Clinical trials: Light Chain (AL) Amyloidosis
Light Chain (AL) Amyloidosis
An Open-Label Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With AL Amyloidosis
This is a Phase 1 open-label, dose escalation trial designed to identify the recommended phase 2 dose of STI-6129 by assessing the safety, preliminary efficacy, and immunogenicity in subjects with relapsed or refractory systemic…
- Trial name
- NCT05692908
- Testing
- STI-6129
- Sponsor
- Sorrento Therapeutics, Inc.
AL Amyloidosis, Multiple Myeloma
SMS-Based Remote Symptom Monitoring for Patients With Plasma Cell Disorders
This study evaluates whether daily SMS-based (text messages) symptom monitoring is feasible and acceptable in patients who are undergoing treatment for multiple myeloma (MM) or systemic light chain amyloidosis (AL), and whether…
- Trial name
- NCT07850284
- Testing
- Non-Interventional Study
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Mayo Clinic
Multiple Myeloma, AL Amyloidosis
A Phase II Study to Evaluate the Efficacy and Safety of Teclistamab in Combination With Daratumumab (Tec-Dara) in Newly Diagnosed Multiple Myeloma With Concurrent Light Chain Amyloidosis (MM+AL).
The goal of this clinical trial is to learn if teclistamab in combination with daratumumab (Tec-Dara) works to treat newly diagnosed multiple myeloma with concurrent light chain amyloidosis (MM+AL).
- Trial name
- NCT07638683
- Testing
- Teclistamab
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Shanghai Zhongshan Hospital
AL Amyloidosis
Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis
This study aims to evaluate the use of teclistamab in systemic AL amyloidosis and answer whether teclistamab can improve the rate of complete hematological response. This is a single-arm, multi-center, prospective study.
- Trial name
- NCT06699394
- Testing
- Teclistamab (Tec)
- Where
- 2 sites in China
- Volunteers
- 20 people
- Sponsor
- Peking University People's Hospital
AL Amyloidosis
Isatuximab as Upfront Therapy for the Treatment of High Risk AL Amyloidosis
This phase I trial studies the side effects of isatuximab and to see how well it works in treating patients with high risk immunoglobulin light chain amyloidosis (AL amyloidosis).
- Trial name
- NCT04754945
- Testing
- Bortezomib, Cyclophosphamide, Dexamethasone
- Where
- 6 sites in United States
- Volunteers
- 11 people
- Sponsor
- Emory University
Amyloidosis
Bortezomib and Dexamethasone Followed by ASCT Compared With ASCT Alone in Treating Patients With AL Amyloidosis
This randomized phase III trial is studying the side effects and how well giving induction therapy with bortezomib and dexamethasone followed by autologous stem cell transplantation (ASCT) compared with ASCT alone in treating…
- Trial name
- NCT01998503
- Testing
- Bortezomib, dexamethasone, filgrastim
- Where
- China
- Volunteers
- 56 people
- Sponsor
- Nanjing University School of Medicine
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, Smoldering Multiple Myeloma
Promoting Diagnosis and Management of AL in Italy (ProDigALIty)
The investigators plan to establish a dedicated network of Italian Hematologic Departments interconnected with the Amyloidosis Research and Treatment Center in Pavia to: 1.
- Conditions
- AL Amyloidosis, Smoldering Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance
- Trial name
- ProDigALIty (NCT06383143)
- Testing
- no intervention
- Where
- 4 sites in Italy
- Volunteers
- 760 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Light Chain (AL) Amyloidosis, Stage 3B
A Study of Daratumumab Monotherapy in Previously Untreated Patients With Stage 3B Light Chain (AL) Amyloidosis
This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed stage 3B light chain (AL) amyloidosis.
- Trial name
- NCT04131309
- Testing
- Daratumumab, Bortezomib Injection, Dexamethasone oral tablet
- Where
- 5 sites in France, Greece and 2 more
- Volunteers
- 40 people
- Sponsor
- Stichting European Myeloma Network
Amyloid, Cardiac Amyloidosis
Amyloidosis Incidence in High-Risk Cardiac Device Patients
This single-practice prospective cohort study aims to enhance the diagnosis of cardiac amyloidosis in high-risk patients undergoing standard cardiac device implantation.
