A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant
The purpose of this study is to determine the effect of ixazomib citrate maintenance therapy on progression-free survival (PFS), compared to placebo, in participants with newly diagnosed multiple myeloma (NDMM) who have had a response (complete response [CR], very good partial response [VGPR], or partial response [PR]) to induction therapy followed by high-dose therapy (HDT) and autologous stem cell transplant (ASCT).
The investigational 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 NDMM who have had any type of positive response to induction therapy followed by HDT and ASCT. 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 652 participants. Participants will be randomly assigned (by chance, like flipping a coin) 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 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 (approximately 24 months).
This multi-center trial will be conducted globally. The overall time to participate in this study is up to 107 months. Participants will make 28 visits to the clinic during the treatment period and will continue to make visits in the 4 follow-up periods (PFS, PD, PFS2, and OS). Participants will be assessed for disease response and PD during the PFS Follow-up period and undergo follow up every 4 weeks until the next line of therapy begins. Participants who start the next line of therapy will enter the PFS2 Follow-up period. During the PFS2 Follow-up period, follow-up will occur every 12 weeks until PD2 occurs. After participants in the PFS2 Follow-up period have PD2 on next-line therapy, they enter the OS Follow-up period. During the OS Follow-up period, follow-up will occur every 12 weeks until death or termination of the study.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 656 participants
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Patients With Multiple Myeloma Following Autologous Stem Cell Transplant
Actual Study Start Date: June 30, 2014
Actual Primary Completion Date: May 1, 2018
Estimated Study Completion Date: June 25, 2025
- Experimental: Ixazomib Citrate
- Placebo Comparator: Placebo
|Date last updated at source||2018-05-22|
|Study start date||2014-06-30|
|Estimated primary completion date||2018-05-01|