Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-25 @ 6:30 PM
Study NCT ID:
NCT06682156
Status:
RECRUITING
Last Update Posted:
2024-11-12
First Post:
2024-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conversion to Carfilzomib Therapy in Bortezomib Intolerant Newly Diagnosed Multiple Myeloma(NDMM) Patients
Sponsor:
The First Affiliated Hospital of Soochow University
Organization:
Study Overview
Official Title:
Clinical Outcome of Multiple Myeloma Patients Switching to Carfilzomib-based Regimens After Prior Bortezomib-based First-line Therapy Intolerant, a Real-world, Single-arm, Prospective Study
Status:
RECRUITING
Status Verified Date:
2024-04
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 an open-label, single-arm, prospective study conducted in real-world clinical practice. It aims to evaluate the efficacy and safety in Chinese patients with newly diagnosed multiple myeloma who switch to carfilzomib-based regimens after bortezomib-based triple-drug regimen intolerance happens.
Detailed Description:
This is an open-label, single-arm, prospective study conducted in real-world clinical practice. Chinese patients with newly diagnosed multiple myeloma will be enrolled if they switch to carfilzomib-based regimens after bortezomib-based triple-drug regimen intolerance happens.
Induction and consolidation therapy will be 6-8cycles. 6 cycles for transplant recipients and 8 cycles for non-transplant recipients. Maintenance therapy will continue until progression.
It aims to evaluate the efficacy and safety of carfilzomib based therapy in Chinese NDMM patients with intolerance to bortezomib. The primary endpoint is the rate of 2-year pFS and secondary endpoints are the rate of ORR,sCR/CR,VGPR,PR, the rate and duration of MRD, the rate of 2-year OS and safety.
Induction and consolidation therapy will be 6-8cycles. 6 cycles for transplant recipients and 8 cycles for non-transplant recipients. Maintenance therapy will continue until progression.
It aims to evaluate the efficacy and safety of carfilzomib based therapy in Chinese NDMM patients with intolerance to bortezomib. The primary endpoint is the rate of 2-year pFS and secondary endpoints are the rate of ORR,sCR/CR,VGPR,PR, the rate and duration of MRD, the rate of 2-year OS and safety.
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?:
None
Is an FDA AA801 Violation?: