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Screening for AL Amyloidosis in Smoldering Multiple Myeloma

RECRUITINGSponsored by Tufts Medical Center
Actively Recruiting
SponsorTufts Medical Center
Started2024-05-01
Est. completion2029-02-27
Eligibility
Age40 Years+
Healthy vol.Accepted
Locations13 sites

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

Age: 40 Years+Healthy volunteers accepted
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

Conditions2

CancerSmoldering Multiple Myeloma

Locations13 sites

University of Alabama Hospital
Birmingham, Alabama, 35233
Megan Maier205-882-1041mmaier@uabmc.edu
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Robert Vescio, MD
University of California, San Francisco
San Francisco, California, 94143
Jane Greenaway415-269-8259jane.greenaway@ucsf.edu
Cleveland Clinic Florida, Weston Hospital
Weston, Florida, 33331
Chakra Chaulagain, MD
Tufts Medical Center
Boston, Massachusetts, 02111
Denis Toskic617-636-5907denis.toskic@tuftsmedicine.org

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