Multiple MyelomaNCT04328662
A Study of Ninlaro in Real World Clinical Practice in China
An observational study of Multiple Myeloma and Neoplasms, Plasma Cell, run by Takeda at 28 sites in China.
Trial summary
The main purpose of this study is to collect additional safety information of ixazomib citrate (Ninlaro) when used to treat multiple myeloma in real world clinical practice in China. Participants will be treated with Ninlaro according to the normal clinical practice during this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Neoplasms, Plasma Cell
- How many people
- 482 participants
- Where
- 28 sitesChina
- Study dates
- 18 May 2020to 13 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Chinese participants with RRMM who have received at least one dose of IRd or non-IRd ixazomib based regimen treatment, and NDMM and non-myeloma who have received at least one dose of ixazomib-based regimen treatment will be observed prospectively.
Who may be able to join
- Undergoing treatment with Ninlaro (of less than 3 months from initial treatment with Ninlaro) or to be prescribed with Ninlaro capsule.
- Participants will be able to sign Informed Consent Form to participate.
Who cannot join
- Currently participates or plans to participate in any interventional clinical trial.
- Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
China28 sites
Beijing Chao-yang Hospital,Capital Medical University
Beijing, Beijing Municipality, 100020
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, 100035
Beijing Chao-yang Hospital,Capital Medical University(Shijingshan)
Beijing, Beijing Municipality, 100043
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
Datong Third People's Hospital
Datong, Shanxi, 037046
Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, 510120
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, 510280
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Hainan General Hospital
Haikou, Hainan, 570311
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Anhui Cancer Hospital
Hefei, Anhui, 230031
Affiliated Hospital of Jining Medical College
Jining, Shandong, 272007
Zhabei Central Hospital, Jing'an District, Shanghai
Shanghai, Shanghai Municipality, 200070
Shaoxing People's Hospital
Shaoxing, Zhejiang, 312099
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Soochow Hongci Blood Disease Hospital
Suzhou, Jiangsu, 215100
Tai'an Central Hospital
Tai’an, Shandong, 271099
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, 030012
Taizhou First People's Hospital
Taizhou, Zhejiang, 318020
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Wuxi People's Hospital
Wuxi, Jiangsu, 214023
Henan Cancer Hospital
Zhengzhou, Henan, 450003
About this study
Official title: A National, Prospective, Non-interventional Study of NINLARO in Real World Clinical Practice
The main purpose of this study is to collect additional safety information of ixazomib citrate (Ninlaro) when used to treat multiple myeloma in real world clinical practice in China. Participants will be treated with Ninlaro according to the normal clinical practice during this study.
Read the detailed description
This is a prospective, non-interventional study in Chinese participants with relapsed refractory multiple myeloma (RRMM), newly diagnosed multiple myeloma (NDMM) and non-myeloma who are undergoing or will receive at least one dose of ixazomib citrate. Data will be collected to assess safety information when NINLARO is used in the real world, based on known risks and missing safety information.
The study will enroll approximately 3000 patients. The data will be collected prospectively as part of routine clinical visits of participants. Participants will be assigned to one of the two observational cohorts:
- Cohort 1: Participants with RRMM
- Cohort 2: Participants with NDMM, RRMM, and Non-myeloma
The multi-center trial will be conducted in China. The overall duration of study will be approximately 64 months. All participants will be followed up for 21 months unless withdrawal of Informed Consent Form, loss of follow-up or death, whichever comes first.
- Conditions
- Multiple Myeloma, Neoplasms, Plasma Cell
- Keywords
- Drug Therapy
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Participants with RRMM | Participants diagnosed with relapsed or refractory multiple myeloma (RRMM) who have received at least one dose of ixazomib plus lenalidomide - low dose dexamethasone (IRd) treatment, will be observed prospectively. Data will be collected from study sites such as clinical departments and pharmacies in hospitals as a part of routine clinical visits of participants to evaluate effectiveness and safety information. | |
| Cohort 2: Participants with NDMM, RRMM, and Non-myeloma | Participants diagnosed with NDMM who have received at least one dose of ixazomib-based regimen treatment, diagnosed with RRMM who have received at least one dose non-IRd ixazomib-based regimens treatment, and diagnosed with non-myeloma who have received at least one dose of ixazomib-based regimens treatment, will be observed prospectively. Data will be collected from study sites such as clinical departments and pharmacies in hospitals as a part of routine clinical visits of participants to evaluate effectiveness and safety information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who Have one or More Adverse Events
Measured: From signing of the informed consent to 60 days after administration of the last dose of NINLARO (Up to Month 64)
Secondary outcomes (6)
Number of Participants Reporting one or More Serious Adverse Events (SAEs), Adverse Drug Reaction (ADRs) and Adverse Events of Special Interest (AESI)
Measured: From signing of the informed consent to 60 days after administration of the last dose of NINLARO (Up to Month 64)
Number of Participants With Dose Adjustments During the Study
Measured: Up to Month 64
Number of Participants Categorized by Clinical Characteristics
Measured: Up to Month 64
Number of Participants Based on Disease Characteristics
Measured: Up to Month 64
Number of Participants With Multiple Myeloma Treatment
Measured: Up to Month 64
Overall Survival (OS)
OS is measured as the time from the date of sign Informed Consent Form to the date of death due to any cause.
