A Study of Real-World Use of Ixazomib Citrate in People With Multiple Myeloma (MM)

Study Purpose

In this study, people with MM will be treated with ixazomib citrate according to their clinic's standard practice. The main aim of the study is to check for side effects from ixazomib citrate.

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 N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Participants with MM. 2. Participants who are prescribed and initiate ixazomib citrate for the treatment of MM according to the ixazomib citrate South Korean product label.

Exclusion Criteria:

1. Participants treated with ixazomib citrate outside of the locally approved label in South Korea. 2. Participants for which ixazomib citrate is contraindicated as per product label.

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.

NCT04840680
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 Korea, Republic of
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, observational post-marketing surveillance study of ixazomib citrate in participants with MM. The study will assess the safety and effectiveness of ixazomib citrate for its approved indications in a clinical practice setting under real-world conditions. The study will enroll approximately 165 participants. The data will be prospectively collected, at the centers from medical files and recorded into electronic case report forms (e-CRFs). All participants will be enrolled in a single observational group: • Participants With MM. The study will be conducted in South Korea. The overall duration of the study will be approximately 6 years and 11 months. Data will be collected over and up to a 6 months-surveillance period (per participant) once enrolled.

Arms & Interventions

Arms

: Participants With MM

Participants with MM who are newly prescribed and will start treatment with ixazomib citrate in a real-world clinical practice setting will be observed prospectively for up to 6 years 11 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

Hallym University Sacred Heart Hospital, Anyang, Korea, Republic of

Status

Recruiting

Address

Hallym University Sacred Heart Hospital

Anyang, , 14068

Site Contact

Site Contact

medinfoUS@takeda.com

031-380-1533

Bucheon, Korea, Republic of

Status

Recruiting

Address

SOONCHUNHYANG UNIVERSITY HOSPITAL Bucheon

Bucheon, , 14584

Site Contact

Site Contact

medinfoUS@takeda.com

032-621-5191

Inje University Busan Paik Hospital, Busan, Korea, Republic of

Status

Recruiting

Address

Inje University Busan Paik Hospital

Busan, , 47392

Site Contact

Site Contact

medinfoUS@takeda.com

051-890-6987

Pusan National University Hospital, Busan, Korea, Republic of

Status

Recruiting

Address

Pusan National University Hospital

Busan, , 49241

Site Contact

Site Contact

medinfoUS@takeda.com

051-240-8170

Kosin University Gospel Hospital, Busan, Korea, Republic of

Status

Recruiting

Address

Kosin University Gospel Hospital

Busan, , 49267

Site Contact

Site Contact

medinfoUS@takeda.com

051-990-5820

Kyungpook National University Hospital, Daegu, Korea, Republic of

Status

Recruiting

Address

Kyungpook National University Hospital

Daegu, , 41944

Site Contact

Site Contact

medinfoUS@takeda.com

053-200-5570

Keimyung University Dongsan Hospital, Daegu, Korea, Republic of

Status

Recruiting

Address

Keimyung University Dongsan Hospital

Daegu, , 42601

Site Contact

Site Contact

medinfoUS@takeda.com

053-258-7713

Chungnam National Unversity Hospital, Daejeon, Korea, Republic of

Status

Recruiting

Address

Chungnam National Unversity Hospital

Daejeon, , 35015

Site Contact

Site Contact

medinfoUS@takeda.com

042-280-6501

Hwasun, Korea, Republic of

Status

Recruiting

Address

Chonnam National University Hwasun Hospital

Hwasun, , 58128

Site Contact

Site Contact

medinfoUS@takeda.com

061-379-7863

Incheon, Korea, Republic of

Status

Recruiting

Address

The Catholic University of Korea, Incheon ST. Marys Hospital

Incheon, , 21431

Site Contact

Site Contact

medinfoUS@takeda.com

1544-9004

Korea University Anam Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Korea University Anam Hospital

Seoul, , 02841

Site Contact

Site Contact

medinfoUS@takeda.com

02 920 5713

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seoul, , 03080

Site Contact

Site Contact

medinfoUS@takeda.com

02-2072-0707

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seoul, , 03080

Site Contact

Site Contact

medinfoUS@takeda.com

02-6072-5179

Samsung medical center, Seoul, Korea, Republic of

Status

Recruiting

Address

Samsung medical center

Seoul, , 06351

Site Contact

Site Contact

medinfoUS@takeda.com

02-2148-7690

Seoul, Korea, Republic of

Status

Recruiting

Address

The Catholic University of Korea Seoul ST. Mary's Hospital

Seoul, , 06591

Site Contact

Site Contact

medinfoUS@takeda.com

02-2258-7488

Chung-Ang University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Chung-Ang University Hospital

Seoul, , 06973

Site Contact

Site Contact

medinfoUS@takeda.com

02-6299-2951

Ewha womans university medical center, Seoul, Korea, Republic of

Status

Recruiting

Address

Ewha womans university medical center

Seoul, , 07985

Site Contact

Site Contact

medinfoUS@takeda.com

1666-5000

Korea University Guro Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Korea University Guro Hospital

Seoul, , 08308

Site Contact

Site Contact

medinfoUS@takeda.com

02-2626-2286

Ajou University Hospital, Suwon, Korea, Republic of

Status

Recruiting

Address

Ajou University Hospital

Suwon, , 16499

Site Contact

Site Contact

medinfoUS@takeda.com

031-219-5965

Wonju, Korea, Republic of

Status

Recruiting

Address

Yonsei University Wonju Severance Christian Hospital

Wonju, , 26426

Site Contact

Site Contact

medinfoUS@takeda.com

033-741-0874

Yongin Severance Hospital, Yongin, Korea, Republic of

Status

Recruiting

Address

Yongin Severance Hospital

Yongin, , 16995

Site Contact

Site Contact

medinfoUS@takeda.com

031-5189-8965