Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418477
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-13
Brief Title:
Daratumumab Bortezomib Cyclophosphamide and Dexamethasone Therapy for Patients with MIDD
Sponsor:
Peking University Peoples Hospital
Organization:
Peking University Peoples Hospital
Study Overview
Official Title:
Daratumumab Bortezomib Cyclophosphamide and Dexamethasone Therapy for Patients with Monoclonal Immunoglobulin Deposition Disease
Status:
RECRUITING
Status Verified Date:
2024-09
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 multicenter Phase 2 study in subjects with newly diagnosed monoclonal immunoglobulin deposition disease treated with daratumumab bortezomib cyclophosphamide and dexamethasone
Detailed Description:
The current study aims to investigate daratumumab bortezomib cyclophosphamide and dexamethasone regimen in patients with newly diagnosed monoclonal immunoglobulin deposition disease Approximately 25 subjects will receive primary therapy with daratumumab-CyBorD The primary endpoint is overall complete hematologic response CHR rate at 6 months
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