Phase II Trial of Pomalidomide in GEP-defined High-risk Multiple Myeloma That is Relapsing or Refractory to Prior Therapy
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.
Participants will receive testing dosing of Revlimid 25mg for 2 days followed by GEP
sampling. A washout period of at least 24 hours will follow Revlimid prior to starting
single agent Pomalidomide at 4 mg/day, days 1-21 every 28 days.
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS) after initiation of pomalidomide therapy
Progression -free survival (PFS) after initiation of pomalidomide therapy
1 year following initiation of pomalidomide therapy
No
Saad Usmani, MD
Principal Investigator
University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy
United States: Institutional Review Board
UARK 2010-01
NCT01177735
October 2011
August 2013
Name | Location |
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University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy | Little Rock, Arkansas 72205 |