Screening for AL Amyloidosis in Smoldering Multiple Myeloma
ConditionSmoldering Multiple Myeloma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorTufts Medical Center
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Tufts Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov