Clinical trials: Primary Amyloidosis
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.
Polyneuropathy, Amyloid, Neuropathic Pain
Screening for the Transthyretin-Related Familial Amyloidotic Polyneuropathy (TTR FAP)
An International, multicenter, epidemiological observational study investigating the prevalence of Transthyretin-Related Familial Amyloidotic Polyneuropathy (TTR-FAP) in participants with small fiber polyneuropathy of no obvious…
- Conditions
- Polyneuropathy, Amyloid, Neuropathic Pain, Cardiac Failure, Orthostatic Hypotension
- Trial name
- TRAP2-1 (NCT01705626)
- Where
- 11 sites in Austria, Hungary and 4 more
- Volunteers
- 500 people
- Sponsor
- CENTOGENE GmbH Rostock
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; Systemic
A Study of AT-02 in Subjects With Systemic Amyloidosis.
This is a Phase 2 open-label extension study to evaluate the long-term safety, tolerability, and clinical activity of AT-02. AT-02 is an investigational medicinal product being developed to treat systemic amyloidosis.
- Trial name
- NCT05951049
- Testing
- AT02
- Where
- 4 sites in United States
- Volunteers
- 120 people
- Sponsor
- Attralus, Inc.
Healthy Volunteers
A First-in-Human Study of Single and Multiple Doses of anle138b in Healthy Subjects
The purpose of this study is to determine the safety, tolerability and blood levels of orally administered anle138b in healthy subjects.
- Trial name
- NCT04208152
- Testing
- anle138b
- Where
- United Kingdom
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- MODAG GmbH
Brain Fibrillarab Levels
Positron Emission Tomography (PET) Imaging of Brain Amyloid Compared to Post-Mortem Levels
To determine the level of association between quantitative regional estimates of brain uptake of [18F]flutemetamol and quantitative immunohistochemical regional estimates of brain levels of amyloid estimated from post-mortem…
- Trial name
- NCT01165554
- Testing
- [18F] Flutemetamol
- Where
- United States
- Volunteers
- 203 people
- Sponsor
- GE Healthcare
Relapsed AL Amyloidosis, Refractory AL Amyloidosis
A Phase 1b/2 Study of CAR T Cell Therapy Targeting CD19 and BCMA in Participants With Relapsed or Refractory AL Amyloidosis.
Open-label Phase 1b/2 study with primary objective of this study is to evaluate the safety, tolerability and efficacy of AZD0120 in participants with light chain (AL) amyloidosis.
- Conditions
- Relapsed AL Amyloidosis, Refractory AL Amyloidosis, Light Chain Amyloidosis, Amyloidosis
- Trial name
- ALACRITY (NCT07081646)
- Testing
- AZD0120
- Where
- 18 sites in United States, Canada and 1 more
- Volunteers
- 91 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Immunoglobulin Light Chain (AL) Amyloidosis
A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Immunoglobulin Light Chain (AL) Amyloidosis Receiving Etentamig (ABBV-383) as an Intravenous (IV) Infusion
Immunoglobulin light chain (AL) amyloidosis is the most common form of systemic amyloidosis. AL amyloidosis has many root causes and is characterized by the overproduction of AL that are secreted by clonal bone marrow plasma…
- Trial name
- NCT06158854
- Testing
- ABBV-383 (Etentamig)
- Where
- 23 sites in United States, Australia and 4 more
- Volunteers
- 76 people
- Sponsor
- AbbVie
Relapsed/Refractory Multiple Myeloma, Amyloid Light-chain Amyloidosis
A Study to Investigate Safety and Efficacy With SAR445514 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)
This is a first-in-human (FIH) Phase 1/Phase 2 study for evaluating SAR445514 in monotherapy in participants with relapsed/refractory multiple myeloma (RRMM) and relapsed/refractory light chain amyloidosis (RRLCA).
- Trial name
- NCT05839626
- Testing
- SAR445514
- Where
- 16 sites in Australia, Belgium and 5 more
- Volunteers
- 32 people
- Sponsor
- Sanofi
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
Acquired Factor X Deficiency
A Study Investigating Coagadex in the Treatment AFXD Associated With AL Amyloidosis
The purpose of this study is to evaluate the efficacy and safety of Coagadex in treating active bleeds and to manage peri-operative bleeding in participants with acquired factor X deficiency associated with AL amyloidosis.
- Trial name
- NCT06963216
- Testing
- Coagadex(R)
- Sponsor
- Kedrion S.p.A.
Light Chain (AL) Amyloidosis
Study of NXC-201 CAR-T in Patients With Light Chain (AL) Amyloidosis
Open-label Phase 1b Dose Escalation/Dose Expansion study exploring the safety and efficacy of NXC-201 in patients with relapsed or refractory light chain amyloidosis (AL).
- Trial name
- NEXICART-2 (NCT06097832)
- Testing
- NXC-201 CAR-T
- Where
- 18 sites in United States
- Volunteers
- 45 people
- Sponsor
- Nexcella Inc.
Relapsed or Refractory Multiple Myeloma
Pre-Approval Access Single Patient Request for Talquetamab in Relapsed or Refractory Multiple Myeloma
The purpose of this pre-approval access program is to provide talquetamab for the treatment of participants with relapsed or refractory multiple myeloma.
- Trial name
- NCT05503550
- Testing
- Talquetamab
- Sponsor
- Janssen Research & Development, LLC
Multiple Myeloma, Smoldering Multiple Myeloma
A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide for Multiple Myeloma, Newly Diagnosed AL Amyloidosis, and High-risk Smoldering Multiple Myeloma or JNJ-79635322 in Combination With Pomalidomide for Multiple Myeloma
The primary purpose of this study for Part 1 (Dose Escalation) is to identify the safe effective dose (recommended Phase 2 doses [RP2Ds]) and schedule for JNJ-79635322 treatment regimen in combination with daratumumab with or…
- Conditions
- Multiple Myeloma, Smoldering Multiple Myeloma, Immunoglobulin Light-chain Amyloidosis
- Trial name
- NCT06768489
- Testing
- JNJ-79635322, Daratumumab, Pomalidomide
- Where
- 16 sites in United States, Australia and 3 more
- Volunteers
- 276 people
- Sponsor
- Janssen Research & Development, LLC
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
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.
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.
Amyloidosis
A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis
The study aims to evaluate the efficacy and safety of belantamab mafodotin in combination with cyclophosphamide, bortezomib, and dexamethasone in adult participants with newly diagnosed (ND) AL amyloidosis .
- Trial name
- ALANIS (NCT07224672)
- Testing
- Belantamab mafodotin, Cyclophosphamide, Bortezomib
- Where
- 5 sites in United States, Australia
- Volunteers
- 60 people
- Sponsor
- GlaxoSmithKline
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