Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455748
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-06
Brief Title:
DaratumumabDaratumumab and Hyaluronidase-fihj in Combination With Pomalidomide and Dexamethasone for the Treatment of Patients With Newly Diagnosed AL Amyloidosis a Prospective Multicenter Single-arm Study
Sponsor:
Yongyong MA
Organization:
First Affiliated Hospital of Wenzhou Medical University
Study Overview
Official Title:
DaratumumabDaratumumab and Hyaluronidase-fihj in Combination With Pomalidomide and Dexamethasone for the Treatment of Patients With Newly Diagnosed AL Amyloidosis a Prospective Multicenter Single-arm Study
Status:
RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
This is a prospective and single arm clinical study The goal of this clinical trial is to observe and evaluate the efficacy and safety of Daratumumabdaratumumab and hyaluronidase-fihj in combination with pomalidomide and dexamethasone in the treatment of patients with newly diagnosed AL amyloidosis
Detailed Description:
Primary objective
Hematologic overall remission rate ORR as defined by the criteria in the Chinese Guidelines for the Diagnosis and Treatment of Systemic Light Chain Amyloidosis 2021 edition
Secondary objective
1 organ remission rate as defined by the criteria of the Chinese Guidelines for the Diagnosis and Treatment of Systemic Light-Chain Amyloidosis 2021 Edition hematologic complete remission CR rate very good partial remission VGPR rate progression free survival PFS overall survival OS and negative rate of microscopic residual disease MRD
2 safety of combination therapy regimens
Exploratory purpose
EORTC QLQ-C30
Hematologic overall remission rate ORR as defined by the criteria in the Chinese Guidelines for the Diagnosis and Treatment of Systemic Light Chain Amyloidosis 2021 edition
Secondary objective
1 organ remission rate as defined by the criteria of the Chinese Guidelines for the Diagnosis and Treatment of Systemic Light-Chain Amyloidosis 2021 Edition hematologic complete remission CR rate very good partial remission VGPR rate progression free survival PFS overall survival OS and negative rate of microscopic residual disease MRD
2 safety of combination therapy regimens
Exploratory purpose
EORTC QLQ-C30
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?:
None