Phase
Condition
Cancer/tumors
Bone Neoplasm
Leukemia
Treatment
Linvoseltamab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Confirmed diagnosis of symptomatic multiple myeloma (MM) by International MyelomaWorking Group (IMWG) diagnosis criteria
Measurable disease, according to the 2016 IMWG response criteria, as defined in theprotocol
No prior therapy for MM, with the exception of prior emergent or palliativeradiation and up to 1 month of single-agent corticosteroids, with washout periods asper the protocol
Participants must have evidence of adequate bone marrow reserves and hepatic, renaland cardiac function as defined in the protocol
Participants must be age <70 and have adequate hepatic, renal, pulmonary and cardiacfunction to be considered transplant-eligible. The specific thresholds for adequateorgan function are as per institutional guidance.
Exclusion
Key Exclusion Criteria:
Receiving any concurrent investigational agent with known or suspected activityagainst MM, or agents targeting the A proliferation-inducing ligand (APRIL)/Transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI)/BCMA axis
Known central nervous system (CNS) involvement with MM, known or suspectedprogressive multifocal leukoencephalopathy (PML), a history of neurocognitiveconditions, or CNS movement disorder, or history of seizure within 12 months priorto study enrollment
Rapidly progressive symptomatic disease, (e.g. progressing renal failure orhypercalcemia not responsive to standard medical interventions), in urgent need oftreatment with chemotherapy
Diagnosis of non-secretory MM, active plasma cell leukemia, primary light-chain (AL)amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or knownPOEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly,endocrinopathy, monoclonal protein, and skin changes)
Note: Other protocol-defined Inclusion/Exclusion criteria apply
Study Design
Connect with a study center
Gustave Roussy
Villejuif, Ile De France 94800
FranceActive - Recruiting
Hopital Necker
Paris, Ile-de-France 75015
FranceActive - Recruiting
Hopital Necker / Necker Hospital
Paris, Ile-de-France 75015
FranceActive - Recruiting
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, Nouvelle-Aquitaine 86021
FranceActive - Recruiting
Hospital Saint-Louis - APHP
Paris, Île-de-France 75010
FranceActive - Recruiting
CHU De Lille
Lille, 59000
FranceSite Not Available
CHU Montpellier
Montpellier, 342950
FranceActive - Recruiting
Centre Hospitalier Universitaire (CHU) Montpellier
Montpellier, 342950
FranceActive - Recruiting
Hopital Pitié Salpetriere APHP
Paris, 75013
FranceActive - Recruiting
Hopital Saint Louis
Paris, 75010
FranceActive - Recruiting
Hopital Universitaire Necker Enfants Malades
Paris, 75015
FranceActive - Recruiting
Hospital Universitario Central De Asturias
Oviedo, Asturias 33011
SpainActive - Recruiting
Hospital Germans Trias i Pujol
Badalona, Barcelona 08916
SpainActive - Recruiting
Hospital General Universitario Doctor Balmis Alicante
Alicante, Comunidad Valenciana 03010
SpainActive - Recruiting
Hospital Universitario Quiron Salud Madrid
Pozuelo de Alarcon, Madrid 28223
SpainActive - Recruiting
Clinica Universidad de Navarra
Pamplona, Navarra 31008
SpainActive - Recruiting
Clinica Universidad de Navarra
Madrid, San Blas-Canillejas, Madrid, 28027
SpainActive - Recruiting
Hospital Universitario Politecnico La Fe
Valencia, València 46026
SpainActive - Recruiting
Hospital General Universitario de Alicante
Alicante, 03010
SpainSite Not Available
Hospital Clinic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Institut Catala dOncologia (ICO Hospitalet)
Barcelona, 08908
SpainActive - Recruiting
Clinica Universidad de Navarra - Madrid
Madrid, 28027
SpainActive - Recruiting
Hospital Universitario Quironsalud Madrid
Madrid, 28223
SpainActive - Recruiting
Universitary Hospital La Princesa
Madrid, 28006
SpainActive - Recruiting
Hospital Universitario de Salamanca
Salamanca, 37007
SpainActive - Recruiting
Instituto de Investigación Biomédica de Salamanca
Salamanca, 37007
SpainSite Not Available
La Fe University Hospital
Valencia, 46026
SpainActive - Recruiting
UCLA
Los Angeles, California 90095
United StatesActive - Recruiting
University of California
Los Angeles, California 90095
United StatesActive - Recruiting
University of California Los Angeles (UCLA)
Los Angeles, California 90095
United StatesActive - Recruiting
UC Irvine Health
Orange, California 92868
United StatesActive - Recruiting
UCI Health
Orange, California 92868
United StatesActive - Recruiting
Colorado Blood Cancer Institute
Denver, Colorado 80218
United StatesSite Not Available
Colorado Blood Cancer Institute/SCRI
Denver, Colorado 80218
United StatesActive - Recruiting
Colorado Blood Cancer Instiute/SCRI
Denver, Colorado 80218
United StatesActive - Recruiting
Norton Cancer Institute
Louisville, Kentucky 40207
United StatesActive - Recruiting
Norton Healthcare, Inc.
Louisville, Kentucky 40202
United StatesSite Not Available
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York 11501
United StatesActive - Recruiting
Columbia University Medical Center
New York, New York 10032
United StatesActive - Recruiting
NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
Perlmutter Cancer Center
New York, New York 10016
United StatesActive - Recruiting
Stony Brook University Hospital
Stony Brook, New York 11794
United StatesActive - Recruiting
Atrium Health Levine Cancer
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Levine Cancer Institute
Charlotte, North Carolina 28204
United StatesActive - Recruiting
MD Anderson Cancer Centre
Houston, Texas 77030
United StatesActive - Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
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