[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100449770":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":57,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":10,"eligibilityCriteria":68,"healthyVolunteers":65,"sex":69,"minAge":70,"maxAge":10,"enrollmentInfo":71,"targetDuration":10,"studyType":74,"phases":10,"briefSummary":75,"conditions":76,"keywords":10,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Observational (quality of life questionnaire)",null,"Patients complete quality of life questionnaires over 10-15 minutes at baseline and every 6 months for patients participating in an observational study or every month for patients participating in a treatment study for up to 3 years.",[13,14],"Other: Quality-of-Life Assessment","Other: Questionnaire Administration",[16,22],{"type":6,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"Quality-of-Life Assessment","Complete questionnaires",[9],[21],"Quality of Life Assessment",{"type":6,"name":23,"description":18,"armGroupLabels":24,"otherNames":10},"Questionnaire Administration",[9],[26],{"name":27,"affiliation":5,"role":28},"Melody E Becnel","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Melody Becnel, MD","CONTACT","832-206-9804","mrbecnel@mdanderson.org",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"M D Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-95.36327,29.76328,{"lat":48,"lon":47},[51,55],{"name":52,"role":32,"phone":53,"phoneExt":10,"email":54},"Mei Huang","713-745-9901","mhuang3@mdanderson.org",{"name":56,"role":28,"phone":10,"phoneExt":10,"email":10},"Elisabet E. Manasanch",{"type":58,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[60],{"name":61,"class":62},"National Cancer Institute (NCI)","NIH","100449770","quality-of-life-in-patients-with-asymptomatic-monoclonal-gammopathies-100449770",false,"NCT05136807","Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies","Inclusion Criteria:\n\n* Patients with either monoclonal gammopathy of unknown significance age \\>= 18 years old.\n\n  * Both criteria must be met:\n\n    * Serum monoclonal protein \\\u003C 3 g\u002FdL or urinary monoclonal protein \\\u003C 500 mg per 24 hours and clonal bone marrow plasma cells \\\u003C 10%\n    * Absence of myeloma defining events or amyloidosis\n* OR Patients with smoldering multiple myeloma age \\>= 18 years old.\n\n  * Both criteria must be met:\n\n    * Serum monoclonal protein \\>= 3 g\u002FdL or urinary monoclonal protein \\>= 500 mg per 24 hours and\u002For clonal bone marrow plasma cells 10-60%\n    * Absence of myeloma defining events or amyloidosis\n* Patients must be enrolled in clinical trials for SMM or MGUS at MD Anderson Cancer Center, including protocols PA15-0575 (NCT02726750) (Prospective observational study of clinical and genomic predictors of progression to myeloma in asymptomatic monoclonal gammopathies); 2015-0148 (Phase II single arm trial of Isatuximab in patients with intermediate and high risk smoldering multiple myeloma); and 2015-0371 (NCT02603887) (Pilot single arm, single center, open label trial of Pembrolizumab in patients with intermediate and high risk smoldering multiple myeloma) and any future clinical trials for MGUS and\u002For SMM that open at MD Anderson Cancer Center.\n* Only patients who are English or Spanish speaking are eligible.\n\nExclusion Criteria:\n\n* Evidence of myeloma defining events or biomarkers of malignancy due to underlying plasma cell proliferative disorder meeting at least one of the following\n\n  * Hypercalcemia: serum calcium \\> 0.25 mmol\u002FL (\\> 1 mg\u002FdL) higher than the upper limit of normal or \\> 2.75 mmol\u002FL (\\> 11 mg\u002FdL)\n  * Renal Insufficiency: creatinine clearance \\\u003C 40 ml\u002Fmin or serum creatinine \\> 2 mg\u002FdL\n  * Anemia: hemoglobin value \\\u003C 10 g\u002FdL or 2 g\u002FdL \\\u003C normal reference\n  * Bone lesions: one or more osteolytic lesions on skeletal radiography, computerized tomography (CT) or 2-deoxy-2\\[F-18\\] fluoro-D-glucose positron emission tomography CT (PET-CT).\n  * Clonal bone marrow plasma cell percentage \\>= 60%\n  * Involved: uninvolved serum free light chain ratio \\>= 100 measured by Freelite assay (The Binding Site Group, Birmingham, United Kingdom \\[UK\\])\n  * \\>1 focal lesions on magnetic resonance imaging (MRI) studies, if the patient has an MRI done per eligibility criteria (each focal lesion must be 5 mm or more in size)\n* Plasma cell leukemia.\n* Presence of cognitive impairment or delirium as determined by the primary clinician.","ALL","18 Years",{"count":72,"type":73},400,"ESTIMATED","OBSERVATIONAL","This study examines the quality of life in patients with monoclonal gammopathy of unknown significance and smoldering multiple myeloma. Collecting quality of life information from patients may help doctors learn more about the most common symptoms and concerns patients with monoclonal gammopathy of unknown significance and smoldering multiple myeloma may have.",[77,78],"Monoclonal Gammopathy of Undetermined Significance","Smoldering Plasma Cell Myeloma","2026-04-10",{"date":81,"type":82},"2026-04-15","ACTUAL",{"date":84,"type":82},"2016-06-07",{"date":86,"type":73},"2027-02-02",{"name":5,"class":6},1]