protocolSection identificationModule nctId: NCT06365060, orgStudyIdInfo id: 00003143, secondaryIdInfos id: R01CA279808, type: NIH, link: https://reporter.nih.gov/quickSearch/R01CA279808, briefTitle: Screening for AL Amyloidosis in Smoldering Multiple Myeloma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2029-02-27, completionDateStruct date: 2029-02-27, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Tufts Medical Center, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: 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., conditionsModule conditions: Smoldering Multiple Myeloma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, outcomesModule primaryOutcomes 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., primaryOutcomes measure: Validating an NGS assay that identifies IGLV genes in clonal plasma cells, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama Hospital, city: Birmingham, state: Alabama, zip: 35233, country: United States, contacts name: Susan Bal, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, locations facility: Cedars-Sinai Medical Center, city: Los Angeles, state: California, zip: 90048, country: United States, contacts name: Robert Vescio, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, locations facility: University of California, Irvine, city: Orange, state: California, zip: 92868, country: United States, contacts name: Lisa Lee, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.78779, lon: -117.85311, locations facility: University of California, San Francisco, city: San Francisco, state: California, zip: 94143, country: United States, contacts name: Tom Martin, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Cleveland Clinic Florida, Weston Hospital, city: Weston, state: Florida, zip: 33331, country: United States, contacts name: Chakra Chaulagain, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.10037, lon: -80.39977, locations facility: Tufts Medical Center, city: Boston, state: Massachusetts, zip: 02111, country: United States, contacts name: Denis Toskic, BS, role: CONTACT, phone: 617-636-5907, email: denis.toskic@tuftsmedicine.org, contacts name: Raymond Comenzo, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Dana-Farber Cancer Institute, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Giada Bianchi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Columbia University Medical Center, city: New York, state: New York, zip: 10032, country: United States, contacts name: Suzanne Lentzsch, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Memorial Sloan Kettering Cancer Center, city: New York, state: New York, zip: 10065, country: United States, contacts name: Heather Landau, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Atrium Health Levine Cancer Institute, city: Charlotte, state: North Carolina, zip: 28204, country: United States, contacts name: Cindy Varga, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.22709, lon: -80.84313, locations facility: UNC Lineberger Comprehensive Cancer Center, city: Durham, state: North Carolina, zip: 27705, country: United States, contacts name: Sascha Tuchman, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.99403, lon: -78.89862, locations facility: UT Southwestern, Harold C. Simmons Comprehensive Cancer Center, city: Dallas, state: Texas, zip: 75390, country: United States, contacts name: Gurbakhash Kaur, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, locations facility: University of Utah, Huntsman Cancer Hospital, city: Salt Lake City, state: Utah, zip: 84112, country: United States, contacts name: Amandeep Godara, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.76078, lon: -111.89105, locations facility: VCU Medical Center, city: Richmond, state: Virginia, zip: 23219, country: United States, contacts name: Hashim Mann, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.55376, lon: -77.46026, hasResults: False