RECRUITING

Screening for AL Amyloidosis in Smoldering Multiple Myeloma

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Conditions

Smoldering Multiple MyelomaSMMAL Amyloidosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Screening for AL Amyloidosis in Smoldering Multiple Myeloma

Quick Facts

Study Start:2024-05-01
Study Completion:2029-02-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06365060

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients 40 years of age and older
  2. * diagnosed with Smoldering Multiple Myeloma
  3. * dFLC greater than 23 mg/L
  4. * abnormal FLC ratio
  5. * 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.
  1. * Patients younger than 40 years of age are not eligible
  2. * Patients with a previous finding of amyloid in other biopsies will not be included
  3. * 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

Contacts and Locations

Study Contact

Raymond Comenzo, MD
CONTACT
617-636-6454
raymond.comenzo@tuftsmedicine.org
Denis Toskic, BS
CONTACT
617-636-5907
denis.toskic@tuftsmedicine.org

Study Locations (Sites)

University of Alabama Hospital
Birmingham, Alabama, 35233
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
University of California, Irvine
Orange, California, 92868
United States
University of California, San Francisco
San Francisco, California, 94143
United States
Cleveland Clinic Florida, Weston Hospital
Weston, Florida, 33331
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, 28204
United States
UNC Lineberger Comprehensive Cancer Center
Durham, North Carolina, 27705
United States
UT Southwestern, Harold C. Simmons Comprehensive Cancer Center
Dallas, Texas, 75390
United States
University of Utah, Huntsman Cancer Hospital
Salt Lake City, Utah, 84112
United States
VCU Medical Center
Richmond, Virginia, 23219
United States

Collaborators and Investigators

Sponsor: Tufts Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-01
Study Completion Date2029-02-27

Study Record Updates

Study Start Date2024-05-01
Study Completion Date2029-02-27

Terms related to this study

Keywords Provided by Researchers

  • SMM
  • AL Amyloidosis

Additional Relevant MeSH Terms

  • Smoldering Multiple Myeloma