This study is researching an investigational drug called linvoseltamab ("study drug") inparticipants at moderate risk of developing multiple myeloma (about 3 to 10% averageannual risk), a group that consists of patients with precancerous conditions calledHigh-Risk Monoclonal Gammopathy of Undetermined Significance (HR-MGUS) and Non-High-RiskSmoldering Multiple Myeloma (NHR-SMM).The primary purpose of the study is to understand how well the study drug can eliminateabnormal plasma cells and laboratory signs of HR-MGUS and NHR-SMM.The study is looking at several other research questions, including: - How many participants treated with linvoseltamab have improvement of their HR-MGUS or NHR-SMM? - What side effects may happen from taking the study drug? - How much study drug is in the blood at different times? - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects).
Not Provided
Drug: Linvoseltamab
Administered per the protocol
Other Name: REGN5458,Lynozyfic™
Key Inclusion Criteria:
1. HR-MGUS or NHR-SMM as defined in the protocol
2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
3. Adequate hematologic and hepatic function, as described in the protocol
4. Estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73 m^2 by the Modification
of Diet in Renal Disease (MDRD) equation
Key Exclusion Criteria:
1. High-risk SMM, as defined in the protocol
2. Evidence of any of myeloma-defining events, as described in the protocol
3. Diagnosis of systemic light-chain amyloidosis, Waldenström macroglobulinemia
(lymphoplasmacytic lymphoma), solitary plasmacytoma, or symptomatic MM
4. Clinically significant cardiac or vascular disease within 3 months of study
enrollment, as described in the protocol
5. Any infection requiring hospitalization or treatment with intravenous (IV)
anti-infectives within 28 days of the first dose of linvoseltamab
6. Uncontrolled Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or
Hepatitis C Virus (HCV) infection; or other uncontrolled infection or unexplained
signs of infection, as described in the protocol
NOTE: Other protocol defined inclusion/exclusion criteria apply
Johns Hopkins Hospital
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Health
Ann Arbor, Michigan, United States
NYU Langone Health Perlmutter Cancer Center
New York, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Washington
Seattle, Washington, United States
Algemeen Ziekenhuis (AZ) Klina
Brasschaat, Antwerpen, Belgium
AZ St.-Elisabeth Herentals vzw
Herentals, Antwerp, Belgium
AZ Sint Maarten Algemeen Ziekenhuis Emmaus
Mechelen, Flanders, Belgium
Algemeen Ziekenhuis St Jan Brugge Oostende Av
Bruges, West-Vlaanderen, Belgium
Algemeen Ziekenhuis AZ Delta
Roeselare, West-Vlaanderen, Belgium
Ziekenhuis Netwerk Antwerpen Cadix, Hematology
Antwerp, Belgium
Centre Hospitalier Universitaire De Poitiers
Poitiers, New Aquitaine, France
Institut Curie
Paris, Île-de-France Region, France
Galway University Hospital
Galway, Connacht, Ireland
Cork University Hospital
Cork, Ireland
Mater Misericordiae University Hospital
Dublin, Ireland
Istituto Romagnolo per lo Studio Dei Tumori Dino Amadori
Meldola, Forli-Cesena, Italy
IRCCS Ospedale Policlinico San Martino
Genoa, Genova, Italy
San Paolo Hospital
Milan, Lombardy, Italy
Azienda Ospedaliero Universitaria (AOU) SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
UOC Ematologia e Terapia Cellulare - PO Mazzoni AST Ascoli Piceno
Ascoli Piceno, Italy
Universita degli Studi di Pavia - Fondazione IRCCS Policlini
Pavia, Italy
Ospedale Santa Maria delle Croci
Ravenna, Italy
Wojewodzki Szpital Zespolony - Ludwik Rydygier Provincial Hospital
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Specjalistyczny Szpital im A. Sokolowskiego w Walbrzychu
Wałbrzych, Lower Silesian Voivodeship, Poland
Pratia MCM Krakow
Krakow, Malopolska, Poland
University Clinical Center / Medical University of Gdansk
Gdansk, Pomeranian Voivodeship, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Mikolaja Kopernika w Lodzi (Copernicus Memorial Hospital)
Lodz, Poland
Swietokrzyskie Centrum Onkologii
Kielce, Świętokrzyskie Voivodeship, Poland
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, Spain
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, Spain
Hospital Clinico Universitario Virgen De La Arrixaca
El Palmar, Murcia, Spain
Hospital de Cabuenes
Gijón, Principality of Asturias, Spain
Hospital Sant Pau
Barcelona, Spain
Institut Catala dOncologia (ICO Hospitalet)
Barcelona, Spain
Universitaru Hospital La Princesa
Madrid, Spain
Hospital General Universitario Morales Meseguer
Murcia, Spain
Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com
Clinical Trial Management, Study Director
Regeneron Pharmaceuticals