CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
MLN9708 +3 moredrug
Likely dose
MLN9708 4 mgfrom 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/NCT02477215
NCT02477215Phase 2Completed
CompareCT.gov

Phase I/II Study of Bendamustine and IXAZOMIB (MLN9708) Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma

Parameswaran Hari·interventional·Posted Jun 22, 2015·Updated Oct 22, 2020

In Brief

A Phase 2 clinical trial evaluating MLN9708, Dexamethasone, and 2 other interventions for Multiple Myeloma. Completed, enrolled 38 participants across 1 site.

Detailed Summary

This Phase I/II study is designed to first identify doses of MLN9708 and bendamustine that are associated with an acceptable adverse event profile when delivered together in 28-day cycles. Additionally, the study aims to assess the efficacy of the combination in patients with relapsed/refractory multiple myeloma. Responders (stable disease or more), will continue to receive up to eight cycles total in the absence of further progressive disease.

Study Details

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

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 22, 2015
Enrollment StartOct 9, 2015
Primary CompletionMay 2, 2018
Study CompletionSep 17, 2020
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 11.0 years ago

Interventions

MLN9708drug

4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.

Dexamethasonedrug

40 mg oral on Days 1, 8, 15 of each 28 day cycle.

Bendamustine (multiple dose levels)drug

70 mg/m\^2, 80 mg/m\^2, or 90 mg/m\^2 on days 1 and 2

Bendamustine (MTD)drug

80 mg/m\^2 on days 1 and 2