Clinical trials: AL Amyloidosis
AL Amyloidosis
Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis
The rationale for this study is to provide additional treatment with NEOD001 for subjects who complete Study NEOD001-001, and to continue to evaluate long term safety and tolerability.
- Trial name
- OLE (NCT02613182)
- Testing
- NEOD001
- Where
- 5 sites in United States
- Volunteers
- 34 people
- Sponsor
- Prothena Biosciences Ltd.
Primary Systemic (AL) Amyloidosis
The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis
This is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm efficacy and safety study in subjects newly diagnosed with AL amyloidosis.
- Trial name
- VITAL (NCT02312206)
- Testing
- NEOD001
- Where
- 79 sites in United States, Australia and 13 more
- Volunteers
- 260 people
- Sponsor
- Prothena Biosciences Ltd.
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc
Light-Chain Amyloidosis
Study of Oral Ixazomib in Adult Participants With Relapsed or Refractory Light Chain Amyloidosis
This study will include participants with previously treated systemic relapsed or refractory light-chain (AL) amyloidosis who require further therapy and will be aimed at determining the safety profile and the maximum tolerated…
- Trial name
- NCT01318902
- Testing
- Ixazomib, Dexamethasone
- Where
- 10 sites in United States, Canada and 3 more
- Volunteers
- 27 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
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.
Amyloidosis
Open-Label Phase 1/2 Study of VELCADE for Injection in Patients With Light-chain (AL)-Amyloidosis
This is a phase 1/2 open-label, dose-escalation study investigating single-agent therapy with VELCADE in patients with previously treated systemic AL-amyloidosis who require further treatment.
- Trial name
- NCT00298766
- Testing
- VELCADE
- Where
- 4 sites in United States
- Volunteers
- 70 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
AL Amyloidosis
Study in Subjects With Light Chain (AL) Amyloidosis
The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who have completed Study NEOD001-201.
- Trial name
- NCT03154047
- Testing
- NEOD001
- Where
- 34 sites in United States, Australia and 8 more
- Volunteers
- 80 people
- Sponsor
- Prothena Biosciences Ltd.
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.
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 Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis
AL amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down.
- Trial name
- NCT04304144
- Testing
- CAEL-101, SoC: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD), Daratumumab
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Amyloidosis
A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis
The purpose of this study is to evaluate the efficacy and safety of daratumumab plus cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in treatment of newly diagnosed amyloid light chain (AL)…
- Trial name
- NCT03201965
- Testing
- Cyclophosphamide, Bortezomib, Dexamethasone, 40 mg
- Where
- 140 sites in United States, Australia and 20 more
- Volunteers
- 416 people
- Sponsor
- Janssen Research & Development, LLC
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
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.
Light Chain (AL) Amyloidosis
A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis
A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.
- Trial name
- AFFIRM-AL (NCT04973137)
- Testing
- Birtamimab, Standard of Care Chemotherapy
- Where
- 110 sites in United States, Australia and 21 more
- Volunteers
- 208 people
- Sponsor
- Prothena Biosciences Ltd.