NCT05013190Active, not recruiting
A Study of NINLARO® in Chinese Adults With Multiple Myeloma
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
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 72 (actual)
- First submitted
- 18 Aug 2021
- Start date
- 29 Oct 2021
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Takeda
- Diseases
- Multiple myeloma
- NCT number
- NCT05013190
What you commit to
- Study type: Observational
- Participants enrolled: 72
- From 29 Oct 2021 to the primary completion date, 31 Dec 2026
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Previously been treated with ixazomib or participated in a study with ixazomib whether treated with ixazomib or not.
Other illness
- 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.
Other
- Has \>=Grade 2 peripheral neuropathy (PN), or Grade 1 with pain on clinical examination at the time of enrollment.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Chao-Yang Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Jishuitan Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Anhui Cancer Hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Affiliated Hospital of Inner Mongolia Medical University Coordinator of this site? Confirm its status | Hohhot | China | Unknown status |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| QingDao Municipal Hospital Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Shengjing Hospital affiliated to China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Henan Province People's Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.