At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 706 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Placebo and Ixazomib for Multiple Myeloma. Completed, enrolled 706 participants across 275 sites in 35 countries.
Detailed Summary
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 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 SCT.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, Poland, Portugal, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 2014
Enrollment StartApr 2015
Primary CompletionAug 2019
Study CompletionAug 2022
TodayJul 2026
First PostedDec 9, 2014
Enrollment StartApr 9, 2015
Primary CompletionAug 12, 2019
Study CompletionAug 26, 2022
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 11.6 years ago
Interventions
Placebodrug
Ixazomib placebo-matching capsules.
Ixazomibdrug
Ixazomib capsules.