Pomalidomide in Gene Expression Profiling (GEP)-Defined High-risk Multiple Myeloma

Summary

This is a phase II study, open-label, single institution trial of pomalidomide in GEP-defined, high-risk relapsing/refractory multiple myeloma. Prior therapy must have included lenalidomide. Patient accrual is 30 over a 2 year period. Primary objective: * To determine progression-free survival (PFS) after initiation of pomalidomide therapy Secondary objective: * To determine the response rate (CR, n-CR, VGPR) and duration of response after pomalidomide therapy. * To determine gene expression profiling (GEP) changes exerted within 48 hours of initiation of daily pomalidomide dosing. * To determine gene expression profiling (GEP) changes exerted within 48 hours of initiation 3 concurrent days of exposure to lenalidomide. * To determine MRI- and PET-CT-defined CR in studies obtained at baseline and every 6 month examinations.

Timeline

Start

2011-10

Primary completion

2013-09

Completion

2013-09

Drugs

Indications