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HR-MGUS or NHR-SMM as defined in the protocol\n2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1\n3. Adequate hematologic and hepatic function, as described in the protocol\n4. Estimated glomerular filtration rate (GFR) ≥30 mL\u002Fmin\u002F1.73 m\\^2 by the Modification of Diet in Renal Disease (MDRD) equation\n\nKey Exclusion Criteria:\n\n1. High-risk SMM, as defined in the protocol\n2. Evidence of any of myeloma-defining events, as described in the protocol\n3. Diagnosis of systemic light-chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), solitary plasmacytoma, or symptomatic MM\n4. Clinically significant cardiac or vascular disease within 3 months of study enrollment, as described in the protocol\n5. Any infection requiring hospitalization or treatment with intravenous (IV) anti-infectives within 28 days of the first dose of linvoseltamab\n6. 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\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria apply","ALL","18 Years",{"count":447,"type":448},116,"ESTIMATED","INTERVENTIONAL",[451],"PHASE2","This study is researching an investigational drug called linvoseltamab (\"study drug\") in participants at moderate risk of developing multiple myeloma (about 3 to 10% average annual risk), a group that consists of patients with precancerous conditions called High-Risk Monoclonal Gammopathy of Undetermined Significance (HR-MGUS) and Non-High-Risk Smoldering Multiple Myeloma (NHR-SMM).\n\nThe primary purpose of the study is to understand how well the study drug can eliminate abnormal plasma cells and laboratory signs of HR-MGUS and NHR-SMM.\n\nThe study is looking at several other research questions, including:\n\n* How many participants treated with linvoseltamab have improvement of their HR-MGUS or NHR-SMM?\n* What side effects may happen from taking the study drug?\n* How much study drug is in the blood at different times?\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects).",[454,455],"Monoclonal Gammopathy of Undetermined Significance (MGUS)","Smoldering Multiple Myeloma (SMM)",[457,458,459,460,461],"linvoseltamab","monoclonal immunoglobulin (M-protein)","cancer interception","immunotherapy","plasma cell disorders","2026-07-07",{"date":464,"type":465},"2026-07-08","ACTUAL",{"date":467,"type":465},"2024-09-16",{"date":469,"type":448},"2032-05-18",{"name":5,"class":6},39]