Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536413
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-27
Brief Title:
ATRA and Carfilzomib in Plasma Cell Myeloma Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase IBII Study Combining All-Trans Retinoic Acid ATRA With Carfilzomib Based Therapy in Plasma Cell Myeloma Patients Refractory to Carfilzomib
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATRA
Brief Summary:
This is a Phase IBII trial that will investigate the safety tolerability and efficacy of combination therapy using All-Trans Retinoic Acid ATRA with Carfilzomib based therapies in plasma cell myeloma also commonly referred as Multiple Myeloma MM in patients considered refractory to proteasome inhibitors PIs Multiple myeloma is an incurable clonal plasma cell disorder that comprises 10 of all hematologic malignancies Over the past 30 years the global prevalence of multiple myeloma has risen to 126 with 85 of diagnoses occurring in patients 55 years of age In the past 15 years survival has improved considerably which is attributed to the development of multiple different classes of medications including proteasome inhibitors Proteasome inhibitors are the foundation of many multiple myeloma treatments in both transplant eligible and ineligible patients for the past 2 decades While proteasome inhibitors have improved both progression free survival PFS and overall survival OS many patients eventually develop disease progression arising from resistance to therapies As a result there is an unmet need to overcome resistance and find ways to enhance multiple myeloma sensitivity to proteasome inhibitor toxicity Carfilzomib a modified peptide epoxyketone that selectively targets intracellular proteasome enzymes is approved in combination with dexamethasone in patients that have received 1 line of therapy or in combination There are few studies assessing ways to enhance carfilzomib-mediated multiple myeloma toxicity All-Trans Retinoic Acid ATRA is an oxidative metabolite of retinol vitamin A and plays an important role in the regulation of cellular proliferation and differentiation In a recent pre-clinical study ATRA was found to enhance sensitivity of carfilzomib-mediated apoptosis in vitro via an interferon beta IFN-β response pathway In the clinical setting ATRA is a well-tolerated drug that has shown little change in the rate of adverse events in early clinical trials with multiple myeloma The investigators hypothesize that ATRA enhances sensitivity of multiple myeloma to carfilzomib therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None