RecruitingNCT06212323

Smoldering Myeloma High-Risk Patient Observation and Longitudinal Insight Trial


Sponsor

University of Utah

Enrollment

100 participants

Start Date

Jan 11, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an observational study (not a treatment trial) for people with high-risk smoldering multiple myeloma — a precursor condition to multiple myeloma (a type of blood cancer) that has not yet caused symptoms or organ damage. Researchers want to learn more about how this condition progresses over time by carefully following patients and collecting data. **You may be eligible if...** - You are 18 or older - You have been diagnosed with smoldering multiple myeloma (a pre-cancer blood condition) according to established medical criteria - Your condition is classified as high-risk based on specific markers in your blood and bone marrow - Your high-risk diagnosis was made within the past 12 months - You are willing to participate in long-term follow-up visits **You may NOT be eligible if...** - Your condition has already progressed to active multiple myeloma (with symptoms or organ damage) - You have plasma cell tumors outside the bone marrow - You have any focal bone lesions or areas of bone destruction on imaging - You have already started treatment for multiple myeloma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPatients 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.


Locations(1)

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, United States

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NCT06212323


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