A Study of NINLARO® in Chinese Adults With Multiple Myeloma

Last updated: September 24, 2024
Sponsor: Takeda
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Myeloma

Cancer/tumors

Lymphoproliferative Disorders

Treatment

No intervention

Clinical Study ID

NCT05013190
C15058
  • Ages > 18
  • All Genders

Study Summary

The main aim of this study is to check side effects and results in adults with multiple myeloma after switching from a bortezomib/carfilzomib -based to an Ixazomib-based treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Who was first diagnosed or first relapse MM participants using IMWG 2016 criteria.

  2. Diagnosed with multiple myeloma using IMWG 2016 criteria and must be transplantineligible as determined by their physician, or if transplant eligible, not expectto undergo transplant for at least 24 months after study enrollment. o Stem cell harvest and mobilization regimen is acceptable if clinically indicated.But must first be confirmed by the Takeda Medical Monitor.

  3. Who received bortezomib/carfilzomib-based triple-drug regimens as frontlinetreatment, including bortezomib+cyclophosphamide+dexamethasone (VCD),bortezomib+lenalidomide dexamethasone (VRD), bortezomib+doxorubicin+dexamethasone (PAD), bortezomib+thalidomide+dexamethasone (VTD),bortezomib+pomadomide+dexamethasone (VPD), or carfilzomib+lenalidomide+dexamethasone (KRD), carfilzomib+thalidomide+dexamethasone (KTD),carfilzomib+pomalidomide+dexamethasone (KPD).

  4. Must achieve partial response (PR) as defined by IMWG 2016 criteria afterbortezomib/carfilzomib-based initial therapy.

  5. Eastern Cooperative Oncology Group (ECOG) 0-2.

Exclusion

Exclusion Criteria:

  1. Received a bortezomib/carfilzomib-based triple-drug regimens as initial therapy lessthan 2 cycles.

  2. Failure to have fully recovered (that is, less than or equal to [<=] Grade 1toxicity) from the reversible effects of prior chemotherapy.

  3. Have documented diagnosis of other cancers prior to the diagnosis of MM, excludingsquamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix orbreast, which is considered cured with minimal risk of recurrence within 3 years.

  4. Has >=Grade 2 peripheral neuropathy (PN), or Grade 1 with pain on clinicalexamination at the time of enrollment.

  5. Previously been treated with ixazomib or participated in a study with ixazomibwhether treated with ixazomib or not.

  6. Have gastrointestinal (GI) disease or GI procedure that could interfere with theoral absorption or tolerance of ixazomib including difficulty swallowing.

  7. Have an active systemic infection, active hepatitis B or C virus infection, or knownhuman immunodeficiency virus positive.

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: No intervention
Phase:
Study Start date:
October 29, 2021
Estimated Completion Date:
June 30, 2027

Study Description

This is a non-interventional, prospective study of participants with multiple myeloma (MM). Participants will be treated with ixazomib based regimens until progression or unacceptable toxicity leading to a discontinuation or change in regimen, for a maximum of 26 cycles (24 months) (as per NINLARO® label) in real world clinical setting.

The study will enroll approximately 160 participants. The data will be collected prospectively in medical charts and will be recorded into electronic case report forms (eCRFs). All the participants will be assigned to a single observational cohort:

• Participants with MM

This multi-center trial will be conducted in China. The overall time for data collection in the study will be 24 months. Participants will be followed once every 3 months unless withdraw of informed consent form, death or lost to follow-up, termination of the study by the sponsor, whichever comes first.

Connect with a study center

  • Anhui Cancer Hospital

    Hefei, Anhui 230000
    China

    Active - Recruiting

  • Hematology Department

    Hefei, Anhui 230000
    China

    Active - Recruiting

  • Beijing Chao-Yang Hospital,Capital Medical University

    Beijing, Beijing 100020
    China

    Active - Recruiting

  • Beijing Jishuitan Hospital

    Beijing, Beijing 100096
    China

    Active - Recruiting

  • Hematology Department

    Beijing, Beijing 100020
    China

    Active - Recruiting

  • Hematology Department

    Zhengzhou, Henan 450052
    China

    Active - Recruiting

  • Henan Province People Hospital

    Zhengzhou, Henan 450004
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhenzhou University

    Zhengzhou, Henan 450052
    China

    Active - Recruiting

  • Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia Autonomous Region 010050
    China

    Active - Recruiting

  • Hematology Department

    Hohhot, Inner Mongolia Autonomous Region 010050
    China

    Site Not Available

  • Hematology Department

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

  • Hematology Department

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • Hematology Department

    Shenyang, Liaoning 110022
    China

    Site Not Available

  • Shengjing Hospital affiliated to China Medical University

    Shenyang, Liaoning 110022
    China

    Active - Recruiting

  • Hematology Department

    Qingdao, Qingdao 266071
    China

    Active - Recruiting

  • Qingdao Municipal Hospital

    Qingdao, Qingdao 266071
    China

    Active - Recruiting

  • Hematology Department

    Chengdu, Sichuan 610000
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 610000
    China

    Active - Recruiting

  • Hematology Department

    Tianjin, Tianjin 300052
    China

    Active - Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin 300052
    China

    Active - Recruiting

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