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NCT06365060Recruiting

Screening for AL Amyloidosis in Smoldering Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
400 (estimated)
First submitted
10 Apr 2024
Start date
1 May 2024
Primary completion date
27 Feb 2029
Lead sponsor
Tufts Medical Center
NCT number
NCT06365060

What you commit to

  • Study type: Observational
  • Planned participants: 400
  • From 1 May 2024 to the primary completion date, 27 Feb 2029
  • 13 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with a previous finding of amyloid in other biopsies will not be included

Age

  • Patients younger than 40 years of age are not eligible

Other

  • 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

Who the study is looking for

  • 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.

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Alabama Hospital
Coordinator of this site? Confirm its status
BirminghamUnited StatesRecruiting
Tufts Medical Center
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BostonUnited StatesRecruiting
Atrium Health Levine Cancer Institute
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CharlotteUnited StatesRecruiting
The Ohio State University Comprehensive Cancer Center
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
UT Southwestern, Harold C. Simmons Comprehensive Cancer Center
Coordinator of this site? Confirm its status
DallasUnited StatesNot yet recruiting
UNC Lineberger Comprehensive Cancer Center
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DurhamUnited StatesRecruiting
Cedars-Sinai Medical Center
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Los AngelesUnited StatesRecruiting
Columbia University Irving Medical Center
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New YorkUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesRecruiting
VCU Medical Center
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RichmondUnited StatesRecruiting
University of Utah, Huntsman Cancer Hospital
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Salt Lake CityUnited StatesRecruiting
University of California San Francisco
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San FranciscoUnited StatesRecruiting
Cleveland Clinic Florida, Weston Hospital
Coordinator of this site? Confirm its status
WestonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.