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.
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.
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
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There are 14 Locations for this study
Birmingham Alabama, 35233, United States More Info
Principal Investigator
Los Angeles California, 90048, United States More Info
Principal Investigator
Orange California, 92868, United States More Info
Principal Investigator
San Francisco California, 94143, United States More Info
Principal Investigator
Weston Florida, 33331, United States More Info
Principal Investigator
Boston Massachusetts, 02111, United States More Info
Principal Investigator
Boston Massachusetts, 02215, United States More Info
Principal Investigator
New York New York, 10032, United States More Info
Principal Investigator
New York New York, 10065, United States More Info
Principal Investigator
Charlotte North Carolina, 28204, United States More Info
Principal Investigator
Durham North Carolina, 27705, United States More Info
Principal Investigator
Dallas Texas, 75390, United States More Info
Principal Investigator
Salt Lake City Utah, 84112, United States More Info
Principal Investigator
Richmond Virginia, 23219, United States More Info
Principal Investigator
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