A Study of NINLARO® in Chinese Adults With Multiple Myeloma
NCT ID: NCT05013190
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
72 participants
OBSERVATIONAL
2021-10-29
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No intervention
This is a non-interventional study.
Interventions
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No intervention
This is a non-interventional study.
Eligibility Criteria
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Inclusion 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.
a. 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 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).
4. Must achieve at least partial response (PR) as defined by IMWG criteria after bortezomib/carfilzomib-based initial therapy.
5. Eastern Cooperative Oncology Group (ECOG) 0-2.
Exclusion Criteria
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 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.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Anhui Cancer Hospital
Hefei, Anhui, China
Beijing Chao-Yang Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China
Henan Province People Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhenzhou University
Zhengzhou, Henan, China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning, China
Qingdao Municipal Hospital
Qingdao, Qingdao, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Countries
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References
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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.
Related Links
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To obtain more information on the study, click on this link.
Other Identifiers
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C15058
Identifier Type: -
Identifier Source: org_study_id
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