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Recruiting NCT06365060

Screening for AL Amyloidosis in Smoldering Multiple Myeloma

Conditions: Smoldering Multiple Myeloma

Sex: All
Ages: 40 Years – N/A
Healthy volunteers: No
Enrollment: 400
Sponsor: Tufts Medical Center

Location: University of Alabama Hospital Birmingham Alabama

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 Criteria

Inclusion Criteria: * Patients 40 years of age and older * diagnosed with either Smoldering Multiple Myeloma or a Monoclonal Gammopathy * dFLC greater than 23 mg/L * abnormal FLC ratio * If the patient has an eGFR less than 50 mL/min/1.73m2, the FLC ratio is inconsequential. The patient only needs to meet the age and dFLC criterion. Exclusion Criteria: * Patients younger than 40 years of age are not eligible * Patients with a previous finding of amyloid in other biopsies will not be included * Adults unable to consent are not eligible, including the cognitively impaired Pregnant women, pregnant minors, minors (i.e., individuals who are not yet adults), wards of the state, non-viable neonates, neonates of uncertain viability, and prisoners are not eligible

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06365060). StuddyBuddy aggregates publicly available trial information.