Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2026-02-26 @ 2:15 AM
Study NCT ID:
NCT06342466
Status:
RECRUITING
Last Update Posted:
2024-12-30
First Post:
2024-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bortezomib, Pomalidomide, Dexamethasone for Systemic AL Amyloidosis
Sponsor:
Jin Lu, MD
Organization:
Study Overview
Official Title:
A Study of Bortezomib, Pomalidomide, Dexamethasone in Patients with Systemic AL Amyloidosis
Status:
RECRUITING
Status Verified Date:
2024-05
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 or previous treated systemic light chain (AL) amyloidosis. Approximately 40 subjects will receive therapy with bortezomib, pomalidomide, and dexamethasone. The primary outcome is hematologic very good partial response and complete response rate at 6 months.
Detailed Description:
Proteasome inhibitor and immunmodulators have synergistic effect for plasma cell dyscrasia. Due to the fact that more than 70-80% of patients with amyloidosis have renal involvement, the application of lenalidomide is limited. Thus, the investigators designed this open-label, multicenter, phase 2 study for newly diagnosed or previously treated systemic AL amyloidosis with bortezomib, pomalidomide and dexamethasone regimen.
Study Oversight
Has Oversight DMC:
False
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?: