Clinical trials: Light Chain Amyloidosis
AL Amyloidosis
The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis
This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered intravenously in adults with AL amyloidosis who…
- Trial name
- PRONTO (NCT02632786)
- Testing
- NEOD001
- Where
- 40 sites in United States, Australia and 8 more
- Volunteers
- 129 people
- Sponsor
- Prothena Biosciences Ltd.
AL Amyloidosis
Study of Chimeric Fibril-Reactive Monoclonal Antibody 11-1F4 in Patients With AL Amyloidosis
The purpose of this study is to examine the tolerance, safety, pharmacokinetics, and possible clinical benefit of the good manufacturing practice (GMP)-grade amyloid fibril-reactive chimeric (Ch) IgG1 mAb 11-1F4 in patients with…
- Trial name
- NCT02245867
- Testing
- Chimeric Fibril-Reactive Monoclonal Anti-body 11-1F4
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
AL Amyloidosis, Amyloidosis
Quality of Life (QOL) Registry for Patients With AL Amyloidosis
This is an online registry to document the psychometric properties of SF-36v2 among patients with AL Amyloidosis, to document patients' burden of disease, to better understand the patient's experience and to follow quality of…
- Trial name
- NCT02574676
- Testing
- non-interventional
- Where
- United States
- Volunteers
- 343 people
- Sponsor
- Prothena Biosciences Ltd.
Cardiac Amyloidosis, AL Amyloidosis
Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis
This is an open-label, multi-center pivotal Phase 3 study to visually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with suspected cardiac…
- Conditions
- Cardiac Amyloidosis, AL Amyloidosis, ATTR Amyloidosis
- Trial name
- CArdiag (NCT05184088)
- Testing
- [18F]florbetaben
- Where
- 14 sites in United States, Germany and 2 more
- Volunteers
- 244 people
- Sponsor
- Lantheus Germany GmbH
Amyloid Light Chain (AL) Amyloidosis
Study to Evaluate Change in Disease Activity and Adverse Events of Subcutaneous Etentamig Compared With Daratumumab Plus Cyclophosphamide Plus Bortezomib Plus Dexamethasone (Dara-CyBorD) in Adults With Amyloid Light Chain (AL) Amyloidosis
Amyloid light chain (AL) amyloidosis is a rare disease caused by abnormal plasma cells producing misfolded light chain proteins that deposit in organs, leading to organ dysfunction and failure.
- Trial name
- NCT07793422
- Testing
- Etentamig, Daratumumab, Cyclophosphamide
- Volunteers
- 370 people
- Sponsor
- AbbVie
Amyloidosis, Systemic Light Chain Amyloidosis
A Safety Study of Carfilzomib in Patients With Previously-Treated Systemic Light Chain Amyloidosis
This is a dose finding study to evaluate the safety and determine the maximum tolerated dose of carfilzomib in patients with previously treated systemic light-chain amyloidosis.
- Trial name
- NCT01789242
- Testing
- Carfilzomib, Dexamethasone
- Where
- 10 sites in United States
- Volunteers
- 32 people
- Sponsor
- Criterium, Inc.
Amyloidosis
A Safety Study of GSK3039294 in Healthy Volunteers and Patients With Systemic Amyloidosis
GSK3039294 has been developed in order to offer an orally available alternative to parenteral CPHPC (GSK2315698 [metabolite of GSK3039294]) for plasma serum amyloid P component (SAP) depletion prior to use of anti SAP monoclonal…
- Trial name
- NCT02603172
- Testing
- GSK3039294
- Where
- United Kingdom
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
AL Amyloidosis
A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis (CARES)
AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down.
- Trial name
- NCT04504825
- Testing
- CAEL-101, cyclophosphamide, bortezomib, and Dexamethasone (CyBorD) regimen
- Where
- 90 sites in United States, Australia and 17 more
- Volunteers
- 125 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
AL Amyloidosis
A Clinical Study of Melphalan Flufenamide (Melflufen) and Dexamethasone for Patients With Immunoglobulin Light Chain (AL) Amyloidosis
This is a phase 1/2 open label study of melphalan flufenamide (melflufen) in combination with dexamethasone for participants with Al amyloidosis following at least one prior line of therapy.
- Trial name
- NCT04115956
- Testing
- Melphalan-Flufenamide (Melflufen), Dexamethasone
- Where
- 9 sites in United States, Czechia and 7 more
- Volunteers
- 6 people
- Sponsor
- Oncopeptides AB
Relapsed or Refractory Systemic Light Chain Amyloidosis
Study of Dexamethasone Plus IXAZOMIB (MLN9708) or Physicians Choice of Treatment in Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis
The purpose of this study is to provide continued access of ixazomib and/or other study medications and to continue collecting relevant safety data to monitor participant's safety, determine whether dexamethasone plus IXAZOMIB…
- Trial name
- NCT01659658
- Testing
- IXAZOMIB, Dexamethasone, Melphalan
- Where
- 66 sites in United States, Australia and 13 more
- Volunteers
- 177 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
AL Amyloidosis
A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis (CARES)
AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down.
- Trial name
- NCT04512235
- Testing
- CAEL-101, cyclophosphamide, bortezomib, and dexamethasone (CyBorD) regimen
- Where
- 110 sites in United States, Australia and 17 more
- Volunteers
- 281 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Primary Amyloidosis
Phase 1/2, Open Label, Dose Escalation Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis
Dose escalation study to determine the maximum tolerated dose of NEOD001 in approximately 30 subjects with AL amyloidosis. Expansion phase to evaluate safety, efficacy and pharmacokinetics of NEOD001 in 25 additional subjects at…
- Trial name
- NCT01707264
- Testing
- NEOD001
- Where
- 7 sites in United States
- Volunteers
- 69 people
- Sponsor
- Prothena Biosciences Ltd.
Amyloidosis
A Study to Evaluate the Safety of GSK2398852 When Co-administered With GSK2315698 in Patients With Systemic Amyloidosis
The study will be conducted in two parts. The first (Part A) will be an open label single dose escalation part beginning with the proposed starting dose level of GSK2398852 as 5 milligram (mg) [approximately equivalent to 0.1…
- Trial name
- NCT01777243
- Testing
- GSK2398852, GSK2315698
- Where
- 2 sites in United Kingdom
- Volunteers
- 25 people
- Sponsor
- GlaxoSmithKline
Relapsed or Refractory Multiple Myeloma, Previously Treated Amyloid Light-chain (AL) Amyloidosis
A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis
The primary purpose of this study is to identify the recommended phase 2 dose (RP2D[s]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at…
- Trial name
- NCT05652335
- Testing
- JNJ-79635322
- Where
- 29 sites in United States, Belgium and 5 more
- Volunteers
- 180 people
- Sponsor
- Janssen Research & Development, LLC
Amyloidosis, AL Amyloidosis
Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis
This is a single arm, Open-Label, Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis.
- Trial name
- NCT05199337
- Testing
- ZN-d5
- Where
- 21 sites in United States, Australia and 5 more
- Volunteers
- 18 people
- Sponsor
- K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
Multiple Myeloma, Amyloidosis
APG-2575 in Combination With Novel Therapeutic Regimens in Subjects With Relapsed or Refractory Multiple Myeloma
This is a Phase Ib/II, open-label, multi-center study evaluating the safety, tolerability, efficacy, and PK/ Pharmacodynamics of APG-2575 in combination with Pd/DRd in patients with relapsed/refractory (RR) multiple myeloma (MM).
- Trial name
- NCT04942067
- Testing
- APG-2575+ Pd, APG-2575 + DRd
- Where
- 3 sites in United States
- Volunteers
- 108 people
- Sponsor
- Ascentage Pharma Group Inc.
Amyloidosis
A Study to Evaluate Organ Level Uptake Repeatability of 124I AT-01 in Subjects With Systemic Amyloidosis
This study is designed to assess the repeatability of organ-specific quantitation of radiotracer uptake following Positron Emission Tomography/Computed Tomography (PET/CT) imaging of AT- 01 in subjects with amyloid light chain…
- Trial name
- AT01-001 (NCT05235269)
- Testing
- 124I-AT-01
- Where
- 3 sites in United States
- Volunteers
- 33 people
- Sponsor
- Attralus, Inc.
Amyloidosis; Systemic
A Study to Characterize the Biodistribution of 124I-Labeled AT-03 in Patients With Systemic Amyloidosis
This is a single center Phase 1 study is to evaluate the biodistribution of radiolabeled AT-03 in patients with systemic amyloidosis.
- Trial name
- AT03-001 (NCT05201911)
- Testing
- 124I-AT03
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Attralus, Inc.
Primary Light-Chain Amyloidosis
Study Evaluating the Efficacy and Safety of CM336 Injection in the Treatment of Light-Chain Amyloidosis
to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Relapsed or Refractory Primary Light-Chain Amyloidosis
- Trial name
- NCT07039578
- Testing
- CM336 Injection(Low dose group), CM336 Injection(High dose group)
- Where
- 2 sites in China
- Volunteers
- 90 people
- Sponsor
- Keymed Biosciences Co.Ltd
AL Amyloidosis
Study of Eque-cel CAR-T Therapy in Newly Diagnosed Severe AL Amyloidosis
The goal of this clinical trial is to learn if Equecabtagene Autoleucel(Eque-cel), a Chimeric Antigen Receptor T-cell (CAR-T) therapy, works to treat severe Light Chain (AL) Amyloidosis in newly diagnosed adults with Mayo Stage…
- Trial name
- NCT07055724
- Testing
- Eque-cel CAR-T Therapy
- Volunteers
- 17 people
- Sponsor
- Nanjing IASO Biotechnology Co., Ltd.