CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 722 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.

Search/NCT01564537
NCT01564537Phase 3Completed

A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral Ixazomib (MLN9708) Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma

Takeda·interventional·Posted Mar 28, 2012·Updated Mar 10, 2023

In Brief

A Phase 3 clinical trial evaluating Ixazomib, Lenalidomide, and 2 other interventions for Relapsed Multiple Myeloma and Refractory Multiple Myeloma. Completed, enrolled 722 participants across 24 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine whether the addition of oral ixazomib to the background therapy of lenalidomide and dexamethasone improves progression free survival (PFS) in participants with relapsed and/or refractory multiple myeloma (RRMM).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 28, 2012
Enrollment StartAug 1, 2012
Primary CompletionOct 1, 2014
Study CompletionFeb 8, 2022
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.3 years ago

Interventions

Ixazomibdrug

Ixazomib capsules

Lenalidomidedrug

Lenalidomide capsules

Dexamethasonedrug

Dexamethasone tablets

Placebodrug

Ixazomib placebo-matching capsules