A Study of Ninlaro in Real World Clinical Practice in China

November 22, 2023 updated by: Takeda

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230031
        • Recruiting
        • Anhui Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Kaiyang Ding
    • Beijing
      • Beijing, Beijing, China, 100730
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University first hospital
        • Principal Investigator:
          • Yujun Dong
        • Contact:
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
        • Principal Investigator:
          • Hongmei Jing
      • Beijing, Beijing, China, 100035
        • Recruiting
        • BeiJing JiShuiTan Hospital
        • Contact:
        • Principal Investigator:
          • Li Bao
      • Beijing, Beijing, China, 100020
        • Recruiting
        • Beijing Chao-Yang Hospital,Capital medical university
        • Contact:
        • Principal Investigator:
          • Wenming Chen
      • Beijing, Beijing, China, 100043
        • Recruiting
        • Beijing Chao-yang Hospital,Capital Medical University(Shijingshan)
        • Contact:
        • Principal Investigator:
          • Zhongxia Huang
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Sun Yat-sen Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Xiuju Wang
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • The Third Affiliated Hospital of Sun Yat-sen University
        • Contact:
        • Principal Investigator:
          • Jiajun Liu
      • Guangzhou, Guangdong, China, 510280
        • Recruiting
        • Zhujiang Hospital, Southern Medical University
        • Contact:
        • Principal Investigator:
          • Yuhua Li
    • Hainan
      • Haikou, Hainan, China, 570311
        • Recruiting
        • Hainan General Hospital
        • Principal Investigator:
          • Lie Lin
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Aichun Liu
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Baijun Fang
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
        • Principal Investigator:
          • Depei Wu
      • Suzhou, Jiangsu, China, 215100
        • Recruiting
        • Soochow Hongci Blood Disease Hospital
        • Contact:
        • Principal Investigator:
          • Song Jin
      • Wuxi, Jiangsu, China, 214023
        • Recruiting
        • Wuxi People's Hospital
        • Principal Investigator:
          • Xin zhou
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Bethune Hospital of Jilin University
        • Contact:
        • Principal Investigator:
          • Sujun Gao
    • Liaoning
      • Dalian, Liaoning, China, 116011
        • Recruiting
        • The First Affiliated Hospital of Dalian Medical University
        • Contact:
        • Principal Investigator:
          • Xiuli Sun
      • Shenyang, Liaoning, China, 110001
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:
        • Principal Investigator:
          • Yan Li
    • Shandong
      • Jining, Shandong, China, 272007
        • Recruiting
        • Affiliated Hospital of Jining Medical College
        • Principal Investigator:
          • Hao Zhang
        • Contact:
      • Tai'an, Shandong, China, 271099
        • Recruiting
        • Tai'an Central Hospital
        • Contact:
        • Principal Investigator:
          • Guanchen Bai
    • Shanghai
      • Shanghai, Shanghai, China, 200070
        • Recruiting
        • Zhabei Central Hospital, Jing'an District, Shanghai
        • Contact:
        • Principal Investigator:
          • Fan Zhou
    • Shanxi
      • Datong, Shanxi, China, 037046
        • Recruiting
        • Datong Third People's Hospital
        • Contact:
        • Principal Investigator:
          • Yaqing Feng
      • Taiyuan, Shanxi, China, 030012
        • Recruiting
        • Shanxi Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Jin Chang
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
        • Principal Investigator:
          • Ting Niu
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
        • Principal Investigator:
          • Rong Fu
    • Zhejiang
      • Shaoxing, Zhejiang, China, 312099
        • Recruiting
        • Shaoxing People's Hospital
        • Contact:
        • Principal Investigator:
          • Jiaping Fu
      • Taizhou, Zhejiang, China, 318020
        • Recruiting
        • Taizhou First People's Hospital
        • Contact:
        • Principal Investigator:
          • Lili Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Director: Study Director, Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2020

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

March 27, 2020

First Submitted That Met QC Criteria

March 27, 2020

First Posted (Actual)

March 31, 2020

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C16050
  • U1111-1237-5126 (Registry Identifier: WHO)
  • EUPAS30733 (Registry Identifier: ENCEPP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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