Primary Systemic (AL) Amyloidosis Clinical Trial
— VITALOfficial title:
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care Versus Placebo Plus Standard of Care in Subjects With Light Chain (AL) Amyloidosis
| Verified date | October 2023 |
| Source | Prothena Biosciences Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm efficacy and safety study in subjects newly diagnosed with AL amyloidosis. Subjects will remain on-study until study completion, which will occur when all primary endpoint events (all-cause mortality or cardiac hospitalizations) have been reached.
| Status | Terminated |
| Enrollment | 260 |
| Est. completion date | May 2018 |
| Est. primary completion date | May 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Key Inclusion Criteria: 1. Age = 18 years 2. Newly diagnosed, AL amyloidosis treatment naïve 3. Bone marrow consistent with plasma cell dyscrasia 4. Confirmed diagnosis of AL amyloidosis 5. Cardiac involvement 6. Planned first-line chemotherapy contains a proteasome-inhibiting agent administered weekly 7. Adequate bone marrow reserve, hepatic and renal function Key Exclusion Criteria: 1. Non-AL amyloidosis 2. Meets diagnostic criteria for symptomatic multiple myeloma 3. Subject is eligible for and plans to undergo ASCT 4. History of Grade = 3 infusion-associated AEs or hypersensitivity to another monoclonal antibody, or known hypersensitivity to diphenhydramine or acetaminophen |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Eastern Health (Box Hill Hospital) | Box Hill | |
| Australia | Amyloidosis Clinic Cnr Darcy Road and Bridge St. Westmead | Sydney | |
| Australia | The University of Queensland-Princess Alexandra Hospital (PAH) | Woolloongabba | |
| Austria | Universitatsklinik fur Innere Medizin 1 Kinische Abteilung fur Onkologie Aligemeines Krankenhaus - Universitatskliniken | Wien | |
| Belgium | ZNA Stuivenberg | Antwerpen | |
| Belgium | ULB Hopital Erasme | Brussel | |
| Belgium | UZ Gasthuisberg | Leuven | |
| Canada | University of Calgary-Southern Alberta Cancer Research Institute | Calgary | Alberta |
| Canada | Cross Cancer Institute | Edmonton | Alberta |
| Canada | Jewish General Hospital | Montreal | Quebec |
| Canada | Princess Margaret Cancer Research Centre | Toronto | Ontario |
| Denmark | Rigshospitalet | Copenhagen | |
| France | Hopital de la Cote de Nacre Avenue | Caen Cedex 9 | |
| France | Hopital Henri Mondor | Creteil | |
| France | CHU Dijon - Hopital du Bocage | Dijon | |
| France | Hôpital Dupuytren - CHU Limoges | Limoges | |
| France | Hôpital Pitié-Salpêtrière | Paris | |
| France | Hopitaux Lyon Sud | Pierre-Benite Cedex | |
| France | Service d'Hermatologie CHU de Poitiers | Poitiers | |
| France | CHU Rennes, Service de Medecine Interne | Rennes Cedex 2 | |
| Germany | Charite-Universitatsmedizin | Berlin | |
| Germany | Universitätsklinikum Essen | Essen | |
| Germany | Universitatsklinikum Hamburg-Eppendorf (UKE) | Hamburg | |
| Germany | Universitatsklinikum Heidelberg | Heidelberg | |
| Greece | Alexandra General Hospital of Athens | Athens | |
| Greece | University Hospital of Patras | Patra | |
| Israel | Hadassah University Medical Center | Jerusalem | |
| Israel | Meir Medical Center | Kfar Saba | |
| Israel | The Chaim Sheba Medical Center | Ramat Gan | |
| Israel | Tel Aviv Sourasky Medical Center | Tel Aviv | |
| Italy | Policlinico S.Orsola Malpighi, Unita' Operativa di Ematologia | Bologna | |
| Italy | Policlinica San Matteo | Pavia | |
| Italy | Azienda Ospedaliera Sant'Andrea, U.O.S. | Rome | |
| Netherlands | University Medical Center Groningen | Groningen | |
| Netherlands | Universitair Medisch Centrum Utrecht | Utrecht | |
| Poland | MTZ Clinical Research Sp. z o.o. | Warszawa | |
| Spain | Hospital Universitari Germans Trias i Pujol | Badalona | |
| Spain | Hospital Clinic de Barcelona | Barcelona | |
| Spain | Hospital Universitario 12 de Octubre | Madrid | |
| Spain | Hospital Universitario Puerta de Hierro - Maiadahonda | Madrid | |
| Spain | Clínica Universidad de Navarra | Pamplona | Nevarra |
| United Kingdom | University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital | Birmingham | |
| United Kingdom | University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre | Bristol | |
| United Kingdom | Leicester Royal Infirmary | Leicester | |
| United Kingdom | The Royal Free London NHS Foundation Trust-The Royal Free Hospital | London | |
| United Kingdom | NNUH NHS Foundation Trust - Norfolk and Norwich University Hospital | Norwich | |
| United Kingdom | Southampton General Hospital | Southampton | |
| United States | Winship Cancer Institute of Emory University | Atlanta | Georgia |
| United States | John Hopkins University School of Medicine | Baltimore | Maryland |
| United States | Boston University School of Medicine | Boston | Massachusetts |
| United States | Tufts Medical Center | Boston | Massachusetts |
| United States | University of North Carolina Chapel Hill Comprehensive Cancer Center | Chapel Hill | North Carolina |
| United States | Levine Cancer Institute | Charlotte | North Carolina |
| United States | Radiant Research Northwestern University | Chicago | Illinois |
| United States | University of Chicago Medicine | Chicago | Illinois |
| United States | The Cleveland Clinic - Main Campus | Cleveland | Ohio |
| United States | Colorado Blood Cancer Institute | Denver | Colorado |
| United States | Karmanos Cancer Institute | Detroit | Michigan |
| United States | City of Hope | Duarte | California |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | University of Texas; MD Anderson Cancer Center | Houston | Texas |
| United States | Indiana University Cancer Center | Indianapolis | Indiana |
| United States | Mayo Clinic | Jacksonville | Florida |
| United States | Sylvester Cancer Center, University of Miami | Miami | Florida |
| United States | Froedtert & Medical College of Wisconsin, Cancer Center-Froedtert Hospital | Milwaukee | Wisconsin |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
| United States | Columbia University - College of Physicians & Surgeons | New York | New York |
| United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
| United States | Newark Beth Israel Medical Center | Newark | New Jersey |
| United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | University of Pittsburg - Hillman Cancer Center | Pittsburgh | Pennsylvania |
| United States | Oregon Health & Science University | Portland | Oregon |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Washington University in Saint Louis | Saint Louis | Missouri |
| United States | Huntsman Cancer Institute | Salt Lake City | Utah |
| United States | Mayo Clinic Arizona | Scottsdale | Arizona |
| United States | University of Washington | Seattle | Washington |
| United States | Stanford Cancer Institute (SCI) | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| Prothena Biosciences Ltd. |
United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, Italy, Netherlands, Poland, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to Composite of All-cause Mortality or Cardiac Hospitalization | Time to all-cause mortality death occurring after the first infusion of study drug or cardiac hospitalization as adjudicated by the CEC occurring at least 91 days after first infusion of study drug through last subject last visit, whichever came first | Randomization until the date of death or cardiac hospitalization, up to 32 months |