Multiple Myeloma Clinical Trial
Official title:
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation
The purpose of this study is to determine the effect of ixazomib maintenance therapy on
progression-free survival (PFS) compared with placebo, in participants in China with newly
diagnosed multiple myeloma (NDMM) who have had a major response [complete response (CR), very
good partial response (VGPR), or partial response (PR)] to initial therapy and who have not
undergone stem-cell transplantation (SCT).
This study is a China continuation of the global study C16021 (NCT02312258).
29-Apr-2020 Enrollment of new patients into this study has been paused due to the COVID-19
situation. The duration of this pause is dependent on the leveling and control of the
COVID-19 pandemic.
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.
The study will enroll approximately 105 patients. Participants will be randomly assigned (by
chance, like flipping a coin) in 3:2 ratio to one of the two treatment groups—which will
remain undisclosed to the patient and study doctor during the study (unless there is an
urgent medical need):
- Ixazomib 3 mg
- Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has
no active ingredient
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
first.
This multi-center trial will be conducted in China. The overall time to participate in this
study is until a total of approximately 60 death events have been reported for Chinese
participants or FA for OS in the global study (approximately up to 88 months). Participants
will make multiple visits to the clinic, and every 4 weeks until the next line of therapy
begins for a follow-up assessment.
;
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