Phase
Condition
Multiple Myeloma
Cancer/tumors
Bone Neoplasm
Treatment
Linvoseltamab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
KEY Inclusion Criteria:
High-risk SMM diagnosis within 5 years of study enrollment
Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Adequate hematologic and hepatic function, as described in the protocol
Estimated glomerular filtration rate ≥30 mL/min/1.73 m^2
Exclusion
KEY Exclusion Criteria:
- Evidence of myeloma defining events *SLiM CRAB, as described in the protocol
*SLiM (greater than or equal to Sixty percent clonal plasma cells in the bonemarrow, involved/uninvolved free Light chain ratio of ≥100 with the involved freelight chain (FLC) being ≥100 mg/L, MRI with >1 focal lesion) CRAB (hyperCalcemia,Renal insufficiency, Anemia, or lytic Bone lesions)
Diagnosis of systemic light chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), soft tissue plasmacytoma, or symptomatic multiplemyeloma
Clinically significant cardiac or vascular disease within 3 months of studyenrollment, as described in the protocol
Any infection requiring hospitalization or treatment with IV anti-infectives within 28 days of first dose of study drug
Uncontrolled human immunodeficiency virus (HIV), hepatitis B virus (HBV), orhepatitis C virus (HCV) infection; or other uncontrolled infection or unexplainedsigns of infection
History of severe allergic reaction attributed to compounds with a similar chemicalor biologic composition as the study drug or excipient
NOTE: Other protocol defined inclusion/exclusion criteria apply
Study Design
Connect with a study center
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, A Coruna 15706
SpainActive - Recruiting
Hospital Universitario Virgen de las Nieves
Granada, Andalusia 18014
SpainActive - Recruiting
University Hospital of Cabuenes
Gijon, Asturias 33203
SpainActive - Recruiting
Hospital Universitari Son Llatzer
Palma Mallorca, Baleares 07198
SpainActive - Recruiting
Hospital Germans Trias i Pujol
Badalona, Barcelona 08916
SpainActive - Recruiting
Hospital Universitario Marques de Valdecilla
Santander, Cantabria 39008
SpainActive - Recruiting
Hospital Universitario Quiron Salud Madrid
Pozuelo de Alarcon, Madrid 28223
SpainActive - Recruiting
Hospital Universitario Quiron Salud Madrid
Pozuelo de Alarcón, Madrid 28223
SpainSite Not Available
Hospital Clinico Universitario Virgen De La Arrixaca
El Palmar, Murcia 30120
SpainActive - Recruiting
Clinica Universidad de Navarra
Pamplona, Navarra 31008
SpainActive - Recruiting
Clinica Universidad de Navarra - Paploma
Pamplona, Navarra 31008
SpainActive - Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Institut Catala d'Oncologia
Barcelona, 08908
SpainActive - Recruiting
Clinica Universidad de Navarra - Madrid
Madrid, 28027
SpainActive - Recruiting
Hospital General Universitario Gregorio Maranon
Madrid, 28009
SpainActive - Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
SpainActive - Recruiting
Hospital Clinico Universitario de Salamanca
Salamanca, 37007
SpainActive - Recruiting
Hospital Universitario de Salamanca
Salamanca, 37007
SpainActive - Recruiting
La Fe University Hospital
Valencia, 46026
SpainActive - Recruiting
University Hospital Doctor Peset
Valencia, 46017
SpainActive - Recruiting
University Hospital La Fe
Valencia, 46026
SpainActive - Recruiting
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