AL Amyloidosis Clinical Trial
Official title:
A Multi-center Open Label Phase II Study of Daratumumab and Pomalidomide in Previously Treated Patients With AL Amyloidosis.
This study aims at establishing a new powerful combination of daratumumab and pomalidomide as rescue treatment for patients with R/R AL amyloidosis.
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 R/R 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 R/R multiple myeloma with a favorable toxicity. Up-to-date clinical data have further demonstrated the high efficacy of combination regimens including an ImiD/Daratumumab combination in R/R 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 Daratumumab/pomalidomide in R/R 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 benefit/risk ratio from this combination as these patients should experience a low rate of treatment discontinuation, hospitalization due AEs and/or disease progression and/or organ failures. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05451771 -
Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis
|
Phase 1/Phase 2 | |
| Completed |
NCT02574676 -
Quality of Life (QOL) Registry for Patients With AL Amyloidosis
|
||
| Recruiting |
NCT06065852 -
National Registry of Rare Kidney Diseases
|
||
| Active, not recruiting |
NCT05199337 -
Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis
|
Phase 1/Phase 2 | |
| Recruiting |
NCT01758042 -
Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders
|
N/A | |
| Completed |
NCT01409148 -
Radioimmunoimaging of AL Amyloidosis
|
Phase 1 | |
| Active, not recruiting |
NCT04512235 -
A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis
|
Phase 3 | |
| Recruiting |
NCT06383143 -
Promoting Diagnosis and Management of AL in Italy (ProDigALIty)
|
||
| Recruiting |
NCT05277493 -
A Registry of Chinese AL Amyloidosis Patients Treated With Subcutaneous or Intravenous Daratumumab
|
||
| Completed |
NCT02632786 -
The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis
|
Phase 2 | |
| Completed |
NCT02841033 -
Daratumumab for the Treatment of Patients With AL Amyloidosis
|
Phase 1/Phase 2 | |
| Completed |
NCT04304144 -
A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis
|
Phase 2 | |
| Recruiting |
NCT01408225 -
Ohio State University Multiple Myeloma and Amyloidosis Data Registry and Sample Resource
|
||
| Terminated |
NCT02489500 -
Trial of High Dose Melphalan/Stem Cell Transplant With or Without Bortezomib
|
Phase 3 | |
| Completed |
NCT01570387 -
A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis
|
Phase 1/Phase 2 | |
| Terminated |
NCT03154047 -
Study in Subjects With Light Chain (AL) Amyloidosis
|
Phase 2 | |
| Completed |
NCT03236792 -
Ixazomib In Combination With Cyclophosphamide And Dexamethasone for Newly Diagnosed AL Amyloidosis
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04392960 -
Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis
|
N/A | |
| Recruiting |
NCT05898646 -
Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial
|
Phase 2 | |
| Not yet recruiting |
NCT06022939 -
Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis
|
Phase 3 |