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