[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100264823":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":54,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":10,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":10,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":10,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Observational (biospecimen collection)",null,"Patients undergo collection of blood samples every 6 months for 3 years. Patients may also undergo a biopsy, x-rays, PET\u002FCT scans, and\u002For MRI scans to check the status of disease at the discretion of the treating physician.",[13,14],"Procedure: Biospecimen Collection","Other: Laboratory Biomarker Analysis",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"PROCEDURE","Biospecimen Collection","Undergo collection of blood samples",[9],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"Laboratory Biomarker Analysis","Correlative studies",[9],[26],{"name":27,"affiliation":5,"role":28},"Krin Patel, MD","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Mei Huang","CONTACT","713-745-9901","mhuang3@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},[51,52],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},{"name":53,"role":28,"phone":10,"phoneExt":10,"email":10},"Krina Patel, MD",{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[57],{"name":58,"class":59},"National Cancer Institute (NCI)","NIH","100264823","observational-prospective-research-study-in-monoclonal-gammopathies-leading-to-myeloma-100264823",false,"NCT02726750","Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma","Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma (ORIGIN Study)","Inclusion Criteria:\n\n* Patients with monoclonal gammopathy of unknown significance. 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* Patients with smoldering multiple myeloma. 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\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 (each focal lesion must be 5 mm or more in size)\n* Prior or concurrent systemic treatment for asymptomatic monoclonal gammopathies\n\n  * Bisphosphonates are permitted\n  * Radiotherapy is not permitted\n  * Prior treatment with chemotherapy or investigational agents for asymptomatic gammopathies is not permitted\n* Plasma cell leukemia\n* Uncontrolled intercurrent illness including but not limited to active infection or psychiatric illness\u002Fsocial situations that would compromise compliance with study requirements","ALL","18 Years",{"count":70,"type":71},200,"ESTIMATED","OBSERVATIONAL","The goal of this study is to find markers that may help to predict why some patients who have monoclonal gammopathy of unknown significance (MGUS) or smoldering multiple myeloma (SMM) that have no signs or symptoms of disease (asymptomatic) develop multiple myeloma, while others do not. Studying markers such as age, level of proteins in blood, percent of abnormal blood cells in the bone marrow, genes in the abnormal blood cells, and bone abnormalities may help researchers to validate clinical and genomic predictors for future use in clinical practice.",[75,76],"Monoclonal Gammopathy of Undetermined Significance","Smoldering Plasma Cell Myeloma","2026-04-20",{"date":79,"type":80},"2026-04-21","ACTUAL",{"date":82,"type":80},"2015-12-14",{"date":84,"type":71},"2028-04-30",{"name":5,"class":6},1]