Actively Recruiting

Age: 40Years +
All Genders
NCT06365060

Screening for AL Amyloidosis in Smoldering Multiple Myeloma

Led by Tufts Medical Center · Updated on 2025-08-06

400

Participants Needed

13

Research Sites

251 weeks

Total Duration

On this page

Sponsors

T

Tufts Medical Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Screening for AL Amyloidosis in Smoldering Multiple Myeloma

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 eGFR is less than 50 mL/min/1.73m2, FLC ratio is not considered; must meet age and dFLC criteria
Not Eligible

You will not qualify if you...

  • Patients younger than 40 years of age
  • Previous finding of amyloid in other biopsies
  • Adults unable to consent, including cognitively impaired
  • Pregnant women and pregnant minors
  • Minors (individuals who are not adults)
  • Wards of the state
  • Non-viable neonates or neonates of uncertain viability
  • Prisoners

AI-Screening

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Trial Site Locations

Total: 13 locations

1

University of Alabama Hospital

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

3

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

4

Cleveland Clinic Florida, Weston Hospital

Weston, Florida, United States, 33331

Actively Recruiting

5

Tufts Medical Center

Boston, Massachusetts, United States, 02111

Actively Recruiting

6

Columbia University Irving Medical Center

New York, New York, United States, 10032

Actively Recruiting

7

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

8

Atrium Health Levine Cancer Institute

Charlotte, North Carolina, United States, 28204

Actively Recruiting

9

UNC Lineberger Comprehensive Cancer Center

Durham, North Carolina, United States, 27705

Actively Recruiting

10

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

11

UT Southwestern, Harold C. Simmons Comprehensive Cancer Center

Dallas, Texas, United States, 75390

Not Yet Recruiting

12

University of Utah, Huntsman Cancer Hospital

Salt Lake City, Utah, United States, 84112

Actively Recruiting

13

VCU Medical Center

Richmond, Virginia, United States, 23219

Actively Recruiting

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Research Team

R

Raymond Comenzo, MD

CONTACT

D

Denis Toskic, BS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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