NCT01177735

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

Phase II Trial of Pomalidomide in GEP-defined High-risk Multiple Myeloma That is Relapsing or Refractory to Prior Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Pomalidomide is a 2nd generation immunomodulatory agent (IMiD®) with greater efficacy than lenalidomide and with a similar toxicity spectrum. Phase I trials have shown that pomalidomide 1 to 5 mg is well-tolerated1,2. TT3 has been remarkably successful in the management of newly diagnosed MM, inducing CR rates of \>60% and 4-year estimates of overall and event-free survival of 85% and 75%. Of those achieving CR, estimated 4-year CR rate is 85%. TT3 maintenance has been with either VTD in 2003-33 or VRD in 2006-66, so that pomalidomide's role in overcoming refractoriness to lenalidomide can be assessed. Pharmacogenomic investigations comparing GEP data obtained at baseline and 48hr post-treatment have been performed in case of thalidomide, dexamethasone, lenalidomide, bortezomib and melphalan3. Thus, as most patients on TT3 had baseline and 48-hr GEP investigations performed after bortezomib, the opportunity exists to investigate, at the time of relapse, not only a re-challenge with bortezomib with 48hr GEP but also pomalidomide's effect. 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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Pomalidomide	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.

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2010-08-09
• Last updated: 2021-04-22
• Results posted: 2015-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study