Pomalidomide in Gene Expression Profiling (GEP)-Defined High-risk Multiple Myeloma
Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
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.