Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04895917
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2021-05-10
Brief Title:
Daratumumab and Pomalidomide in Previously Treated Patients With AL Amyloidosis
Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Organization:
Fondazione IRCCS Policlinico San Matteo di Pavia
Study Overview
Official Title:
A Multi-center Open Label Phase II Study of Daratumumab and Pomalidomide in Previously Treated Patients With AL Amyloidosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
DarPAL
Brief Summary:
This study aims at establishing a new powerful combination of daratumumab and pomalidomide as rescue treatment for patients with RR AL amyloidosis
Detailed Description:
Despite recent advance in understanding the biology of the amyloidogenic clone and despite the availability of different therapeutic options there are still patients who fail to respond to fist line therapy and experience relapse after response to first line regimens The toxicity profile of daratumumab resulted favorable in the setting of advanced AL amyloidosis patients with severe organ damage Pomalidomide has proven to be effective as a single agent in RR AL amyloidosis with a better safety profile over lenalidomide because of relevant renal toxicity of the latter drug in presence of nephrotic proteinuria Daratumumab is a recently released mAb that has shown deep hematological responses in RR multiple myeloma with a favorable toxicity Up-to-date clinical data have further demonstrated the high efficacy of combination regimens including an ImiDDaratumumab combination in RR multiple myeloma reaching unprecedented results in terms of response rate progression free survival PFS and minimal residual disease MRD negativity
On these bases the present study aims to explore the doublet Daratumumabpomalidomide in RR AL amyloidosis The goal of the study is to obtain rapid durable and deep hematological responses with a low toxicity profile The expectation is to attain a very favorable benefitrisk ratio from this combination as these patients should experience a low rate of treatment discontinuation hospitalization due AEs andor disease progression andor organ failures
On these bases the present study aims to explore the doublet Daratumumabpomalidomide in RR AL amyloidosis The goal of the study is to obtain rapid durable and deep hematological responses with a low toxicity profile The expectation is to attain a very favorable benefitrisk ratio from this combination as these patients should experience a low rate of treatment discontinuation hospitalization due AEs andor disease progression andor organ failures
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