Smoldering Myeloma High-Risk Patient Observation and Longitudinal Insight Trial
ConditionSmoldering Multiple Myeloma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Utah
About this 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.
Eligibility criteria
Qualifiers
Adult subject aged ≥ 18 years.
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
M-spike greater than 2 g/dL
Disqualifiers
Presence of any features that would meet diagnostic criteria for myeloma as per the IMWG Criteria
Presence of extramedullary plasmacytomas
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.
Trial design
Treatments tested in this trial
- Patients with smoldering myeloma undergoing active surveillance with diffusion weighted whole body MRI.
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov