Clinical trial NCT04328662: A Study of Ninlaro in Real World Clinical Practice in China
Official title: A National, Prospective, Non-interventional Study of NINLARO in Real World Clinical Practice
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Myeloma
Neoplasms, Plasma Cell
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2020-03-31
Enrollment: 482
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese participants with RRMM who have received at least one dose of IRd or non-IRd ixazomib based regimen treatment, and NDMM and non-myeloma who have received at least one dose of ixazomib-based regimen treatment will be observed prospectively.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants who Have one or More Adverse Events
timeFrame: From signing of the informed consent to 60 days after administration of the last dose of NINLARO (Up to Month 64)
Secondary outcomes:
measure: Number of Participants Reporting one or More Serious Adverse Events (SAEs), Adverse Drug Reaction (ADRs) and Adverse Events of Special Interest (AESI)
timeFrame: From signing of the informed consent to 60 days after administration of the last dose of NINLARO (Up to Month 64)
measure: Number of Participants With Dose Adjustments During the Study
timeFrame: Up to Month 64
measure: Number of Participants Categorized by Clinical Characteristics
timeFrame: Up to Month 64
measure: Number of Participants Based on Disease Characteristics
timeFrame: Up to Month 64
measure: Number of Participants With Multiple Myeloma Treatment
timeFrame: Up to Month 64
measure: Overall Survival (OS)
timeFrame: From the date of sign Informed Consent Form to the date of death due to any cause (Up to Month 64)
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Cancer Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Chao-yang Hospital,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chao-yang Hospital,Capital Medical University(Shijingshan)
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital, Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Suzhou
country: China
facility: Soochow Hongci Blood Disease Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical College
state: Shandong
city: Tai'an
country: China
facility: Tai'an Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Zhabei Central Hospital, Jing'an District, Shanghai
state: Shanghai
city: Datong
country: China
facility: Datong Third People's Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Shaoxing
country: China
facility: Shaoxing People's Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou First People's Hospital
state: Zhejiang
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: