NCT06212323

Smoldering Myeloma High-Risk Patient Observation and Longitudinal Insight Trial

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Smoldering Multiple Myeloma

Interventions

Type	Name	Description
OTHER	Patients with smoldering myeloma undergoing active surveillance with diffusion weighted whole body MRI.	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.

Timeline

• Start date: 2024-01-11
• Primary completion: 2028-03-01
• Completion: 2030-03-01
• First posted: 2024-01-18
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States