Smoldering Myeloma High-Risk Patient Observation and Longitudinal Insight Trial

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT06212323
Status
Recruiting
Apply to this trial

Conditions

  • Smoldering Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Patients with smoldering myeloma undergoing active surveillance with diffusion weighted whole body MRI. — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jan 11, 2024
Status verified
Feb 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2030

Study Design

Enrollment
100 participants (estimated)

Primary Outcome Measure

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. [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer Institute at the University of UtahSalt Lake CityUtah84112
Bailee Daniels
[email protected]
801-587-4699

Find similar trials in Salt Lake City, UT

By research site
Huntsman Cancer Institute at the University of Utah· Salt Lake City, UT

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