- Conditions
- Amyloid, Cardiac Amyloidosis, Amyloidosis Cardiac, Systemic Amyloidosis
- Trial name
- NCT06186167
- Testing
- Chest Wall Fat Tissue Collection
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Midwest Heart & Vascular Specialists
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.
AL Amyloidosis
Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis
This will be a systematic, combined, prospective assessment of the novel echographic, CMR, and PET imaging tools in newly-diagnosed patients with cardiac AL amyloidosis at baseline and after treatment.
- Trial name
- NCT04392960
- Testing
- [18F]Florbetaben
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Primary Amyloidosis of Light Chain Type
Pomalidomide and Dexamethasone (PDex) in AL Amyloidosis
The aim of the study is to evaluate the safety and efficacy of Pomalidomide and Dexamethasone in patients who did not achieve a complete response after initial treatment with both an alkylating agent (Melphalan or…
- Trial name
- NCT01510613
- Testing
- Pomalidomide and Dexamethasone
- Where
- Italy
- Volunteers
- 28 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Systemic AL Amyloidosis
Rapid dFLC Response Predict CHR in AL Amyloidosis
Light chain amyloidosis (AL amyloidosis) is a rare plasma cell dyscrasia characterized by the deposition of insoluble amyloid fibrils in multiple organ systems.
- Trial name
- NCT06627309
- Testing
- Dara IV, Bortezomib (drug), Dexamethasone
- Where
- 8 sites in China
- Volunteers
- 50 people
- Sponsor
- Peking University People's Hospital
AL Amyloidosis
A Registry of Chinese AL Amyloidosis Patients Treated With Subcutaneous or Intravenous Daratumumab
The purpose of this protocol is to generate a registry of Chinese patients with AL amyloidosis treated with subcutaneous/intravenous daratumumab alone or subcutaneous/intravenous daratumumab combined with chemotherapy.
- Trial name
- NCT05277493
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Peking Union Medical College Hospital
Multiple Myeloma
Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different ways to stop the growth of abnormal plasma cells, either by killing the cells or by stopping them from dividing.
- Trial name
- MRD (NCT00679367)
- Testing
- dexamethasone, lenalidomide, melphalan
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Boston Medical Center
Amyloidosis; Systemic
Propylene Glycol-Free Melphalan Hydrochloride (Evomela) in AL Amyloidosis Patients
This is a single arm, open label study designed to evaluate the safety and efficacy of propylene glycol-free melphalan hydrochloride in patients with AL amyloidosis.
- Trial name
- NCT02994784
- Testing
- Propylene Glycol-Free Melphalan Hydrochloride
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Boston Medical Center
Multiple Myeloma, AL Amyloidosis
COVID-19 VAX Booster Dosing in Patients With Hematologic Malignancies
To determine whether protective antibody levels increase after booster dosing with the Moderna COVID-19 vaccine in patients diagnosed with Hematologic Malignancies who have low antibody levels after a prior first vaccination with…
- Conditions
- Multiple Myeloma, AL Amyloidosis, Chronic Lymphocytic Leukemia
- Trial name
- NCT05028374
- Testing
- A single "booster" dose of the Moderna mRNA COVID-19 vaccine
- Where
- United States
- Volunteers
- 119 people
- Sponsor
- Barbara Ann Karmanos Cancer Institute
Primary Systemic Amyloidosis (AL)
Intensive Versus Conventional Treatment in Patients With Primary Amyloidosis
AL amyloidosis is caused by a clonal plasma cell dyscrasia and characterized by progressive deposition of amyloid fibrils derived from monoclonal Ig light chains, leading to multisystem organ failure and death.
- Trial name
- NCT00344526
- Testing
- Melphalan, Dexamethasone, Autologous stem cell transplantation
- Where
- 8 sites in France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Limoges
Light Chain (AL) Amyloidosis, CCND1 Translocation
Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis with Translocation (11;14)
Venetoclax is considered as a promising agent for light-chain (AL) amyloidosis due to the high percentage of t(11;14). Several retrospective studies showed venetoclax-based therapy could induce rapid and profound hematologic…
- Conditions
- Light Chain (AL) Amyloidosis, CCND1 Translocation, Venetoclax
- Trial name
- NCT05996406
- Testing
- Venetoclax, Dexamethasone Oral
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Peking Union Medical College Hospital