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Clinical Trial Summary

The purpose of this study is to investigate the real world effectiveness and safety of ixazomib in combination with lenalidomide and dexamethasone (IRd) in patients with relapsed and/or refractory multiple myeloma (RRMM), under conditions of standard medical care. In addition, an exploratory study of biomarkers will be conducted.


Clinical Trial Description

The drug being tested in this study is called Ixazomib. Ixazomib is being tested to treat people who have relapsed and/or refractory multiple myeloma (RRMM) under the conditions of standard medical care. This study is a non-interventional (observational), domestic, multicenter, prospective study in patients with RRMM. This study will look at the effectiveness and safety of ixazomib in combination with lenalidomide and dexamethasone in Japanese patients with RRMM as standard medical care. In addition, an exploratory study of biomarkers will be conducted in this study. The study will enroll approximately 300 patients. All participants will receive Ixazomib + Lenalidomide + Dexamethasone (IRd) therapy as standard medical care. This multi-center trial will be conducted in Japan. The overall time of observational period in this study will be 36 months. For each participant, the observation period will be from the start of IRd therapy until either 24 months after the enrollment date of the final patient to enroll, or until death or withdrawal of consent, whichever is earlier. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03433001
Study type Observational
Source Takeda
Contact
Status Completed
Phase
Start date April 2, 2018
Completion date June 11, 2021

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