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Observational Study for High-Risk Smoldering Myeloma

This study is for people with high-risk smoldering multiple myeloma, a condition that can sometimes turn into active multiple myeloma. It's an observational study, meaning researchers will follow participants closely to understand how the condition naturally progresses. You would undergo standard care, including regular check-ups and a special type of MRI called diffusion-weighted whole-body MRI. The main goal is to see how often serious health problems related to plasma cell disorders (like kidney damage or bone fractures) occur within two years. Researchers will also review your medical records to track these events. The study aims to enroll 100 participants aged 18 or older who meet specific diagnostic criteria for high-risk smoldering myeloma.

Study design
This is an observational study with a planned enrollment of 100 participants. It is designed to follow patients with high-risk smoldering myeloma over time.
What's involved
You would undergo active surveillance with diffusion-weighted whole-body MRI and standard of care surveillance protocols. Researchers will also perform chart reviews.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to observe the incidence of morbid progression events at two years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06212323

Smoldering Myeloma High-Risk Patient Observation and Longitudinal Insight Trial

Recruiting
Not specifiedAges 18+Observational
University of Utah
~100 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:Patients with smoldering myeloma undergoing active surveillance with diffusion weighted whole body MRI.

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of morbid progression events attributable to a plasma cell dyscrasia at two years, with morbid events defined as: death, renal injury that does not reverse, fracture, lytic bone lesion, AL Amyloidosis or plasma cell leukemia.
Measured over 2 years

Conditions

Smoldering Multiple Myeloma

Explore related trials

Smoldering Multiple MyelomaBone marrow plasma cellsCytogeneticsFLC ratioIMWG SMM scoreM-spike

Where it's being run

1 sites across 1 states
Utah1

Study leadership

  • Ghulam Rehman Mohyuddin, MD · PRINCIPAL_INVESTIGATOR · Huntsman Cancer Institute

Who to contact

Sharmilee Nuli
[email protected]
801-585-0255
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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 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).

What this trial measures

  • Incidence of morbid progression events attributable to a plasma cell dyscrasia at two years, with morbid events defined as: death, renal injury that does not reverse, fracture, lytic bone lesion, AL Amyloidosis or plasma cell leukemia.2 years

    Frequency and nature of progression events in a prospective cohort of patients with smoldering myeloma undergoing active surveillance with diffusion weighted whole body MRI