A Proof-of-Concept Trial to Study the Safety and Activity of Linvoseltamab in Adult Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma

Key Inclusion Criteria:

• High-risk SMM diagnosis within 5 years of study enrollment, as described in the protocol
• 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

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 bone marrow, involved/uninvolved free Light chain ratio of ≥100 with the involved free light 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 multiple myeloma
• Clinically significant cardiac or vascular disease within 3 months of study enrollment, as described in the protocol
• Any infection requiring hospitalization or treatment with intravenous anti-infectives within 28 days of first dose of study drug
• 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
• History of severe allergic reaction attributed to compounds with a similar chemical or biologic composition as the study drug or excipient

NOTE: Other protocol defined inclusion/exclusion criteria apply