Recruiting

Observational StudyScreening for AL Amyloidosis in Smoldering Multiple Myeloma

Sponsor:

Tufts Medical Center

Code:

NCT06365060

Conditions

Smoldering Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Smoldering Multiple Myeloma

Study ID

NCT06365060

Start date

May 1, 2024

Status verified date

Aug, 2025

Completion date

Feb 27, 2029

Anticipated

Primary completion date

Feb 27, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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.

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 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

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

Creating a network to enroll patients on a collaborative study requiring marrow and blood specimens, to collect data for a training set of likelihood statistics and to plan a future validation study. [ Time Frame: 5 years ]
Validating an NGS assay that identifies IGLV genes in clonal plasma cells [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Raymond Comenzo, MD

617-636-6454 raymond.comenzo@tuftsmedicine.org

Denis Toskic, BS

617-636-5907 denis.toskic@tuftsmedicine.org

Locations

University of Alabama Hospital

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Megan Maier

205-882-1041 mmaier@uabmc.edu

Principal Investigator:

Susan Bal, MD

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Principal Investigator:

Robert Vescio, MD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Jane Greenaway

415-269-8259 jane.greenaway@ucsf.edu

Principal Investigator:

Tom Martin, MD

Cleveland Clinic Florida, Weston Hospital

Recruiting

Weston, Florida, United States, 33331

Principal Investigator:

Chakra Chaulagain, MD

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Denis Toskic

617-636-5907 denis.toskic@tuftsmedicine.org

Principal Investigator:

Raymond Comenzo, MD

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

CUIMC Navigators

cancerclinicaltrials@cumc.columbia.edu

Principal Investigator:

Suzanne Lentzsch, MD

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Bayley Axelrod

axelrodb@mskcc.org

Principal Investigator:

Heather Landau, MD

Atrium Health Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Courtney Schepel

980-292-0817 courtney.schepel@atriumhealth.org

Principal Investigator:

Cindy Varga, MD

UNC Lineberger Comprehensive Cancer Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Kendall Conder

919-962-7473 Kendall_Conder@med.unc.edu

Principal Investigator:

Sascha Tuchman, MD

The Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator:

Naresh Bumma, MD

University of Utah, Huntsman Cancer Hospital

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Sharmilee Nuli

801-213-6203 sharmilee.nuli@hci.utah.edu

Principal Investigator:

Amandeep Godara, MD

VCU Medical Center

Recruiting

Richmond, Virginia, United States, 23219

Contacts

Tyler Phillips

804-828-9085 phillipst5@vcu.edu

Principal Investigator:

Hashim Mann, MD

More Information

Sponsor

Tufts Medical Center

Last update posted

Aug 6, 2025

Last verified

Aug, 2025

Keywords

SMM
AL Amyloidosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Tufts Medical Center on 2025-08-06.