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).
The 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.
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).
HR-MGUS or NHR-SMM as defined 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 (GFR) ≥30 mL/min/1.73 m² by the Modification of Diet in Renal Disease (MDRD) equation
High-risk SMM, as defined in the protocol
Evidence of any of myeloma-defining events, as described in the protocol
Diagnosis of systemic light-chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), solitary plasmacytoma, or symptomatic MM
Clinically significant cardiac or vascular disease within 3 months of study enrollment, as described in the protocol
Sequential
Linvoseltamab
DrugAdministered per the protocol
Frequency of Adverse Events Interest (AEI) during the safety observation period
Part 1 An AEI is a toxicity potentially related to study treatment that may preclude dose escalation or expansion according to the Bayesian Optimal Interval (BOIN) design decision rules
Frequency of Treatment-Emergent Adverse Event (TEAEs) during the safety observation period
Part 1 As assessed by the NCI-CTCAE grading system version 5 (for all grades)
Severity of TEAEs during the safety observation period
Part 1 As assessed by the NCI-CTCAE grading system version 5 (for all grades)
Achievement of Complete Response (CR) as determined by the investigator
Part 2
Frequency of TEAEs
As assessed by the NCI-CTCAE grading system version 5 (for all grades)
Severity of TEAEs
As assessed by the NCI-CTCAE grading system version 5 (for all grades)
Frequency of Serious Adverse Events (SAEs)
Severity of SAEs
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