Screening for AL Amyloidosis in Smoldering Multiple Myeloma

Last updated: December 31, 2024
Sponsor: Tufts Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Myeloma

Amyloidosis

Cancer

Treatment

N/A

Clinical Study ID

NCT06365060
00003143
R01CA279808
  • Ages > 40
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Patients 40 years of age and older

  • diagnosed with Smoldering Multiple Myeloma

  • 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 isinconsequential. The patient only needs to meet the age and dFLC criterion.

Exclusion

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 impairedPregnant women, pregnant minors, minors (i.e., individuals who are not yet adults),wards of the state, non-viable neonates, neonates of uncertain viability, andprisoners are not eligible

Study Design

Total Participants: 400
Study Start date:
May 01, 2024
Estimated Completion Date:
February 27, 2029

Study Description

This study is based on results from two prior studies in which 4 of 36 patients with SMM and none of 14 patients with MGUS were found to have AL. The hypothesis that we test with this protocol is that patients with (1) a pre-existing diagnosis of SMM, (2) free light chain (FLC) abnormalities, (3) IGLV genes associated with AL,(4) t(11;14) or gain 1q, and (5) NT-proBNP > 332pg/mL will have undiagnosed AL or risk of progression to AL. We will study the potential for SMM, the FLC screen, AL-related IGLV gene use, t(11;14) or gain 1q cytogenetic abnormalities, and NT-proBNP > 332pg/mL to be the variables in a likelihood algorithm for AL.

Connect with a study center

  • University of Alabama Hospital

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • University of California, Irvine

    Orange, California 92868
    United States

    Site Not Available

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • Cleveland Clinic Florida, Weston Hospital

    Weston, Florida 33331
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Atrium Health Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • UT Southwestern, Harold C. Simmons Comprehensive Cancer Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • University of Utah, Huntsman Cancer Hospital

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • VCU Medical Center

    Richmond, Virginia 23219
    United States

    Active - Recruiting

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