Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376214
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-03-29
Brief Title:
Daratumumab for Patients With Light Chain Amyloidosis
Sponsor:
Nanjing University School of Medicine
Organization:
Nanjing University School of Medicine
Study Overview
Official Title:
Daratumumab and Dexamethasone Combined With Pomalidomide DPD or ASCT in the Treatment of Newly Diagnosed Systemic Light Chain Amyloidosis AL Amyloidosis a Prospective Single Center Clinical Trial
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 a prospective single-center study exploratory clinical trial aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis patients were divided into three groups one group received long-term treatment with daratumumab based regimen and the other group received autologous stem cell transplantation after two standard treatment courses with daratumumab based regimen and the third group consists of newly diagnosed stage IIIb AL amyloidosis patients who plan to receive DPD treatment The purpose of this study is to observe the efficacy and safety of Daratumumab in the treatment of newly diagnosed systemic AL amyloidosis
Detailed Description:
This is a prospective single-center study exploratory clinical trial aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis patients were divided into three groups one group received long-term treatment with daratumumab based regimen group A and the other group received autologous stem cell transplantation after two standard treatment courses with daratumumab based regimen group B and the third group consists of newly diagnosed stage IIIb AL amyloidosis patients who plan to receive DPD treatment group C Participants with AL Amyloidosis will receive the drug daratumumab by IV infusion once weekly for two months then every 2 weeks for four months then once each month Study treatment may continue until disease progression unacceptable toxicity or decision to withdraw from the trial Disease evaluations will be performed every three months until disease progression Group C were given Daratumumab 16mgkg dexamethasone 40mg and pomalidomide The usage of Daratumumab and dexamethasone is the same as group A and B Patients received oral pomalidomide on days 1-21 of a 28-days cycle from cycle 1 to 6 The dose of pomalidomide is adjusted based on the patients renal function and ECOG score
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