Dose and Schedule Selection of the Oral Proteasome Inhibitor Ixazomib in Relapsed/Refractory Multiple Myeloma: Clinical and Model-Based Analyses.

ABSTRACT:

Background

The oral proteasome inhibitor ixazomib has been approved by regulatory authorities around the world, including in the United States and the European Union, for the treatment of patients with multiple myeloma (MM) who have received at least one prior therapy, based on the pivotal phase III TOURMALINE-MM1 study.

Objective

The objective of this study was to quantitatively characterize the benefit-risk profile of ixazomib in relapsed/refractory MM in support of the approved dose and schedule.

Methods

We report early-phase study data and exposure-response analyses of TOURMALINE-MM1 data that support the selection of the recommended ixazomib dose and schedule.

Results

Single-agent ixazomib studies showed a favorable efficacy/safety profile with weekly vers

SUBMITTER: Gupta N 

PROVIDER: S-EPMC5610674 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature