A Study of NINLARO® in Chinese Adults With Multiple Myeloma

Study Purpose

The main aim of this study is to check side effects and results in adults with multiple myeloma after switching from a bortezomib-based to an Ixazomib-based treatment. Treatment with NINLARO® will strictly follow the product label.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Who first diagnosed with MM 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. o 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-based triple-drug regimens as frontline treatment, including bortezomib+cyclophosphamide+dexamethasone (VCD), bortezomib+lenalidomide dexamethasone (VRD), bortezomib+doxorubicin+dexamethasone (PAD), bortezomib+thalidomide+dexamethasone (VTD). 4. Must achieve partial response (PR) as defined by IMWG 2016 criteria after bortezomib-based initial therapy. 5. Eastern Cooperative Oncology Group (ECOG) 0-2.

Exclusion Criteria:

1. Received a bortezomib-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 GI 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05013190
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Takeda
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Study Director
Principal Investigator Affiliation Takeda
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Study Website: View Trial Website
Additional Details

This is a non-interventional, prospective study of participants with 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 320 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 unless withdraw of informed consent form, death or lost to follow-up, termination of the study by the sponsor, whichever comes first.

Arms & Interventions

Arms

: Participants With Multiple Myeloma (MM)

Participants diagnosed with MM (Newly Diagnosed Multiple Myeloma [NDMM]) using IMWG criteria and received a bortezomib-based triple-drug regimens for more than 2 cycles as initial therapy will be treated with ixazomib based regimens strictly following NINLARO® label will be observed prospectively for 24 months.

Interventions

Other: - No intervention

This is a non-interventional study.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hematology Department, Hefei, Anhui, China

Status

Recruiting

Address

Hematology Department

Hefei, Anhui, 230000

Site Contact

Site Contact

dingkaiy@126.com

13966672170

Hematology Department, Beijing, Beijing, China

Status

Recruiting

Address

Hematology Department

Beijing, Beijing, 100020

Site Contact

Site Contact

13910107759@163.com

13910107759

Hematology Department, Beijing, Beijing, China

Status

Recruiting

Address

Hematology Department

Beijing, Beijing, 100096

Site Contact

Site Contact

baolilq909@sina.com

13810837430

Hematology Department, Zhengzhou, Henan, China

Status

Recruiting

Address

Hematology Department

Zhengzhou, Henan, 450004

Site Contact

Site Contact

zhuzm@163.com

13603712008

Hematology Department, Zhengzhou, Henan, China

Status

Recruiting

Address

Hematology Department

Zhengzhou, Henan, 450052

Site Contact

Site Contact

jiangzx313@126.com

13838253306

Hematology Department, Hohhot, Inner Mongolia Autonomous Region, China

Status

Not yet recruiting

Address

Hematology Department

Hohhot, Inner Mongolia Autonomous Region, 010050

Site Contact

Site Contact

gaoda72@163.com

13947130473

Hematology Department, Suzhou, Jiangsu, China

Status

Recruiting

Address

Hematology Department

Suzhou, Jiangsu, 215006

Site Contact

Site Contact

fuzhengzheng@suda.edu.cn

13962191404

Hematology Department, Nanchang, Jiangxi, China

Status

Recruiting

Address

Hematology Department

Nanchang, Jiangxi, 330006

Site Contact

Site Contact

yx021021@sina.com

13970038386

Hematology Department, Shenyang, Liaoning, China

Status

Not yet recruiting

Address

Hematology Department

Shenyang, Liaoning, 110022

Site Contact

Site Contact

'yangw@sj-hospital.org'

18940251012

Hematology Department, Qingdao, Qingdao, China

Status

Recruiting

Address

Hematology Department

Qingdao, Qingdao, 266071

Site Contact

Site Contact

zhongyp3352@126.com

13501098223

Hematology Department, Chengdu, Sichuan, China

Status

Not yet recruiting

Address

Hematology Department

Chengdu, Sichuan, 610000

Site Contact

Site Contact

tingniu@sina.com

18980601242

Hematology Department, Tianjin, Tianjin, China

Status

Recruiting

Address

Hematology Department

Tianjin, Tianjin, 300052

Site Contact

Site Contact

florai@sina.com

18622008752