A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis)
Start Date
8/7/2024
Completion Date
2/20/2035
Summary
This study is researching an experimental drug called linvoseltamab ("study drug"). This study is focused on patients who have AL amyloidosis that has returned or have failed other therapies and need to be treated again. The study consists of 2 phases (Phase 1 and Phase 2): * In Phase 1, linvoseltamab will be given to a small number of participants to study the side effects of the study drug and to determine the recommended doses of the study drug to be given to participants in Phase 2. * In Phase 2, linvoseltamab will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of linvoseltamab to treat AL amyloidosis. The study is looking at several other research questions, including: * How many participants treated with linvoseltamab have improvement in the abnormal proteins that cause organ problems and for how long * How many participants treated with linvoseltamab have improvement in the heart or kidney and for how long * What the right dosing regimen is for linvoseltamab * What side effects may happen from taking linvoseltamab * How much linvoseltamab is in the blood at different times * Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects)
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Linvoseltamab
Conditions
Locations
City of Hope
Duarte, California 91010
United States
Colorado Blood Cancer Institute/SCRI
Denver, Colorado 80218
United States
Boston Medical Center
Boston, Massachusetts 02118
United States
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York 14263
United States
Ohio State University
Columbus, Ohio 43210
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
National and Kapodistrian University of Athens
Athens, 11528
Greece
Seoul National University Hospital
Seoul, 03080
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Seoul St. Mary's Hospital - The Catholic University of Korea
Seoul, 065791
South Korea
Hospital Universitari Son Espases
Palma, Balearic Islands 07120
Spain
Clinica Universidad de Navarra - Pamplona
Pamplona, Navarre 31008
Spain
Hospital de Cabuenes
Gijón, Principality of Asturias 33203
Spain
Universität de Barcelona- Institut d' Investigacions Biomediques August Pi i Sunyer (IDIBAPS)
Barcelona, 08036
Spain
University Hospital La Fe
Valencia, 46026
Spain
University College London Hospitals
London, NW1 2PG
United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BQ
United Kingdom