At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 705 enrolled
Drug / intervention
Ixazomib +3 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, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma
In Brief
A Phase 3 clinical trial evaluating Ixazomib, Placebo, and 2 other interventions for Multiple Myeloma. Completed, enrolled 705 participants across 147 sites in 7 countries.
Detailed Summary
The purpose of this study is to provide continued access to ixazomib and/or lenalidomide to participants who are continuing to have clinical benefit and to continue collecting relevant safety data to monitor safety in participants with Newly Diagnosed Multiple Myeloma (NDMM) who are not eligible for stem cell transplant.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesBelgium, Canada, France, New Zealand, Russia, South Korea, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2013
First PostedMay 2013
Primary CompletionDec 2019
Study CompletionJun 2022
TodayJul 2026
First PostedMay 9, 2013
Enrollment StartApr 29, 2013
Primary CompletionDec 2, 2019
Study CompletionJun 24, 2022
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 13.1 years ago
Interventions
Ixazomibdrug
IXAZOMIB capsules.
Placebodrug
IXAZOMIB matching-placebo capsules.
Dexamethasonedrug
Dexamethasone tablets.
Lenalidomidedrug
Lenalidomide capsules.