Clinical Trials Logo

Clinical Trial Summary

This study aims at establishing a new powerful combination of daratumumab and pomalidomide as rescue treatment for patients with R/R AL amyloidosis.


Clinical Trial 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 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04895917
Study type Interventional
Source IRCCS Policlinico S. Matteo
Contact Paolo Milani, MD, PhD
Phone 00390382502994
Email p.milani@smatteo.pv.it
Status Recruiting
Phase Phase 2
Start date June 23, 2021
Completion date March 31, 2024

See also
  Status Clinical Trial Phase
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
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 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
Enrolling by invitation NCT04210791 - Autologous Stem Cell Transplantation for Patients With AL Amyloidosis