The purpose of this study is to determine the long-term safety and tolerability of ixazomib
The drug being tested in this study is called ixazomib. Ixazomib is being tested to slow
disease progression and improve overall survival in Chinese participants who have newly
diagnosed multiple myeloma (NDMM) who have had a major positive response to initial therapy
and have not undergone stem cell transplantation (SCT). This study will look at the effect of
ixazomib has on the length of time that participants are free of disease progression and
their overall survival. After the implementation of Amendment 8, participants who received
placebo-matching capsules before unblinding and have not yet experienced disease progression
will cross over to receive ixazomib.
The study will enroll approximately 30 patients. Participants will be assigned to a single
All participants will be asked to take one capsule on Days 1, 8, and 15 of every 28-day
cycle, for up to 26 cycles or until documented PD or intolerable toxicity, whichever occurs
This multi-center trial will be conducted in China. The overall time to participate in this
study is until a total of approximately up to 67 months. Participants will make multiple
visits to the clinic, and every 4 weeks until the next line of therapy begins for a follow-up
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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