Screening for AL Amyloidosis in Smoldering Multiple Myeloma

Recruiting now

Conditions studied: Smoldering Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT06365060

Run by

Tufts Medical Center

People needed

400

Starts

2024-05-01

Expected to finish

2029-02-27

Last updated by the study team

2025-08-06

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• VCU Medical Center — Richmond, Virginia, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• University of California, San Francisco — San Francisco, California, United States (enrolling)
• Cleveland Clinic Florida, Weston Hospital — Weston, Florida, United States (enrolling)
• Tufts Medical Center — Boston, Massachusetts, United States (enrolling)
• Columbia University Irving Medical Center — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Atrium Health Levine Cancer Institute — Charlotte, North Carolina, United States (enrolling)
• UNC Lineberger Comprehensive Cancer Center — Durham, North Carolina, United States (enrolling)
• The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (enrolling)
• University of Alabama Hospital — Birmingham, Alabama, United States (enrolling)
• University of Utah, Huntsman Cancer Hospital — Salt Lake City, Utah, United States (enrolling)
• UT Southwestern, Harold C. Simmons Comprehensive Cancer Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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