Last updated on February 2018

A Study of Oral Ixazomib Maintenance Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation

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 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).

Detailed Study Description

The drug being tested in this study is called ixazomib citrate. Ixazomib citrate is being tested to slow disease progression and improve overall survival in people 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 citrate has on the length of time that participants are free of disease progression and their overall survival.

The study will enroll approximately 761 patients. Participants will be randomly assigned (by chance, like flipping a coin) 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 citrate 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 each 28-day cycle, for up to 26 cycles.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 24 months. Participants will make 28 visits to the clinic during the treatment period and will continue to make follow-up visits every 4 weeks until the next line of therapy begins. Participants will also be contacted by telephone every 12 weeks after last treatment visit for a follow-up assessment.

Clinical Study Identifier: NCT02312258

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Takeda Study Registration Call Center

National Hospital Organization Kyushu Medical Center
Fukuoka, Japan
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