Radioimmunoimaging of Light Chain (AL) Amyloidosis

Status Completed

Clinical Trial Summary

The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive monoclonal antibody (mAb) to document the presence and distribution of amyloid deposits by PET/CT imaging in patients with AL amyloidosis.

Clinical Trial Description

To be eligible for this study, patients must have a confirmed diagnosis of AL amyloidosis without significant cardiac (New York Heart Association class IV) disease and not be on kidney dialysis. Additionally, after testing, their blood must not contain antibodies to mouse proteins. The study requires an intravenous infusion, given over 10 minutes, of the radiolabeled antibody, followed 48 hours later by a PET/CT scan. A repeat scan is done 5 days after infusion of the antibody. A 5-ml blood specimen needs to be furnished 4 and 8 weeks after the antibody infusion. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01815086
Study type	Interventional
Source	University of Tennessee
Contact
Status	Completed
Phase	Phase 1
Start date	December 2008
Completion date	July 2013

View Details

See also
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
Recruiting	`NCT04895917` - Daratumumab and Pomalidomide in Previously Treated Patients With AL Amyloidosis	Phase 2
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