Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05909826
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-18
First Post:
2023-02-28
Brief Title:
Carfilzomib Oral Cyclophosphamide and Dexamethasone for RRMM
Sponsor:
Dong-A University Hospital
Organization:
Dong-A University Hospital
Study Overview
Official Title:
A Phase II Study of Carfilzomib Oral Cyclophosphamide and Dexamethasone for Relapsed andor Refractory Multiple Myeloma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
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:
KMM-KCd
Brief Summary:
This study aims to study the efficacy and safety of oral cyclophosphamide in addition to carfilzomib and dexamethadone for RRMM patients who have been previously exposed to lenalidomide combination therapies
Detailed Description:
The survival of multiple myeloma MM patients has been improved significantly owing to the adoption of immunomodulatory agents IMiD and proteasome inhibitors PI However most of the MM patients finally experience relapse of refractoriness of the disease of which patients who relapse after bortezomib and lenalidomide have very poor prognosis Carfilzomib is an irreversible second generation PI which is approved by Korean FDA for RRMM in combination with dexamethasone andor lenalidomide based on the landmark studies ASPIRE and ENDEAVOR studies The addition of intravenous cyclophosphamide to carfilzomib has recently showed a promising result for RRMM patients after bortezomib and lenalidomide In this study cyclophosphamide 50mg orally will be added to carfilzomib once weekly schedule for 21 days daily every 4 weeks The rationale for oral metronomic cyclophosphamide is based on previous experimental studies which has shown that it removes CD4CD25regulatory T cells preserving T and NKT cell funtions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None