Smoldering Myeloma High-Risk Patient Observation and Longitudinal Insight Trial
University of Utah
100 participants
Jan 11, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria11
- 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.
Exclusion Criteria6
- Presence of any features that would meet diagnostic criteria for myeloma as per the IMWG Criteria
- Presence of extramedullary plasmacytomas
- Creatinine clearance of less than 40ml/min.
- Presence of AL Amyloidosis (the amount of workup necessary to exclude AL Amyloidosis is per the discretion of the treating investigator, however the investigator must attest that they do not believe AL Amyloidosis to be present at time of enrollment. Serum nt-PROBNP is recommended as part of evaluation in order to ascertain for cardiac amyloidosis).
- Note: The Hgb cut-offs can vary between institutions (lower cut-off for Hgb University of Utah for men is a Hgb of 14.8, rendering a patient with Hgb of 12.7 as having a CRAB feature). If the Hgb is above 10g/dl but the patient meets the definition of anemia according to the IMWG criteria, by virtue of this being more than 2 g/dl below the limit of normal, the investigator can decide whether to call a patient being considered for screening as having multiple myeloma OR smoldering myeloma and allow enrollment on this study.
- Given that the values used to define high-risk SMM can change, at time of enrollment, if utilizing at least 2/4 of the 2/20/20+cytogenetics criteria to enroll, participants should meet at least 2/4 of the 2/20/20. If participants had met at least 2/4 previously at some timepoint but do not meet at least 2/4 currently, they cannot be enrolled in the study.
Interventions
Patients with high-risk smoldering myeloma will be prospectively followed and chart review will be performed to determine if progression events happen, and how they happen. All patients on the study are recommended to undergo the following standard of care surveillance protocol: * Complete Blood Count (CBC), Complete Metabolic Panel (CMP), myeloma blood tests (serum kappa/lambda light chains, monoclonal protein evaluation, immunoglobulin levels), to be done monthly for first year, and then every two months for the second year. * WB DW-MRIs every 6 months during the study period. * 24-hour urine Immunofixation/electrophoresis is expected to be completed approximately every 6 months. * Bone marrow biopsy will be performed annually during the study time-period.
Locations(1)
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NCT06212323