A Study of NINLARO® in Chinese Adults With Multiple Myeloma

June 4, 2024 updated by: Takeda

Clinical Outcome of Ixazomib (NINLARO®) Based Regimens in Chinese Patients With Multiple Myeloma Previously Receiving a Bortezomib-Based Induction Regimen in Clinical Setting of Real World : An Open-Label, Single-Arm, Multicenter, Observation Study

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

Treatment with NINLARO® will strictly follow the product label.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a non-interventional, prospective study of participants with 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 320 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.

Study Type

Observational

Enrollment (Estimated)

320

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, 230000
        • Recruiting
        • Anhui Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Kaiyang Ding
    • Beijing
      • Beijing, Beijing, China, 100020
        • Recruiting
        • Beijing Chao-Yang Hospital,Capital Medical University
        • Contact:
        • Principal Investigator:
          • Wenming Chen
      • Beijing, Beijing, China, 100096
        • Recruiting
        • BeiJing JiShuiTan Hospital
        • Principal Investigator:
          • Li Bao
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450004
        • Recruiting
        • Henan Province People Hospital
        • Contact:
        • Principal Investigator:
          • Zhu Zunmin
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhenzhou University
        • Contact:
        • Principal Investigator:
          • Zhongxing Jiang
    • Inner Mongolia Autonomous Region
      • Hohhot, Inner Mongolia Autonomous Region, China, 010050
        • Recruiting
        • Affiliated Hospital of Inner Mongolia Medical University
        • Principal Investigator:
          • Da Gao
        • Contact:
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affiliated Hospital Of Soochow University
        • Contact:
        • Principal Investigator:
          • Chengcheng Fu
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Principal Investigator:
          • Fei Li
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110022
        • Recruiting
        • Shengjing Hospital Affiliated to China Medical University
        • Principal Investigator:
          • Wei Yang
        • Contact:
    • Qingdao
      • Qingdao, Qingdao, China, 266071
        • Recruiting
        • Qingdao Municipal Hospital
        • Contact:
        • Principal Investigator:
          • Yuping zhong
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • 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

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

Participants who have been first diagnosed with MM using IMWG criteria, and who have received a bortezomib-based triple-drug regimens (more than 2 cycles) as initial therapy, and must achieve at least PR as defined by IMWG criteria at the time of enrollment will be included in this study.

Description

Inclusion Criteria:

  1. Who first diagnosed with MM using IMWG 2016 criteria.

  2. Diagnosed with multiple myeloma using IMWG 2016 criteria and must be transplant ineligible as determined by their physician, or if transplant eligible, not expect to 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-based triple-drug regimens as frontline treatment, including bortezomib+cyclophosphamide+dexamethasone (VCD), bortezomib+lenalidomide dexamethasone (VRD), bortezomib+doxorubicin+dexamethasone (PAD), bortezomib+thalidomide+dexamethasone (VTD).
  4. Must achieve partial response (PR) as defined by IMWG 2016 criteria after bortezomib-based initial therapy.
  5. Eastern Cooperative Oncology Group (ECOG) 0-2.

Exclusion Criteria:

