A Study of Ninlaro in Real World Clinical Practice in China

Last updated: April 9, 2025
Sponsor: Takeda
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Bone Neoplasm

Leukemia

Lymphoproliferative Disorders

Treatment

N/A

Clinical Study ID

NCT04328662
C16050
U1111-1237-5126
EUPAS30733
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Undergoing treatment with Ninlaro (of less than 3 months from initial treatment withNinlaro) or to be prescribed with Ninlaro capsule.

  2. Participants will be able to sign Informed Consent Form to participate.

Exclusion

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 participantunsuitable to participate in this study.

Study Design

Total Participants: 482
Study Start date:
May 18, 2020
Estimated Completion Date:
March 30, 2026

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.

Connect with a study center

  • Anhui Cancer Hospital

    Hefei, Anhui 230031
    China

    Site Not Available

  • Beijing Chao-yang Hospital,Capital Medical University

    Beijing, Beijing 100020
    China

    Site Not Available

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

    Beijing, Beijing 100043
    China

    Site Not Available

  • Beijing Jishuitan Hospital

    Beijing, Beijing 100035
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Site Not Available

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Site Not Available

  • Sun Yat-Sen Memorial Hospital

    Guangzhou, Guangdong 510120
    China

    Site Not Available

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong 510630
    China

    Site Not Available

  • Zhujiang Hospital, Southern Medical University

    Guangzhou, Guangdong 510280
    China

    Site Not Available

  • Hainan General Hospital

    Haikou, Hainan 570311
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150081
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • Soochow Hongci Blood Disease Hospital

    Suzhou, Jiangsu 215100
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • Wuxi People's Hospital

    Wuxi, Jiangsu 214023
    China

    Site Not Available

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • The First Bethune Hospitl of Jilin University

    Changchun, Jilin 130021
    China

    Active - Recruiting

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning 116011
    China

    Site Not Available

  • The First Hospital of China Medical University

    Shenyang, Liaoning 110001
    China

    Site Not Available

  • Affiliated Hospital of Jining Medical College

    Jining, Shandong 272007
    China

    Site Not Available

  • Tai'an Central Hospital

    Tai'an, Shandong 271099
    China

    Site Not Available

  • Shanxi Provincial People's Hospital

    Shanghai, Shanghai 30012
    China

    Active - Recruiting

  • Zhabei Central Hospital, Jing'an District, Shanghai

    Shanghai, Shanghai 200070
    China

    Site Not Available

  • Datong Third People's Hospital

    Datong, Shanxi 037046
    China

    Site Not Available

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi 030012
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • Shaoxing People's Hospital

    Shaoxing, Zhejiang 312099
    China

    Site Not Available

  • Taizhou First People's Hospital

    Taizhou, Zhejiang 318020
    China

    Site Not Available

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