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

Multiple Myeloma Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

• NCT number: NCT01177735
• Study type: Interventional
• Source: University of Arkansas
• Status: Completed
• Phase: Phase 2
• Start date: October 2011
• Completion date: September 2013