  1. Received a bortezomib-based triple-drug regimens as initial therapy less than 2 cycles.
  2. Failure to have fully recovered (that is, less than or equal to [<=] Grade 1 toxicity) from the reversible effects of prior chemotherapy.
  3. Have documented diagnosis of other cancers prior to the diagnosis of MM, excluding squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, 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 clinical examination at the time of enrollment.
  5. Previously been treated with ixazomib or participated in a study with ixazomib whether treated with ixazomib or not.
  6. Have gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing.
  7. Have an active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus positive.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants With Multiple Myeloma (MM)
Participants diagnosed with MM (Newly Diagnosed Multiple Myeloma [NDMM]) using IMWG criteria and received a bortezomib-based triple-drug regimens for more than 2 cycles as initial therapy will be treated with ixazomib based regimens strictly following NINLARO® label will be observed prospectively for 24 months.
Other: No intervention
This is a non-interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: From the date of first administration of ixazomib therapy to the date of first documentation of progressive disease (PD) or death, lost to follow-up, whichever occurs first (up to 24 months)
PFS: time date of first administration of ixazomib therapy to date of first documentation of PD/death, lost to follow-up, whichever occurs first assessed by IMWG 2016 Response Criteria. PD: increase of 25 percent(%) from lowest confirmed response value in any one/more of following: Serum and Urine M-protein only in participants without measurable serum and urine M-protein levels, difference between involved/uninvolved free light chain (FLC) levels (absolute increase greater than(>)10 milligram per deciliter [mg/dL]), and without measurable involved FLC levels, bone marrow plasma-cell% irrespective of baseline status (absolute increase must be >=10%); appearance of new lesions, >=50% increase from nadir in SPD of >1 lesion, or >=50% increase in the longest diameter of a previous lesion >1 centimeter in short axis; >=50% increase in circulating plasma cells (minimum of 200 cells per microliter [mcL]) if this is the only measure of disease. It will be analyzed using Kaplan-Meier method.
From the date of first administration of ixazomib therapy to the date of first documentation of progressive disease (PD) or death, lost to follow-up, whichever occurs first (up to 24 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Next Treatment (TTNT)
Time Frame: From the date of the first administration of ixazomib therapy to first dose of new treatment (up to 24 months)
Time to next treatment will be defined as the time from the date of the first administration of ixazomib therapy to first dose of new treatment given after changing the therapy.
From the date of the first administration of ixazomib therapy to first dose of new treatment (up to 24 months)
Percentage of Participants Achieving Very Good Partial Response (VGPR)
Time Frame: Up to 24 months
VGPR will be assessed as per International Myeloma Working Group (IMWG) 2016 Response Criteria, and defined as: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or greater than or equal to (>=) 90% reduction in serum M-protein plus urine M-protein level less than (<) 100 milligram (mg) per 24 hour (h).
Up to 24 months
Percentage of Participants Achieving Complete Response (CR)
Time Frame: Up to 24 months
CR will be assessed as per IMWG 2016 Response Criteria, and defined as: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates. For participants who only rely on serum FLC level as measurable lesions, in addition to meeting the above CR criteria, the ratio of serum FLC should return to normal under two consecutive assessments.
Up to 24 months
Percentage of Participants Achieving Stringent Complete Response (sCR)
Time Frame: Up to 24 months
sCR will be assessed as per IMWG 2016 Response Criteria, and defined as: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates. For participants who only rely on serum FLC level as measurable lesions, in addition to meeting the above CR criteria, the ratio of serum FLC should return to normal under two consecutive assessments. Absence of clonal plasma cells in bone marrow biopsy by immunohistochemistry. Presence of bone clonal plasma cells is defined as κ/λ >4:1 or <1:2 ratio under two consecutive detection by immunohistochemical method (for participants with type κ and type λ respectively, and requiring a minimum of 100 plasma cells for analysis).
Up to 24 months
Duration of Ixazomib Therapy (DOT)
Time Frame: Up to 24 months
DOT will be defined as the time from the date of the first administration of ixazomib triplet therapy to the date of the last administration of ixazomib therapy.
Up to 24 months
Duration of CR
Time Frame: Up to 24 months
Duration of CR will be defined as time from first documented CR to the date of PD as per IMWG 2016 Response Criteria.
Up to 24 months
Overall Survival (OS)
Time Frame: Up to 24 months
OS will be defined as the time from enrollment to death from any cause.
Up to 24 months
Health-related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC QLQ-MY20)
Time Frame: Up to 24 months
EORTC QLQ-MY20 is self-administered patient-reported outcomes (PRO) used to assess quality of life during the last 7 days. It has 20 items evaluated on 4 point rating scale ranging from: 1 (not at all), 2 (a little), 3 (quite a bit), 4 (very much). Total score ranges from 20 to 80. Higher scores represent worsening.
Up to 24 months
HRQOL Based on EORTC QLQ-C30
Time Frame: Up to 24 months
EORTC QLQ-C30 is self-administered PRO which contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/quality of life (QOL) scale. EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=Very poor [worst] to 7= Excellent [best]). Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QOL scale, higher scores represent better QOL; for the symptom scales, lower scores represent better QOL.
Up to 24 months
HRQOL Based on EuroQoL Group 5-Dimension 5-Level (EQ-5D-5L)
Time Frame: Up to 24 Months
The EQ-5D-5L is self-administered PRO. Its descriptive system assesses health in five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). This part of the EQ-5D questionnaire provides a descriptive profile that can be used to generate a health state profile. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale (VAS) on which the participant rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
Up to 24 Months
Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Time Frame: Up to 24 months
TSQM-9 is self-administered PRO. It is a 9-item, validated, self-administered instrument used to assess participant's satisfaction or dissatisfaction with medication. The three domains assessed are effectiveness, convenience, and global satisfaction. The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain.
Up to 24 months
Number of Participants Categorized Based on Healthcare Resource Utilization
Time Frame: Up to 24 months
Healthcare resource utilization will include outpatient visits to the study site, overnight hospital admissions, emergency department visits, and hospice care.
Up to 24 months
Number of Participants Categorized Based on Reason for Dose Reduction of Ixazomib Therapy
Time Frame: Up to 24 months
Up to 24 months
Number of Participants Categorized Based on Reason for Interruption of Ixazomib Therapy
Time Frame: Up to 24 months
Up to 24 months
Number of Participants Categorized Based on Reason for Discontinuation of Ixazomib Therapy
Time Frame: Up to 24 months
Up to 24 months
Relative Dose Intensity (RDI)
Time Frame: Up to 24 months
RDI is defined as 100*(Total amount of dose taken)/(Total prescribed dose of treated cycles), where total prescribed dose equals (dose prescribed at enrollment* number of prescribed doses per cycle* the number of treated cycles).
Up to 24 months
Number of Participants who Experience at Least one Adverse Event (AE)
Time Frame: Up to 24 months
Up to 24 months
Number of Participants Categorized Based on Occurrence of Second Primary Malignancies (SPM)
Time Frame: Up to 24 months
Up to 24 months

Collaborators and Investigators

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

Sponsor

Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

October 29, 2021

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

August 18, 2021

First Submitted That Met QC Criteria

August 18, 2021

First Posted (Actual)

August 19, 2021

Study Record Updates

Last Update Posted (Actual)

June 5, 2024

Last Update Submitted That Met QC Criteria

June 4, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C15058

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

Yes

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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