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Clinical Trials in China / NCT05013190
Active, not recruiting Observational

A Study of NINLARO® in Chinese Adults With Multiple Myeloma

NCT05013190 · tracked via the Priya Life Science China tracker
Sponsor
Takeda
Phase
Observational
Started
2021-10-29
Last updated
2026-09-18

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

No intervention

No intervention: This is a non-interventional study.

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 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: 1. Received a bortezomib/carfilzomib-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 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.

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
Anhui Cancer Hospital Hefei Anhui
Beijing Chao-Yang Hospital,Capital Medical University Beijing Beijing Municipality
Beijing Jishuitan Hospital Beijing Beijing Municipality
Henan Province People's Hospital Zhengzhou Henan
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
Affiliated Hospital of Inner Mongolia Medical University Hohhot Inner Mongolia
The First Affiliated Hospital of Soochow University Suzhou Jiangsu
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi
Shengjing Hospital affiliated to China Medical University Shenyang Liaoning
Qingdao Municipal Hospital Qingdao Shandong
West China Hospital, Sichuan University Chengdu Sichuan
Tianjin Medical University General Hospital Tianjin Tianjin Municipality

More Takeda trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05013190 on ClinicalTrials.gov ↗ ← All trials in China