Multiple Myeloma Clinical Trial

Screening for AL Amyloidosis in Smoldering Multiple Myeloma

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.

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Full 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.

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Eligibility Criteria

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 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 is for people with:

Multiple Myeloma

Estimated Enrollment:

400

Study ID:

NCT06365060

Recruitment Status:

Not yet recruiting

Sponsor:

Tufts Medical Center

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There are 14 Locations for this study

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University of Alabama Hospital
Birmingham Alabama, 35233, United States More Info
Susan Bal, MD
Principal Investigator
Cedars-Sinai Medical Center
Los Angeles California, 90048, United States More Info
Robert Vescio, MD
Principal Investigator
University of California, Irvine
Orange California, 92868, United States More Info
Lisa Lee, MD
Principal Investigator
University of California, San Francisco
San Francisco California, 94143, United States More Info
Tom Martin, MD
Principal Investigator
Cleveland Clinic Florida, Weston Hospital
Weston Florida, 33331, United States More Info
Chakra Chaulagain, MD
Principal Investigator
Tufts Medical Center
Boston Massachusetts, 02111, United States More Info
Denis Toskic, BS
Contact
617-636-5907
[email protected]
Raymond Comenzo, MD
Principal Investigator
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Giada Bianchi, MD
Principal Investigator
Columbia University Medical Center
New York New York, 10032, United States More Info
Suzanne Lentzsch, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Heather Landau, MD
Principal Investigator
Atrium Health Levine Cancer Institute
Charlotte North Carolina, 28204, United States More Info
Cindy Varga, MD
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
Durham North Carolina, 27705, United States More Info
Sascha Tuchman, MD
Principal Investigator
UT Southwestern, Harold C. Simmons Comprehensive Cancer Center
Dallas Texas, 75390, United States More Info
Gurbakhash Kaur, MD
Principal Investigator
University of Utah, Huntsman Cancer Hospital
Salt Lake City Utah, 84112, United States More Info
Amandeep Godara, MD
Principal Investigator
VCU Medical Center
Richmond Virginia, 23219, United States More Info
Hashim Mann, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

400

Study ID:

NCT06365060

Recruitment Status:

Not yet recruiting

Sponsor:


Tufts Medical Center

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