Smoldering Myeloma High-Risk Patient Observation and Longitudinal Insight Trial
Trial Parameters
Brief Summary
The purpose of this study is to define the natural history of high-risk smoldering myeloma in a modern cohort of patients undergoing close standard of care follow-up with diffusion weighted whole body magnetic resonance imaging.
Eligibility Criteria
Inclusion Criteria: * Adult subject aged ≥ 18 years. * Diagnosis of smoldering myeloma as per the IMWG criteria, specifically: * Serum monoclonal protein (IgG or IgA) of 30g/L or greater per 24 hours or urinary monoclonal protein of 500mg or greater per 24 hours and/or * Clonal bone marrow plasma cells 10-59% with the absence of myeloma-defining events or amyloidosis * High-risk smoldering myeloma defined as two or more out of four of the following criteria: * M-spike greater than 2 g/dL * An involved/uninvolved free light chain ratio greater than 20 * Bone marrow plasmacytosis greater than 20% * Presence of any of translocation (4;14), deletion 17p, deletion 13q or 1q gain by conventional cytogenetics/fluorescence in situ hybridization (FISH) studies) and/or * An IMWG SMM score of 9 or greater according to the IMWG risk model for smoldering multiple myeloma (SMM) * Diagnosis of high-risk SMM made within 365 days of enrollment in the study. Note: If a patient previously had MGUS or low