[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"smoldering-myeloma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:smoldering-myeloma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100591998","evaluating-the-impact-of-a-12-month-multi-modal-lifestyle-management-intervention-on-disease-relevant-biomarkers-100591998",false,"NCT06987708","Evaluating the Impact of a 12-month Multi-Modal Lifestyle Management Intervention on Disease Relevant Biomarkers","Evaluating the Impact of a 12-month Multi-Modal Lifestyle Management Intervention on Disease Relevant Biomarkers Associated With Monoclonal Gammopathy of Unknown Significance (MGUS) and Smoldering Myeloma (SM): A Prospective Intervention Pilot Study","Inclusion Criteria:\n\n* Adults 18 years or older.\n* Diagnosed with MGUS or SM based on commonly accepted criteria per the\n\nInternational Multiple Myeloma Working Group (IMWG), defined as follows:\n\na. For a diagnosis of Smoldering Multiple Myeloma (SM), both criteria must be met: i. Serum monoclonal protein (IgG or IgA) ≥ 30g\u002FL or urinary monoclonal protein ≥ 500mg per 24h and\u002For clonal bone marrow plasma cells 10-60% ii. Absence of myeloma-defining events or amyloidosis b. For a diagnosis of Non-IgM Monoclonal Gammopathy of Undetermined\n\nSignificance (MGUS):\n\ni. Serum monoclonal protein \\\u003C30g\u002FL ii. Clonal bone marrow plasma cells \\\u003C10% iii. Absence of end-organ damage such as hypercalcemia, renal insufficiency, anemia, and bone lesions (CRAB) or amyloidosis that can be attributed to the plasma cell proliferative disorder c. For a diagnosis of IgM MGUS: i. Serum IgM monoclonal protein \\\u003C30g\u002FL ii. No evidence of anemia, constitutional symptoms, hyperviscosity, lymphadenopathy, hepatosplenomegaly, or other end-organ damage that can be attributed to the plasma cell proliferative disorder d. For a diagnosis of light change MGUS: i. Abnormal FLC ratio (\\\u003C0.26 or \\>1.65) ii. Increased level of the appropriate free light chain (increased κ FLC in patients with ratio \\>1.65 and increased λ FLC in patients with ratio \\\u003C0.26) iii. No immunoglobulin heavy chain expression on immunofixation iv. Absence of end-organ damage such as hypercalcemia, renal insufficiency, anemia, and bone lesions (CRAB) or amyloidosis that can be attributed to the plasma cell proliferative disorder v. Clonal bone marrow plasma cells \\\u003C10% vi. Urinary monoclonal protein \\\u003C500mg\u002F24h\n\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2\n* Ability to speak, read and comprehend the English language.\n* Absence of significant intercurrent illness such as uncontrolled heart failure, unstable angina, cardiac arrhythmia and psychiatric illness which would preclude informed consent.\n* Patient understands the purpose of the trial and procedures required for the trial, and can provide signed informed consent as which includes compliances with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol.\n* Ability to adhere to the study visit schedule and all the protocol requirements, including surveillance imaging and test specimen (blood sample) collection at specified time points.\n\nExclusion Criteria:\n\n* Evidence of any one or more of the following biomarkers of malignancy, or myeloma-defining events (MDEs) meeting IMWG criteria for a diagnosis of multiple myeloma:\n\n  1. 60% or greater clonal plasma cells on bone marrow examination\n  2. Serum involved \u002F uninvolved free light chain ratio of 100 or greater, provided the absolute level of the involved light chain is at least 100mg\u002FL (a patient's involved free light chain either kappa or lambda is the one that is above the normal reference range; the uninvolved free light chain is the one that is typically in, or below, the normal range)\n  3. More than one focal lesion on MRI that is at least 5mm or greater in size.\n* Evidence of end-organ damage as per the IMWG CRAB criteria, defined as follows:\n\n  1. Hypercalcemia: serum calcium \\>0.25 mmol\u002FL (\\>1mg\u002FdL) higher than the upper limit of normal or \\>2.75 mmol\u002FL (\\>11mg\u002FdL)\n  2. Renal insufficiency: creatinine clearance \\\u003C40 mL per minute or serum creatinine \\>177mol\u002FL (\\>2mg\u002FdL)\n  3. Anemia: hemoglobin value of \\>20g\u002FL below the lowest limit of normal, or a hemoglobin value \\\u003C100g\u002FL\n  4. Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET\u002FCT. If bone marrow has \\\u003C10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement\n* Unwillingness or inability to follow required intervention behaviors, including any safety issues related to participating in any part of the intervention (e.g., a contraindication to gentle movement\u002Fexercise, BMI \\\u003C18 kg\u002Fm2, etc.).\n* Pregnancy or breastfeeding\n* Patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.","ALL","18 Years",{"count":19,"type":20},67,"ESTIMATED","INTERVENTIONAL",[23],"NA","A prospective, pilot study to assess the impact of a 12-month multi-focal lifestyle intervention on myeloma-relevant biomarkers in patients with MGUS or SM. The multimodal lifestyle intervention has six foci that patients will participate in over the course of one-year.",[26,27],"Monoclonal Gammopathy of Uncertain Significance","Smoldering Myeloma","NOT_YET_RECRUITING","2026-06-12",{"date":31,"type":32},"2026-06-15","ACTUAL",{"date":34,"type":20},"2026-07-01",{"date":36,"type":20},"2028-07-01",{"name":38,"class":39},"Hackensack Meridian Health","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":64},"100616442","exploring-the-effects-of-korean-style-mediterranean-diet-kormed-and-physical-activity-measurement-in-patients-with-mgussmm-a-pilot-study-100616442","NCT07305662","Exploring the Effects of Korean-Style Mediterranean Diet (KORMED) and Physical Activity Measurement in Patients With MGUS\u002FSMM: A Pilot Study","KORMED-PA Stud","Inclusion Criteria:\n\nParticipants must meet all of the following:\n\nAdults aged 19 to 80 years at the time of enrollment.\n\nDiagnosed with MGUS (Monoclonal Gammopathy of Undetermined Significance) or Smoldering Multiple Myeloma (SMM) according to standard criteria.\n\nAble and willing to follow a Korean-style Mediterranean diet (KORMED) for 12 weeks.\n\nAble to use a smartphone and wearable device to track daily physical activity.\n\nWilling to attend study visits and provide blood, stool, and questionnaire data at scheduled time points.\n\nAble to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Participants will not be eligible if they meet any of the following:\n\nDiagnosis of active multiple myeloma requiring treatment.\n\nCurrent participation in another interventional clinical trial.\n\nSevere liver, kidney, or heart disease that would make the diet or study procedures unsafe.\n\nUncontrolled infection or serious medical condition that may interfere with participation.\n\nHistory of major gastrointestinal surgery that prevents adherence to the diet.\n\nPregnant or breastfeeding, or planning to become pregnant during the study period.\n\nAllergy or intolerance to key components of the KORMED diet (e.g., fish, nuts, legumes) that prevents safe participation.\n\nAny condition, in the investigator's judgment, that would make participation unsafe or limit the ability to complete the study.","19 Years","80 Years",{"count":50,"type":20},20,[23],"This single-arm pilot study aims to evaluate the feasibility and potential health effects of a Korean-style Mediterranean diet (KORMED) and continuous physical activity measurement in patients with monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). The study investigates whether a 12-week KORMED dietary intervention, combined with monitoring of daily step counts using a wearable device, can improve metabolic and inflammatory biomarkers, body composition, gut microbiome diversity, and quality of life.\n\nThe study seeks to answer the following primary question:\n\nIs the KORMED diet feasible and achievable for MGUS\u002FSMM patients, as measured by changes in K-MEDAS adherence scores over 12 weeks?\n\nSecondary questions include:\n\n1. Does adherence to KORMED lead to improvements in BMI, inflammatory markers (CRP, IL-6), metabolic indicators (HOMA-IR, FLI), M-protein levels, and gut microbiome diversity?\n2. Is increased daily physical activity, measured by step counts, associated with favorable changes in metabolic and clinical parameters?\n3. Can combined dietary and activity-based lifestyle modification provide preliminary evidence supporting delayed disease progression in precursor plasma cell disorders?",[54,27],"Monoclonal Gammopathy of Undetermined Significance","2026-01-20",{"date":57,"type":32},"2026-01-21",{"date":59,"type":20},"2026-01-30",{"date":61,"type":20},"2027-07-15",{"name":63,"class":39},"Seoul National University Bundang Hospital",1]