Phase
Condition
Cancer/tumors
Bone Neoplasm
Leukemia
Treatment
Linvoseltamab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Confirmed diagnosis of AL amyloidosis, as described in the protocol
Measurable disease as defined by serum difference between involved and uninvolvedfree light chains (dFLC) concentration, as described in the protocol
Previously treated after at least 1 prior therapy and requiring further treatment asassessed by the Investigator
N-terminal pro b-type natriuretic peptide (NT-proBNP) ≤8500 ng/L during screening
Adequate hepatic, hematologic, renal, and cardiac function, as described in theprotocol
Eastern Cooperative Oncology Group (ECOG) performance score ≤2 at screening
Exclusion
Key Exclusion Criteria:
History of other non-AL amyloidosis
Greater than 60% plasmacytosis on a bone marrow biopsy and/or aspirate duringscreening
Presence of lytic bone lesion(s) or extramedullary plasmacytoma on imaging duringscreening
Myocardial infarction within the past 6 months prior to the first screening visit
Known active infection requiring hospitalization or treatment with IVanti-infectives within 28 days of first administration of study drug
NOTE: Other protocol defined inclusion/exclusion criteria apply
Study Design
Connect with a study center
Asan Medical Center
Seoul, 05505
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Seoul St. Mary's Hospital - The Catholic University of Korea
Seoul, 065791
Korea, Republic ofActive - Recruiting
Asan Medical Center
Seoul 1835848, 05505
South KoreaActive - Recruiting
Samsung Medical Center
Seoul 1835848, 06351
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul 1835848, 03080
South KoreaActive - Recruiting
Seoul St. Mary's Hospital - The Catholic University of Korea
Seoul 1835848, 065791
South KoreaActive - Recruiting
Hospital de Cabuenes
Gijon, Asturias 33203
SpainSite Not Available
Hospital Universitari Son Espases
Palma, Balearic Islands 07120
SpainSite Not Available
Universitary Hospital Son Espases
Palma, Balearic Islands 07120
SpainActive - Recruiting
University Hospital Son Espases
Palma, Balearic Islands 07120
SpainActive - Recruiting
Hospital Universitari Son Espases
Palma 2512989, Balearic Islands 2521383 07120
SpainActive - Recruiting
Clinica Universidad de Navarra
Pamplona, Navarra 31008
SpainSite Not Available
Clinica Universidad de Navarra - Pamplona
Pamplona 3114472, Navarre 3115609 31008
SpainActive - Recruiting
Hospital de Cabuenes
Gijón 3121424, Principality of Asturias 3114710 33203
SpainActive - Recruiting
Universität de Barcelona- Institut d' Investigacions Biomediques August Pi i Sunyer (IDIBAPS)
Barcelona, 08036
SpainSite Not Available
Universität de Barcelona- Institut d' Investigacions Biomediques August Pi i Sunyer (IDIBAPS)
Barcelona 3128760, 08036
SpainActive - Recruiting
University Hospital La Fe
Valencia, 46026
SpainSite Not Available
University Hospital La Fe
Valencia 2509954, 46026
SpainActive - Recruiting
University College London Hospitals
London, NW1 2PG
United KingdomSite Not Available
University College London Hospitals
London 2643743, NW1 2PG
United KingdomActive - Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BQ
United KingdomSite Not Available
The Christie NHS Foundation Trust
Manchester 2643123, M20 4BQ
United KingdomActive - Recruiting
City of Hope
Duarte, California 91010
United StatesSite Not Available
City of Hope
Duarte 5344147, California 5332921 91010
United StatesActive - Recruiting
Colorado Blood Cancer Institute/SCRI
Denver, Colorado 80218
United StatesSite Not Available
Colorado Blood Cancer Institute/SCRI
Denver 5419384, Colorado 5417618 80218
United StatesActive - Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201
United StatesActive - Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York 14263
United StatesSite Not Available
Roswell Park Comprehensive Cancer Center
Buffalo 5110629, New York 5128638 14263
United StatesActive - Recruiting
Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
Ohio State University
Columbus 4509177, Ohio 5165418 43210
United StatesActive - Recruiting
SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203
United StatesActive - Recruiting
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting

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