Smoldering Myeloma High-Risk Patient Observation and Longitudinal Insight Trial
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.
• 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/intermediate SMM- the date at which high-risk SMM was diagnosed would have to be within 365 days of enrollment in the study.