At a glance
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Phase II Trial of Pomalidomide in GEP-defined High-risk Multiple Myeloma That is Relapsing or Refractory to Prior Therapy
In Brief
A Phase 2 clinical trial evaluating Pomalidomide for Multiple Myeloma. Completed, enrolled 71 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.