RecruitingNCT06365060

Screening for AL Amyloidosis in Smoldering Multiple Myeloma

Sponsor

Tufts Medical Center

Enrollment

400 participants

Start Date

May 1, 2024

Study Type

OBSERVATIONAL

Conditions

Smoldering Multiple Myeloma

Summary

In this multicenter study, we will recruit 400 patients 40 years of age or older at 15 centers with a diagnosis of smoldering multiple myeloma (SMM), a group of patients for whom standard of care is observation not treatment. The main goal of this study is to screen for the diagnosis of light-chain amyloidosis (AL) before the onset of symptomatic disease and to develop a training set for a likelihood algorithm.

Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study screens patients with smoldering multiple myeloma (a precancerous blood condition) or a related condition (monoclonal gammopathy) for early signs of AL amyloidosis — a serious disease where abnormal proteins build up in organs and damage them. Early detection may allow earlier treatment. **You may be eligible if...** - You are 40 years old or older - You have been diagnosed with smoldering multiple myeloma or monoclonal gammopathy - Your blood test shows an elevated dFLC level (above 23 mg/L) with an abnormal free light chain ratio, OR you have reduced kidney function (eGFR below 50) and elevated dFLC **You may NOT be eligible if...** - You are under 40 years old - You have already had a biopsy showing amyloid deposits - You are pregnant, a minor, a prisoner, cognitively impaired, or otherwise unable to consent 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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Locations(13)

University of Alabama Hospital

Birmingham, Alabama, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

Cleveland Clinic Florida, Weston Hospital

Weston, Florida, United States

Tufts Medical Center

Boston, Massachusetts, United States

Columbia University Irving Medical Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Atrium Health Levine Cancer Institute

Charlotte, North Carolina, United States

UNC Lineberger Comprehensive Cancer Center

Durham, North Carolina, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

UT Southwestern, Harold C. Simmons Comprehensive Cancer Center

Dallas, Texas, United States

University of Utah, Huntsman Cancer Hospital

Salt Lake City, Utah, United States

VCU Medical Center

Richmond, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06365060

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