Measured: From the date of sign Informed Consent Form to the date of death due to any cause (Up to Month 64)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start18 May 2020
- Primary completion13 Feb 2026
- Study completion13 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 482 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328662
- Sponsor's protocol ID
- C16050
- Other IDs
- U1111-1237-5126, EUPAS30733
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2020
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National, Prospective, Non-interventional Study of NINLARO in Real World Clinical Practice
- ClinicalTrials.gov ID
- NCT04328662
- Acronym / sponsor ID
- C16050
- Conditions
- Multiple Myeloma, Neoplasms, Plasma Cell
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 482 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 18 May 2020 (actual)
- Primary completion
- 13 Feb 2026 (actual)
- Study completion
- 13 Feb 2026 (actual)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to collect additional safety information of ixazomib citrate (Ninlaro) when used to treat multiple myeloma in real world clinical practice in China. Participants will be treated with Ninlaro according to the normal clinical practice during this study.
Detailed description
This is a prospective, non-interventional study in Chinese participants with relapsed refractory multiple myeloma (RRMM), newly diagnosed multiple myeloma (NDMM) and non-myeloma who are undergoing or will receive at least one dose of ixazomib citrate. Data will be collected to assess safety information when NINLARO is used in the real world, based on known risks and missing safety information.
The study will enroll approximately 3000 patients. The data will be collected prospectively as part of routine clinical visits of participants. Participants will be assigned to one of the two observational cohorts:
- Cohort 1: Participants with RRMM
- Cohort 2: Participants with NDMM, RRMM, and Non-myeloma
The multi-center trial will be conducted in China. The overall duration of study will be approximately 64 months. All participants will be followed up for 21 months unless withdrawal of Informed Consent Form, loss of follow-up or death, whichever comes first.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Participants with RRMM | – | –Participants diagnosed with relapsed or refractory multiple myeloma (RRMM) who have received at least one dose of ixazomib plus lenalidomide - low dose dexamethasone (IRd) treatment, will be observed prospectively. Data will be collected from study sites such as clinical departments and pharmacies in hospitals as a part of routine clinical visits of participants to evaluate effectiveness and safety information. |
| Cohort 2: Participants with NDMM, RRMM, and Non-myeloma | – | –Participants diagnosed with NDMM who have received at least one dose of ixazomib-based regimen treatment, diagnosed with RRMM who have received at least one dose non-IRd ixazomib-based regimens treatment, and diagnosed with non-myeloma who have received at least one dose of ixazomib-based regimens treatment, will be observed prospectively. Data will be collected from study sites such as clinical departments and pharmacies in hospitals as a part of routine clinical visits of participants to evaluate effectiveness and safety information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese participants with RRMM who have received at least one dose of IRd or non-IRd ixazomib based regimen treatment, and NDMM and non-myeloma who have received at least one dose of ixazomib-based regimen treatment will be observed prospectively.
Key inclusion criteria (2 listed)
- Undergoing treatment with Ninlaro (of less than 3 months from initial treatment with Ninlaro) or to be prescribed with Ninlaro capsule.
- Participants will be able to sign Informed Consent Form to participate.
Key exclusion criteria (2 listed)
- Currently participates or plans to participate in any interventional clinical trial.
- Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants who Have one or More Adverse Events
Time frame: From signing of the informed consent to 60 days after administration of the last dose of NINLARO (Up to Month 64)
6 secondary outcomes
Number of Participants Reporting one or More Serious Adverse Events (SAEs), Adverse Drug Reaction (ADRs) and Adverse Events of Special Interest (AESI)
Time frame: From signing of the informed consent to 60 days after administration of the last dose of NINLARO (Up to Month 64)
Number of Participants With Dose Adjustments During the Study
Time frame: Up to Month 64
Number of Participants Categorized by Clinical Characteristics
Time frame: Up to Month 64
Number of Participants Based on Disease Characteristics
Time frame: Up to Month 64
Number of Participants With Multiple Myeloma Treatment
Time frame: Up to Month 64
Overall Survival (OS)
Time frame: From the date of sign Informed Consent Form to the date of death due to any cause (Up to Month 64)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Click here for more information about this trial in easy-to-understand language.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Neoplasms, Plasma Cell, run by Takeda at 28 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants who Have one or More Adverse Events (time frame: From signing of the informed consent to 60 days after administration of the last dose of NINLARO (Up to Month 64)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2026.