A Study of Ninlaro in Real World Clinical Practice in China

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04328662
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Takeda
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Study Director
Principal Investigator Affiliation Takeda
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma, Neoplasms, Plasma Cell
Additional Details

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.

Arms & Interventions

Arms

: Cohort 1: Participants with RRMM

Participants diagnosed with relapsed or refractory multiple myeloma (RRMM) who have received at least one dose of ixazomib plus lenalidomide - low dose dexamethasone (IRd) treatment, will be observed prospectively. Data will be collected from study sites such as clinical departments and pharmacies in hospitals as a part of routine clinical visits of participants to evaluate effectiveness and safety information.

: Cohort 2: Participants with NDMM, RRMM, and Non-myeloma

Participants diagnosed with NDMM who have received at least one dose of ixazomib-based regimen treatment, diagnosed with RRMM who have received at least one dose non-IRd ixazomib-based regimens treatment, and diagnosed with non-myeloma who have received at least one dose of ixazomib-based regimens treatment, will be observed prospectively. Data will be collected from study sites such as clinical departments and pharmacies in hospitals as a part of routine clinical visits of participants to evaluate effectiveness and safety information.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Anhui Cancer Hospital, Hefei, Anhui, China

Status

Recruiting

Address

Anhui Cancer Hospital

Hefei, Anhui, 230031

Site Contact

Site Contact

dingkaiy@126.com

13966672170

Beijing, Beijing, China

Status

Recruiting

Address

Beijing Chao-yang Hospital,Capital Medical University

Beijing, Beijing, 100020

Site Contact

Site Contact

13910107759@163.com

13910107759

Peking University First Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Peking University First Hospital

Beijing, Beijing, 100034

Site Contact

Site Contact

dongy@hsc.pku.edu.cn

18210264969

Beijing Jishuitan Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Beijing Jishuitan Hospital

Beijing, Beijing, 100035

Site Contact

Site Contact

Baoliq909@sina.com

13810837430

Beijing, Beijing, China

Status

Recruiting

Address

Beijing Chao-yang Hospital,Capital Medical University(Shijingshan)

Beijing, Beijing, 100043

Site Contact

Site Contact

13366395016@163.com

13366395016

Peking University Third Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Peking University Third Hospital

Beijing, Beijing, 100191

Site Contact

Site Contact

Hongmei_jing@163.com

13661112910

Peking Union Medical College Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Peking Union Medical College Hospital

Beijing, Beijing, 100730

Sun Yat-Sen Memorial Hospital, Guangzhou, Guangdong, China

Status

Recruiting

Address

Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, 510120

Site Contact

Site Contact

Wxj6209@163.com

18922182890

Guangzhou, Guangdong, China

Status

Recruiting

Address

Zhujiang Hospital, Southern Medical University

Guangzhou, Guangdong, 510280

Site Contact

Site Contact

liyuhua2011gz@163.com

13533706656

Guangzhou, Guangdong, China

Status

Recruiting

Address

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630

Site Contact

Site Contact

jiajun.l@163.com

13826470223

Hainan General Hospital, Haikou, Hainan, China

Status

Recruiting

Address

Hainan General Hospital

Haikou, Hainan, 570311

Site Contact

Site Contact

linlier268@163.com

13976595976

Harbin, Heilongjiang, China

Status

Recruiting

Address

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081

Site Contact

Site Contact

aichun2002@Hotmail.com

13633611958

Henan Cancer Hospital, Zhengzhou, Henan, China

Status

Recruiting

Address

Henan Cancer Hospital

Zhengzhou, Henan, 450003

Site Contact

Site Contact

fdation@126.com

13526607830

Suzhou, Jiangsu, China

Status

Recruiting

Address

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006

Site Contact

Site Contact

drwudepei@163.com

13951102021

Soochow Hongci Blood Disease Hospital, Suzhou, Jiangsu, China

Status

Recruiting

Address

Soochow Hongci Blood Disease Hospital

Suzhou, Jiangsu, 215100

Site Contact

Site Contact

Jin088@sina.com

13812633202

Wuxi People's Hospital, Wuxi, Jiangsu, China

Status

Recruiting

Address

Wuxi People's Hospital

Wuxi, Jiangsu, 214023

Site Contact

Site Contact

ZX89232@126.com

13358111962

Changchun, Jilin, China

Status

Recruiting

Address

The First Bethune Hospital of Jilin University

Changchun, Jilin, 130021

Site Contact

Site Contact

sujung1963@163.com

15843073208

Dalian, Liaoning, China

Status

Recruiting

Address

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011

Site Contact

Site Contact

sunxl10411@163.com

18098875696

Shenyang, Liaoning, China

Status

Recruiting

Address

The First Hospital of China Medical University

Shenyang, Liaoning, 110001

Site Contact

Site Contact

liyanxy1@163.com

13998898232

Jining, Shandong, China

Status

Recruiting

Address

Affiliated Hospital of Jining Medical College

Jining, Shandong, 272007

Site Contact

Site Contact

gx-zhanghao@126.com

18678766569

Tai'an Central Hospital, Tai'an, Shandong, China

Status

Recruiting

Address

Tai'an Central Hospital

Tai'an, Shandong, 271099

Site Contact

Site Contact

bgcbgc1@163.com

18653819776

Shanghai, Shanghai, China

Status

Recruiting

Address

Zhabei Central Hospital, Jing'an District, Shanghai

Shanghai, Shanghai, 200070

Site Contact

Site Contact

zfsh257@163.com

18917632257

Datong Third People's Hospital, Datong, Shanxi, China

Status

Recruiting

Address

Datong Third People's Hospital

Datong, Shanxi, 037046

Site Contact

Site Contact

3442187166@qq.com

13703527731

Shanxi Provincial People's Hospital, Taiyuan, Shanxi, China

Status

Recruiting

Address

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, 030012

Site Contact

Site Contact

Jin0809@126.com

13623470080

West China Hospital, Sichuan University, Chengdu, Sichuan, China

Status

Recruiting

Address

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041

Site Contact

Site Contact

tingniu@sina.com

18980601242

Tianjin, Tianjin, China

Status

Recruiting

Address

Tianjin Medical University General Hospital

Tianjin, Tianjin, 300052

Site Contact

Site Contact

florai@sina.com

13920350233

Shaoxing People's Hospital, Shaoxing, Zhejiang, China

Status

Recruiting

Address

Shaoxing People's Hospital

Shaoxing, Zhejiang, 312099

Site Contact

Site Contact

fujiaping1@sina.com

13867529690

Taizhou First People's Hospital, Taizhou, Zhejiang, China

Status

Recruiting

Address

Taizhou First People's Hospital

Taizhou, Zhejiang, 318020

Site Contact

Site Contact

tyylily@aliyun.com

15105868468