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Multiple MyelomaNCT05013190

A Study of NINLARO® in Chinese Adults With Multiple Myeloma

An observational study of Multiple Myeloma, run by Takeda at 12 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
How many people
72 participants
Where
12 sitesChina
Study dates
29 Oct 2021to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants who have been first diagnosed with MM and FRMM using IMWG criteria, and who have received a bortezomib/carfilzomib-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.

Who may be able to join

  • Who was first diagnosed or first relapse MM participants using IMWG 2016 criteria.
  • 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.
  • Stem cell harvest and mobilization regimen is acceptable if clinically indicated. But must first be confirmed by the Takeda Medical Monitor.
  • Who received bortezomib/carfilzomib-based triple-drug regimens as frontline treatment, 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).
  • Must achieve at least partial response (PR) as defined by IMWG criteria after bortezomib/carfilzomib-based initial therapy.
  • Eastern Cooperative Oncology Group (ECOG) 0-2.

Who cannot join

  • Received a bortezomib/carfilzomib-based triple-drug regimens as initial therapy less than 2 cycles.
  • Failure to have fully recovered (that is, less than or equal to [<=] Grade 1 toxicity) from the reversible effects of prior chemotherapy.
  • 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.
  • Has >=Grade 2 peripheral neuropathy (PN), or Grade 1 with pain on clinical examination at the time of enrollment.
  • Previously been treated with ixazomib or participated in a study with ixazomib whether treated with ixazomib or not.
  • Have gastrointestinal (GI) disease or procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing.
  • Have an active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus positive.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • Beijing Chao-Yang Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100020

  • Beijing Jishuitan Hospital

    Beijing, Beijing Municipality, 100096

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610000

  • Anhui Cancer Hospital

    Hefei, Anhui, 230000

  • Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010050

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Qingdao Municipal Hospital

    Qingdao, Shandong, 266071

  • Shengjing Hospital affiliated to China Medical University

    Shenyang, Liaoning, 110022

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Henan Province People's Hospital

    Zhengzhou, Henan, 450004

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: Clinical Outcome of Ixazomib (NINLARO®) Based Regimens in Chinese Patients With Multiple Myeloma Previously Receiving a Bortezomib/Carfilzomib-Based (re)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/carfilzomib -based to an Ixazomib-based treatment.

Read the detailed 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 80 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 for a period not exceeding 24 months, ending 12 months after the last participant's enrollment unless withdraw of informed consent form, death or lost to follow-up, termination of the study by the sponsor, whichever comes first.

Being tested
No intervention
Keywords
Drug Therapy
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    This is a non-interventional study.

Study groups in NCT05013190
Study groupRoleWhat they receive
Participants With Multiple Myeloma (MM)Participants diagnosed with MM (newly diagnosed multiple myeloma [NDMM] and first relapse multiple myeloma [FRMM]) using International Myeloma Working Group (IMWG) criteria who received a bortezomib/carfilzomib-based triple-drug regimens for more than 2 cycles as initial therapy, achieved at least partial response (PR) as defined by IMWG criteria, and are ready to start receiving an ixazomib containing therapy prescribed by their treating physician will be observed prospectively for 24 months.
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) at 24 Months

    PFS:time date of first administration of ixazomib therapy to date of first documentation of progressive disease(PD)/death,lost to follow-up,whichever occurs first as per 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/ ≥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.

    Measured: From the date of first administration of ixazomib therapy to the date of first documentation of PD or death, lost to follow-up, whichever occurs first (up to 24 months)

Secondary outcomes (17)

  1. Time to Next Treatment (TTNT)

    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.

    Measured: From the date of the first administration of ixazomib therapy to first dose of new treatment (up to 24 months)

  2. Percentage of Participants Achieving Very Good Partial Response (VGPR)

    VGPR will be assessed as per 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).

    Measured: Up to 24 months

  3. Percentage of Participants Achieving Complete Response (CR)

    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.

    Measured: Up to 24 months

  4. Percentage of Participants Achieving Stringent Complete Response (sCR)

    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).

    Measured: Up to 24 months

  5. Duration of Ixazomib Therapy (DOT)

    DOT will be defined as the time from the date of the first administration of ixazomib therapy to the date of the last administration of ixazomib therapy.

    Measured: Up to 24 months

  6. Duration of CR

    Duration of CR will be defined as time from first documented CR to the date of PD as per IMWG 2016 Response Criteria.

    Measured: Up to 24 months

  7. Overall Survival (OS)

    OS will be defined as the time from enrollment to death from any cause.

    Measured: Up to 24 months

  8. Health-related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC QLQ-MY20)

    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.

    Measured: Up to 24 months

  9. HRQOL Based on EORTC QLQ-C30

    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.

    Measured: Up to 24 months

  10. Treatment Satisfaction Questionnaire for Medication (TSQM-9)

    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.

    Measured: Up to 24 months

  11. Number of Participants Categorized Based on Healthcare Resource Utilization

    Healthcare resource utilization will include outpatient visits to the study site, overnight hospital admissions, emergency department visits, and hospice care.

    Measured: Up to 24 months

  12. Number of Participants Categorized Based on Reason for Dose Reduction of Ixazomib Therapy

    Measured: Up to 24 months

  13. Number of Participants Categorized Based on Reason for Interruption of Ixazomib Therapy

    Measured: Up to 24 months

  14. Number of Participants Categorized Based on Reason for Discontinuation of Ixazomib Therapy

    Measured: Up to 24 months

  15. Relative Dose Intensity (RDI)

    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).

    Measured: Up to 24 months

  16. Number of Participants who Experience at Least one Adverse Event (AE)

    Measured: Up to 24 months

  17. Number of Participants Categorized Based on Occurrence of Second Primary Malignancies (SPM)

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2021
  2. Study start29 Oct 2021
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05013190
Sponsor's protocol ID
C15058
Status last verified
Sep 2026
First submitted
18 Aug 2021
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Chen W, Liu A, Li L. The MODIFY Study Protocol: An Open-Label, Single-Arm, Multicenter, Prospective Pragmatic Study of Ixazomib-Based Triple-Drug Therapy in Chinese Patients with Multiple Myeloma. Adv Ther. 2023 Feb;40(2):705-717. doi: 10.1007/s12325-022-02355-3. Epub 2022 Dec 4.

    PubMed 36463561

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Myeloma, run by Takeda at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) at 24 Months (time frame: From the date of first administration of ixazomib therapy to the date of first documentation of PD or death, lost to follow-up, whichever occurs first (up to 24 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05013190, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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