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Ninlaro Intensive Drug Monitoring Protocol

Sponsor
Takeda (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04328662
Collaborator
(none)
3,000
Enrollment
28
Locations
53.5
Anticipated Duration (Months)
107.1
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the safety profile of ixazomib citrate (Ninlaro) to fulfill the regulatory authority's requirement of intensive drug monitoring (IDM) in Chinese population.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a prospective, non-interventional study in Chinese participants with RRMM, 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 used in the real world, based on known risks and missing safety information.

    The study will enroll approximately 3000 participants. 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 57 months. All participants will be followed up for 21 months unless withdrawal of Informed Consent Form, lost or death, whichever comes first.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A National, Prospective, Non-interventional Study of NINLARO in Real World Clinical Practice
    Actual Study Start Date :
    May 18, 2020
    Anticipated Primary Completion Date :
    Oct 31, 2024
    Anticipated Study Completion Date :
    Oct 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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 with NDMM, RRMM, and Non-myeloma Participants diagnosed with newly diagnosed multiple myeloma (NDMM) who have received at least one dose of ixazomib-based regimen treatment and 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.

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants who Have one or More Adverse Events [Up to Month 57]

    Secondary Outcome Measures

    1. Number of Participants Reporting one or More Serious Adverse Events (SAEs), Adverse Drug Reaction (ADRs) and Adverse Events of Special Interest (AESI) [Up to Month 57]

    2. Number of Participants With Dose Adjustments During the Study [Up to Month 57]

    3. Number of Participants Categorized by Clinical Characteristics [Up to Month 57]

    4. Number of Participants Based on Disease Characteristics [Up to Month 57]

    5. Number of Participants With Multiple Myeloma Treatment [Up to Month 57]

    6. Overall Survival (OS) [From the date of sign Informed Consent Form to the date of death due to any cause (up to Month 57)]

      OS is measured as the time from the date of sign Informed Consent Form to the date of death due to any cause.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

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

    Exclusion Criteria:
    1. Currently participates or plans to participate in any interventional clinical trial.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anhui Cancer Hospital Hefei Anhui China 230031
    2 Beijing Chao-yang Hospital,Capital Medical University Beijing Beijing China 100020
    3 Peking University First Hospital Beijing Beijing China 100034
    4 Beijing Jishuitan Hospital Beijing Beijing China 100035
    5 Beijing Chao-yang Hospital,Capital Medical University(Shijingshan) Beijing Beijing China 100043
    6 Peking University Third Hospital Beijing Beijing China 100191
    7 Peking Union Medical College Hospital Beijing Beijing China 100730
    8 Zhujiang Hospital, Southern Medical University Guangzhou Guangdong China 510280
    9 The Third Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong China 510630
    10 Hainan General Hospital Haikou Hainan China 570311
    11 Harbin Medical University Cancer Hospital Harbin Heilongjiang China 150081
    12 Henan Cancer Hospital Zhengzhou Henan China 450003
    13 The First Affiliated Hospital of Soochow University Suzhou Jiangsu China 215006
    14 Soochow Hongci Blood Disease Hospital Suzhou Jiangsu China 215100
    15 Wuxi People's Hospital Wuxi Jiangsu China 214023
    16 The First Bethune Hospitl of Jilin University Changchun Jilin China 130021
    17 The First Affiliated Hospital of Dalian Medical University Dalian Liaoning China 116011
    18 The First Hospital of China Medical University Shenyang Liaoning China 110001
    19 Affiliated Hospital of Jining Medical College Jining Shandong China 272007
    20 Tai'an Central Hospital Tai'an Shandong China 271099
    21 Zhabei Central Hospital, Jing'an District, Shanghai Shanghai Shanghai China 200070
    22 Shanxi Provincial People's Hospital Shanghai Shanghai China 30012
    23 Datong Third People's Hospital Datong Shanxi China 037046
    24 Shanxi Provincial People's Hospital Taiyuan Shanxi China 030012
    25 West China Hospital, Sichuan University Chengdu Sichuan China 610041
    26 Tianjin Medical University General Hospital Tianjin Tianjin China 300052
    27 Shaoxing People's Hospital Shaoxing Zhejiang China 312099
    28 Taizhou First People's Hospital Taizhou Zhejiang China 318020

    Sponsors and Collaborators

    • Takeda

    Investigators

    • Study Director: Medical Director, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Takeda
    ClinicalTrials.gov Identifier:
    NCT04328662
    Other Study ID Numbers:
    • C16050
    • U1111-1237-5126
    • EUPAS30733
    First Posted:
    Mar 31, 2020
    Last Update Posted:
    Feb 25, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Takeda
    Drug Therapy
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell

    Study Results

    No Results Posted as of Feb 25, 2022