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
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
Inclusion Criteria5
- 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 Criteria3
- 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
Locations(13)
View Full Details on ClinicalTrials.gov
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NCT06365060
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