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 4347778, Maryland 4361885, United States
Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926, United States
Stony Brook University Hospital
Stony Brook 5139865, New York 5128638, United States
Thomas Jefferson University Hospital
Philadelphia 4560349, Pennsylvania 6254927, United States
University of Washington
Seattle 5809844, Washington 5815135, United States
Hospital Universitario Virgen de las Nieves
Granada 2517117, Andalusia 2593109, Spain
Hospital Universitari Mutua Terrassa
Terrassa 3108286, Barcelona, Spain
Hospital Clinico Universitario Virgen De La Arrixaca
El Palmar 2518294, Murcia 2513413, Spain
Hospital de Cabuenes
Gijón 3121424, Principality of Asturias 3114710, Spain
Hospital Sant Pau
Barcelona 3128760, Spain
Universitaru Hospital La Princesa
Madrid 3117735, Spain
Hospital General Universitario Morales Meseguer
Murcia 2513416, Spain
Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com
Clinical Trial Management, Study Director
Regeneron Pharmaceuticals