Actively Recruiting
Smoldering Myeloma High-Risk Patient Observation and Longitudinal Insight Trial
Led by University of Utah · Updated on 2026-02-17
100
Participants Needed
1
Research Sites
320 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Smoldering Myeloma High-Risk Patient Observation and Longitudinal Insight Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of smoldering myeloma per IMWG criteria with serum monoclonal protein (IgG or IgA) 30g/L per 24 hours or urinary monoclonal protein 500mg per 24 hours and/or clonal bone marrow plasma cells 10-59% without myeloma-defining events or amyloidosis
- High-risk smoldering myeloma defined by two or more of the following: M-spike > 2 g/dL; involved/uninvolved free light chain ratio > 20; bone marrow plasmacytosis > 20%; presence of specified cytogenetic abnormalities; or IMWG SMM score 9 or greater
- Diagnosis of high-risk smoldering myeloma made within 365 days of enrollment
You will not qualify if you...
- Presence of features meeting diagnostic criteria for myeloma per IMWG criteria
- Presence of extramedullary plasmacytomas
- Presence of any focal bone marrow lesions or lytic bone lesions on imaging before or at screening (except diffuse or patchy marrow infiltration without clear lesions)
- Presence of one focal marrow lesion due to plasma cell dyscrasia unless deemed unrelated by investigator
- Creatinine clearance less than 40 ml/min
- Presence of AL Amyloidosis
- Patients who previously met 2/4 high-risk criteria but do not currently meet at least 2/4 of the 2/20/20 criteria at enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
S
Sharmilee Nuli
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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