Home › Smoldering Multiple Myeloma › NCT06365060
Screening for AL Amyloidosis in Smoldering Multiple Myeloma
RecruitingObservational study
Who can join
Ages 40 and older · All sexes
Full 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
About the study
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.
Sponsor: Tufts Medical Center · Participants: 400 · Started: May 1, 2024
Contact the study team
- Raymond Comenzo, MD · Phone: 617-636-6454
- Denis Toskic, BS · Phone: 617-636-5907
Official record on ClinicalTrials.gov — NCT06365060
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.