CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 656 enrolled
Drug / intervention
Ixazomib Citrate +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.

Search/NCT02181413
NCT02181413Phase 3Completed
CompareCT.gov

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

Takeda·interventional·Posted Jul 4, 2014·Updated Nov 19, 2024

In Brief

A Phase 3 clinical trial evaluating Ixazomib Citrate and Placebo for Multiple Myeloma and Autologous Stem Cell Transplant. Completed, enrolled 656 participants across 227 sites in 33 countries.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma, Autologous Stem Cell Transplant
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 4, 2014
Enrollment StartJul 16, 2014
Primary CompletionApr 16, 2018
Study CompletionSep 8, 2023
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 12.0 years ago

Interventions

Ixazomib Citratedrug

Ixazomib citrate capsules

Placebodrug

Ixazomib citrate placebo-matching capsules