Spots Global Cancer Trial Database for Study in Subjects With Light Chain (AL) Amyloidosis
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Trial Identification
Brief Title: Study in Subjects With Light Chain (AL) Amyloidosis
Official Title: A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects With Light Chain (AL) Amyloidosis Who Were Previously Enrolled in Study NEOD001-201 (PRONTO)
Study ID: NCT03154047
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: Global, multicenter, Phase 2b, open-label extension study of subjects with AL amyloidosis who had a hematologic response to first-line treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant \[ASCT\]) and completed Study NEOD001-201. Subjects in this study may receive concomitant chemotherapy. Subject screening will occur during the 28 days prior to the first administration of study drug, which may overlap with the last visit in Study NEOD001-201. If all eligibility requirements are met, the subject will be enrolled and Screening assessments will be completed. Study visits will occur every 28 days based on scheduling from Month 1 Day 1. A ±5-day window is allowed for visits starting after Month 1. Subjects who discontinue study drug before the End of Study Visit (EOS) should have an Early Treatment Discontinuation Visit 30 (±5) days after their final administration of study drug. Each subject's study participation may be up to 38 months or until the study is terminated, whichever occurs first. The study consists of a Screening Phase (1 month), Treatment Phase (36 months), and EOS Visit (30 \[±5\] days after the last dose).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
Mayo Clinic Hospital - Florida, Jacksonville, Florida, United States
University of Chicago Medicine, Chicago, Illinois, United States
Indiana University Simon Cancer Center, Indianapolis, Indiana, United States
Tufts Medical Center, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Mayo Clinic - Minnesota, Rochester, Minnesota, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Westmead Hospital, Sydney, New South Wales, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Eastern Health (Box Hill Hospital), Box Hill, Victoria, Australia
Medizinische Universität Wien, Vienna, , Austria
Hôpital Dupuytren - CHU Limoges, Limoges, , France
Hôpital Pitié-Salpêtrière, Paris, , France
Charité - Universitätsmedizin Berlin, Berlin, , Germany
University of Duisburg-Essen, Essen, , Germany
Universitätsklinikum Hamburg-Eppendorf (UKE), Hamburg, , Germany
Universitätsklinikum Heidelberg, Heidelberg, , Germany
Alexandra General Hospital of Athens, Athens, , Greece
University Hospital of Patras, Patras, , Greece
Hadassah Medical Center (HMC), Jerusalem, , Israel
Fondazione IRCCS Policlinico San Matteo, Pavia, , Italy
Hospital Clínic de Barcelona, Barcelona, , Spain
Hospital Universitario Puerta de Hierro - Majadahonda, Majadahonda, , Spain
Queen Elizabeth Hospital, Birmingham, England, United Kingdom
The Royal Free Hospital, London, England, United Kingdom
Contact Details
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