Observes high-risk smoldering myeloma patients with whole body MRI scans over time
Follows adults with high-risk smoldering myeloma under close monitoring with whole body MRI.
Plain-language title generated from the registry record
Registry title: Smoldering Myeloma High-Risk Patient Observation and Longitudinal Insight Trial
Key facts
- Where
- Salt Lake City, United StatesSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with high-risk smoldering myeloma, diagnosed within the last 365 days, who are followed closely with whole body MRI scans.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Smoldering myeloma as defined by the IMWG criteria, at high risk (two or more of four risk features, or an IMWG SMM score of 9 or greater). High-risk smoldering myeloma must have been diagnosed within 365 days before joining.
- Biomarker or test result
- High-risk features include a serum M-spike greater than 2 g/dL, a free light chain ratio greater than 20, bone marrow plasma cells greater than 20%, or certain gene changes: translocation (4;14), deletion 17p, deletion 13q or 1q gain.
Main reasons for not taking part
- Signs that meet the IMWG criteria for myeloma
- Extramedullary plasmacytomas
- Focal bone marrow lesions or lytic bone lesions on imaging, unless a single lesion is judged unrelated to myeloma
- Creatinine clearance of less than 40ml/min
- AL amyloidosis
Read by machine on 9 November 2026.
Where in United States
- Huntsman Cancer Institute at the University of UtahSalt Lake City, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Utah
- Trial code
- NCT06212323
- Record updated
- 17 February 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Presence of any focal bone marrow lesions, or lytic bone lesions on imaging done prior to screening or on screening. However, presence of diffuse or patchy infiltration of the marrow (without any clear lesions) on MRI, will not be an exclusion criteria. Patients with 1 focal marrow lesion on MRI that is attributable to plasma cell dyscrasia, will be excluded from study, even if they do not meet criteria for myeloma. Patients with 1 focal marrow lesion can only be enrolled if the lesion does not appear to be related to myeloma, based on the judgement of the investigator. Use of restricted diffusion and ADC values can assist in ascertainment; 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; Presence of any features that would meet diagnostic criteria for myeloma as per the IMWG Criteria; Presence of extramedullary plasmacytomas.