Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627309
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-29
Brief Title:
Rapid dFLC Response Predict CHR in AL Amyloidosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Rapid dFLC Response Predict Complete Hematologica Response in Systemic AL Amyloidosis Patients Treated With Daratumumab-based Regimen
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Light chain amyloidosis AL amyloidosis is a rare plasma cell dyscrasia characterized by the deposition of insoluble amyloid fibrils in multiple organ systems The treatment of amyloidosis primarily relies on anti-plasma cell therapy and supportive care The application of anti-plasma cell therapy has significantly improved outcomes in patients with AL amyloidosis Standard first-line therapy typically includes daratumumab bortezomib cyclophosphamide and dexamethasone Dara-BCD achieving a complete hematologic response in nearly 60 of patientsThe depth and speed of the hematologic response are strongly correlated with organ response and overall survival An early achievement of a complete hematologic response is particularly crucial in cases of AL amyloidosis characterized by significant organ involvement The median time to a hematologic response for the daratumumab based treatment is only 7-9 days The retrospective data showed that the hematologic response in Day 7 in Cycle 1 C1D7 may predict the complete hematologic response rate In order to validate the conclusion the investigator design this prospective study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None