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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
Rochester, MN
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 cells. This is a study to determine adverse events and change in disease activity in adult participants with AL amyloidosis treated with ABBV-383.
Etentamig (ABBV-383) is an investigational drug being developed for the treatment of AL amyloidosis. This study in broken into 2 parts (dose escalation and dose expansion) with 4 arms. During dose escalation (arms 1-3) participants will receive 1 of 3 doses of ABBV-383 ...
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Isatuximab In Treating Patients With Relapsed Or Refractory Primary Amyloidosis
Rochester, MN
This phase II trial studies how well isatuximab works in treating patients with primary amyloidosis that has come back or does not respond to treatment. Monoclonal antibodies, such as isatuximab, may interfere with the ability of cancer cells to grow and spread.
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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
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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) amyloidosis participants.
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A Study to Evaluate Collecting of Health Related Quality of Life Data in Newly Diagnosed AL Amyloidosis Patients
Rochester, MN
The purpose of this study is to evaluate the usefulness of collecting health related quality of life data on newly diagnosed AL amyloidosis patients.
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A Phase 1b/2 Study Of CAR T Cell Therapy Targeting CD19 And BCMA In Participants With Relapsed Or Refractory AL Amyloidosis.
Scottsdale/Phoenix, AZ; Rochester, MN
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.
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Imaging of Systemic Light Chain Cardiac Amyloidosis and Whole-Body Amyloidosis
Jacksonville, FL
The objective of our study is to develop [11C]PIB PET as a new imaging biomarker for quantitative assessment of AL cardiac amyloidosis. The hypothesis is the degree of amyloid deposition in the myocardium and other organs in whole body could be detected and quantified by [11C]PIB PET imaging, which will diagnose cardiac amyloidosis early, differentiate AL cardiac amyloidosis from others, and monitor therapy response.
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A Study To Evaluate The Effectiveness And Safety Of Birtamimab In Mayo Stage IV Patients With AL Amyloidosis
Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of birtamimab plus standard of care compared to placebo plus standard of care in patients with AL amyloidosis in Mayo Stage IV.
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A Study Investigating Coagadex In The Treatment AFXD Associated With AL Amyloidosis
Scottsdale/Phoenix, AZ; Rochester, MN
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.
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A Study To Evaluate The Effectiveness And Safety Of AKCEA-TTR-LRx In Patients With ATTR CM
Scottsdale/Phoenix, AZ; Rochester, MN
To evaluate the effectiveness of AKCEA-TTR-LRx compared to placebo for 120 weeks in patients with ATTR-CM receiving available standard of care (SoC).
For more information, please visit https://www.cardio-ttransform.com/.
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A Study of Chemotherapy in Patients with Immunoglobulin Light (or Heavy) Chain Amyloidosis
Rochester, MN
The aims of this prospective observational study will be to include all patients with systemic AL amyloidosis regardless of age or disease severity, in order to convey a ‘real-world’ picture of the disease, its response to myeloma-type chemotherapy regimens, associated toxicity and outcomes in terms of amyloidotic organ function, quality of life (QoL) and survival.
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ALN-TTR02-012
Jacksonville, FL
To evaluate the effectiveness of Patisiran on ambulatory status in patients with hATTR amyloidosis with polyneuropathy who have a V122I or T60A mutation.
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Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant To Dara-VCD Chemotherapy Alone For People Who Have Newly Diagnosed AL Amyloidosis
Rochester, MN
The purpose of this study compares the effect of adding a stem cell transplant with melphalan after completing chemotherapy with daratumumab, cyclophosphamide, bortezomib and dexamethasone versus chemotherapy with Dara-VCD alone for treating patients with newly diagnosed amyloid light chain amyloidosis.
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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 Amyloidosis
Rochester, MN
The purpose of this study is to evaluate the efficacy (overall CHR rate) of belantamab mafodotin when administered in combination with CyBorD in participants with ND AL amyloidosis. Secondary objectives include the evaluation of other efficacy parameters, safety, PK, immunogenicity, and clinically observable composite endpoints for MOD-PFS of belantamab mafodotin when administered in combination with CyBorD in participants with ND AL amyloidosis.
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A Study of Different Heart Imaging Techniques to Detect Amyloidosis Involving the Heart
Rochester, MN
The purpose of this study is to evaluate different heart imaging techniques to detect amyloidosis involving the heart. We are doing this research study to characterize the differences between types of amyloid and other diseases that mimic the appearance of amyloid involving the heart by using several imaging studies.
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A Study To Evaluate The Effectiveness And Safety Of CAEL-101 In Patients With Mayo Stage IIIa AL Amyloidosis
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if CAEL-101 improves the overall survival in patients with cardiac AL Amyloidosis.
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A Study To Evaluate The Safety And Effectiveness Of CAEL-101 And Plasma Cell Dyscrasia Treatment Vs. Placebo And Plasma Cell Dyscrasia Tretment To Treat Patients With Mayo Stage IIIb AL Amyloidosis
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if CAEL-101 and treatment for plasma cell dyscrasia improves overall survival in Mayo stage IIIb AL amyloidosis patients who are treatment naïve compared to treatment for plasma cell dyscrasia alone, and to evaluate the safety and tolerability of CAEL-101 in combination with treatment for plasma cell dyscrasia.
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A Study To Evaluate APG2575 Combined With Novel Therapeutic Regimens To Treat Subjects With Relapsed Or Refractory Multiple Myeloma And Immunoglobulin Light Chain Amyloidosis
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD and recommended phase II dose (RP2D of APG2575 in combination with Pomalidomide/dexamethasone (Pd) in patients with relapsed/refractory (R/R) multiple myeloma (MM), or immunoglobulin light chain (AL) amyloidosis, and to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD and recommended phase II dose (RP2D of APG2575 in combination with Daratumumab/Lenalidomide/dexamethasone (DRd) in patients with relapsed/refractory (R/R) multiple myeloma (MM).
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A Study To Evaluate The Efficacy And Safety Of AKCEA-TTR-LRx In Participants With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the effectiveness and safety of AKCEA-TTR-LRx after administration for 65 weeks to patients with hereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN), as compared to the NEURO-TTR trial (NCT01737398).
For more information, please visit http://www.neuro-ttransform.com/.