Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-29 @ 3:41 PM
Study NCT ID:
NCT01177735
Status:
COMPLETED
Last Update Posted:
2021-04-22
First Post:
2010-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pomalidomide in Gene Expression Profiling (GEP)-Defined High-risk Multiple Myeloma
Sponsor:
University of Arkansas
Organization:
Study Overview
Official Title:
Phase II Trial of Pomalidomide in GEP-defined High-risk Multiple Myeloma That is Relapsing or Refractory to Prior Therapy
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UARK 2010-01 | OTHER | UAMS | View |