Clinical trials: AL Amyloidosis
AL Amyloidosis
Daratumumab for the Treatment of Patients With AL Amyloidosis
Participants with AL Amyloidosis will receive the drug daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month.
- Trial name
- NCT02841033
- Testing
- daratumumab
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Boston Medical Center
AL Amyloidosis
A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis
This study seeks to enroll patients with AL amyloidosis, for whom treatment with one of the standard melphalan chemotherapy-based regimens is either not recommended or is not their preference.
- Trial name
- NCT01570387
- Testing
- Pomalidomide, Dexamethasone
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Boston Medical Center
AL Amyloidosis
Trial of Venetoclax (ABT-199) and Dexamethasone for Relapsed or Refractory Systemic AL Amyloidosis
This is a study to determine the safety, tolerability and maximum tolerated dose of Venetoclax (ABT-199) and dexamethasone in relapsed or refractory amyloid light chain (AL) amyloidosis patients.
- Trial name
- NCT03000660
- Testing
- Venetoclax, Dexamethasone
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Tufts Medical Center
AL Amyloidosis
Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis
The study is being done to see if the combination of bendamustine and dexamethasone will help people with amyloidosis that has returned after standard treatment, and to to estimate the partial hematologic response rate (PHR).
- Trial name
- NCT01222260
- Testing
- Bendamustine, Dexamethasone
- Where
- 6 sites in United States
- Volunteers
- 40 people
- Sponsor
- Columbia University
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.
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.
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 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.
AL Amyloidosis
Trial of High Dose Melphalan/Stem Cell Transplant With or Without Bortezomib
Standard treatment for AL Amyloidosis is high-dose melphalan and stem cell transplant. This study will compare the safety and effectiveness of standard treatment with high-dose melphalan and stem cell transplant, compared with…
- Trial name
- VelRand (NCT02489500)
- Testing
- Bortezomib, Melphalan, Neupogen
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Boston Medical Center
Light Chain (AL) Amyloidosis, Cardiac Involvement
A Trial for the Treatment of Cardiac AL-Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)
Efficacy and safety of epigallocatechin-3-gallate (EGCG) in patients with cardiac amyloid light-chain (AL) amyloidosis. Evaluation of clinical efficacy of EGCG intake using a pretest posttest comparison of left ventricular…
- Trial name
- TAME-AL (NCT02015312)
- Testing
- Epigallocatechin-3-gallate (EGCG)
- Where
- Germany
- Volunteers
- 38 people
- Sponsor
- Florian Michel
AL Amyloidosis
A Trial for Systemic Light-chain (AL) Amyloidosis
In this multi-center phase III trial, untreated patients diagnosed with AL who are not candidates for stem cell transplant with melphalan 200 mg/m2 are the target population. Stage I and II patients will be eligible.
- Trial name
- EMN-03 (NCT01277016)
- Testing
- BMDex
- Where
- Italy
- Volunteers
- 110 people
- Sponsor
- European Myeloma Network B.V.
AL Amyloidosis
Allo SCT in Amyloidosis Non-interventional Study
Light-chain (AL-) amyloidosis is a very rare monoclonal plasma cell disorder with poor prognosis. Rarity of disease has precluded performance of randomized controlled trials comparing various possible treatment modalities.
- Trial name
- NCT02257905
- Where
- 4 sites in France, Germany and 1 more
- Volunteers
- 14 people
- Sponsor
- European Society for Blood and Marrow Transplantation
AL Amyloidosis
Radioimmunoimaging of Light Chain (AL) Amyloidosis
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.
- Trial name
- NCT01815086
- Testing
- Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Tennessee
AL Amyloidosis
Radioimmunoimaging of AL Amyloidosis
The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive monoclonal antibody to document the presence and distribution of amyloid deposits by PET/CT imaging in patients with AL amyloidosis.
- Trial name
- NCT01409148
- Testing
- 124I-labeled monoclonal antibody Mu 11-1F4
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- University of Tennessee
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