CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 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/NCT01383928
NCT01383928Phase 2Completed
CompareCT.gov

An Open-Label, Dose-Escalation, Phase 1/2 Study of the Oral Formulation of IXAZOMIB (MLN9708), Administered Twice-weekly in Combination With Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Requiring Systemic Treatment

Millennium Pharmaceuticals, Inc.·interventional·Posted Jun 28, 2011·Updated Mar 21, 2019

In Brief

A Phase 2 clinical trial evaluating Ixazomib, Lenalidomide, and 1 other intervention for Multiple Myeloma. Completed, enrolled 64 participants across 20 sites.

Detailed Summary

The purpose of this study is to determine the safety, tolerability, maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) in phase 1 and to determine the combined response rate of clinical response CR and very good partial response (VGPR) in phase 2 of oral (PO) ixazomib administered twice-weekly in combination with lenalidomide and low-dose dexamethasone in a 21-day cycle in participants with newly diagnosed multiple myeloma (NDDM).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 28, 2011
Enrollment StartOct 31, 2011
Primary CompletionOct 13, 2014
Study CompletionNov 27, 2017
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 15.0 years ago

Interventions

Ixazomibdrug

Ixazomib capsules

Lenalidomidedrug

Lenalidomide capsules

Dexamethasonedrug

Dexamethasone Tablets