CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
MLN9708drug
Likely dose
MLN9708 2.3 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/NCT02168101
NCT02168101Phase 2Completed
CompareCT.gov

Open-Label Study to Determine the Feasibility of MLN9708 as Maintenance After Allogeneic Stem Cell Transplant for Multiple Myeloma, Followed by an Expansion Phase at the Maximum-Tolerated Dose (MTD) - A Phase II Study

SCRI Development Innovations, LLC·interventional·Posted Jun 20, 2014·Updated Feb 27, 2020

In Brief

A Phase 2 clinical trial evaluating MLN9708 for Multiple Myeloma. Completed, enrolled 9 participants across 4 sites.

Detailed Summary

The purpose of the study is to determine the safety of MLN9708 as maintenance therapy following allogeneic stem cell transplant in patients with multiple myeloma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesUnited States
CollaboratorsMillennium Pharmaceuticals, Inc.

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 20, 2014
Enrollment StartSep 1, 2014
Primary CompletionFeb 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 12.0 years ago

Interventions

MLN9708drug

Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive MLN9708 orally (PO) as monotherapy on Days 1, 8, and 15 of each 28-day cycle for 6 cycles. Up to 18 patients will be enrolled in a dose-escalation phase to determine the maximum tolerated dose (MTD). Dose-Escalation Phase: MLN9708 will be administered orally (PO) as monotherapy. Dosing will start at 2.3 mg. If acceptable tolerability is demonstrated, escalations will be made to 3 mg and to a maximum-planned dose (MPD) of 4 mg.