Last updated on May 2020

A Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Participants With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation (SCT)

Brief description of study

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).

Detailed Study Description

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 groupswhich 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.

Clinical Study Identifier: NCT03748953

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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