Pomalidomide in Gene Expression Profiling (GEP)-Defined High-risk Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT01177735|
Recruitment Status : Completed
First Posted : August 9, 2010
Results First Posted : March 4, 2015
Last Update Posted : November 20, 2017
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.
- To determine progression-free survival (PFS) after initiation of pomalidomide therapy
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Pomalidomide||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Pomalidomide in GEP-defined High-risk Multiple Myeloma That is Relapsing or Refractory to Prior Therapy|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
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.
Other Name: CC-4047
- Progression-free Survival (PFS) After Initiation of Pomalidomide Therapy [ Time Frame: 1 year following initiation of pomalidomide therapy ]Progression -free survival (PFS) after initiation of pomalidomide therapy. Progressive disease is defined as increase of > 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be > 0.5 g/dL); Urine M-component and/or (the absolute increase must be > 200 mg/24 h); Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL; Bone marrow plasma cell percentage; the absolute percentage must be > 10%; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcaemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01177735
|United States, Arkansas|
|University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Saad Usmani, MD||University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy|