CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 61 enrolled
Drug / intervention
Ixazomib +2 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/NCT01335685
NCT01335685Phase 2Completed

An Open-Label, Dose-Escalation, Phase 1/2 Study of the Oral Form of Ixazomib (MLN9708), a Next-Generation Proteasome Inhibitor, Administered in Combination With a Standard Care Regimen of Melphalan and Prednisone in Patients With Newly Diagnosed Multiple Myeloma Requiring Systemic Treatment

Millennium Pharmaceuticals, Inc.·interventional·Posted Apr 14, 2011·Updated Jan 23, 2018

In Brief

A Phase 2 clinical trial evaluating Ixazomib, Melphalan, and 1 other intervention for Multiple Myeloma. Completed, enrolled 61 participants across 20 sites in 5 countries.

Detailed Summary

The purpose of this phase 1/2, open-label study was to evaluate the effect of oral formulation of Ixazomib when added to standard melphalan and prednisone (MP) treatment. Both phases of the study included participants who had newly diagnosed multiple myeloma and were ineligible for high-dose therapy plus stem cell transplantation because of age (≥65 years of age) or coexisting conditions and for whom standard MP treatment was indicated.

Study Details

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

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 14, 2011
Enrollment StartJun 27, 2011
Primary CompletionDec 29, 2016
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 15.2 years ago

Interventions

Ixazomibdrug

Ixazomib capsules

Melphalandrug

Melphalan tablets

Prednisonedrug

Prednisone tablets