruiting
• Start date: May 18, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: November 2023
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Locations

Country	Name	City	State
China	Beijing Chao-yang Hospital,Capital Medical University	Beijing	Beijing
China	Beijing Chao-yang Hospital,Capital Medical University(Shijingshan)	Beijing	Beijing
China	Beijing Jishuitan Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The First Bethune Hospital of Jilin University	Changchun	Jilin
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	Datong Third People's Hospital	Datong	Shanxi
China	Sun Yat-Sen Memorial Hospital	Guangzhou	Guangdong
China	The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	Zhujiang Hospital, Southern Medical University	Guangzhou	Guangdong
China	Hainan General Hospital	Haikou	Hainan
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Anhui Cancer Hospital	Hefei	Anhui
China	Affiliated Hospital of Jining Medical College	Jining	Shandong
China	Zhabei Central Hospital, Jing'an District, Shanghai	Shanghai	Shanghai
China	Shaoxing People's Hospital	Shaoxing	Zhejiang
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Soochow Hongci Blood Disease Hospital	Suzhou	Jiangsu
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Tai'an Central Hospital	Tai'an	Shandong
China	Shanxi Provincial People's Hospital	Taiyuan	Shanxi
China	Taizhou First People's Hospital	Taizhou	Zhejiang
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Number of Participants With Dose Adjustments During the Study		Up to Month 64
Secondary	Number of Participants Categorized by Clinical Characteristics		Up to Month 64
Secondary	Number of Participants Based on Disease Characteristics		Up to Month 64
Secondary	Number of Participants With Multiple Myeloma Treatment		Up to Month 64
Secondary	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.	From the date of sign Informed Consent Form to the date of death due to any cause (Up to Month 64)