[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"smoldering-multiple-myeloma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:smoldering-multiple-myeloma":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,52,79,105,127,147,167,192,218,241,264,289,315,337,363],{"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":4,"briefSummary":22,"conditions":23,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100229822","study-of-mgus-smoldering-myeloma-early-mds-and-cll-to-assess-molecular-events-of-progression-and-clinical-outcome-100229822",false,"NCT02269592","Study of MGUS, Smoldering Myeloma, Early MDS and CLL to Assess Molecular Events of Progression and Clinical Outcome","Study of Precursor Hematological Malignancies to Assess the Relationship Between Molecular Events of Progression and Clinical Outcome","Inclusion Criteria:\n\n* Patients with Known or Suspected Precursor Hematological Cancer\n* Including the following subgroups of diseases:\n\n  * Early MDS, including pathologically-confirmed MDS (IPSS Low\u002FInt-1; IPSS-R Very Low\u002FLow) and idiopathic cytopenias of undetermined significance (ICUS);\n  * Asymptomatic Multiple Myeloma and Waldenstrom Macroglobulinemia such as monoclonal gammopathy of undermined significance (MGUS) or Smoldering Multiple Myeloma (SMM or SWM);\n  * Monoclonal B cell lymphocytosis (MBL);\n  * Early stage asymptomatic low-grade lymphomas; or\n  * Other precursor conditions or clonal genetic abnormalities of the blood\u002Fbone marrow that do not meet criteria for symptomatic hematological malignancy, or patients exposed to prior chemotherapies (e. g., alkylating agents, platinum derivatives, taxanes, topo-2 inhibitors, anti-metabolites, systemic radioisotopes).\n* Patients must be at least 18 years of age to participate in this research.\n* Inclusion of Women and Minorities -- In accordance with NIH guidelines, women and members of minority groups and their subpopulations will be included in this protocol.\n\nExclusion Criteria:\n\n* Patients with Known or Suspected Precursor Hematological Cancer are NOT EXCLUDED\n* Evidence of symptomatic or active hematological malignancy. Patients enrolled on clinical trials for precursor diseases are NOT excluded from this study.","ALL","18 Years",{"count":19,"type":20},10000,"ESTIMATED","OBSERVATIONAL","Blood cancers occur when the molecules that control normal cell growth are damaged. Many of these changes can be detected by directly examining parts of the cancer or cells in blood. Several alterations that occur repeatedly in certain types of blood cancers have already been identified, and these discoveries have led to the development of new drugs that target those alterations. More remain to be discovered.\n\nSome of these abnormalities include alterations in genes. Genes are the part of cells that contain the instructions which tell the investigators bodies how to grow and work, and determine physical characteristics such as hair and eye color. Genes are composed of DNA letters that spell out these instructions. Studies of the DNA molecules that make up the genes are called \"molecular\" analyses. Molecular analyses are ways of reading the DNA letters to identify errors in genes that may contribute to an increased risk of cancer or to the behavior of the cancer cells. Some changes in genes occur only in cancer cells. Others occur in the genes that are passed from parent to child. This research study will examine both kinds of genes. The best way to find these genes is to study large numbers of people. The investigators expect that as many 1000 individuals will enroll in this study.\n\nThis research study is trying to help doctors and scientists understand why cancer occurs and to develop ways to better treat and prevent it. To participate in this study the participant must have cancer now, had it in the past, or are at risk of developing cancer. The participant will not undergo tests or procedures that are not required as part of their routine clinical care. The investigators will ask the participant to provide an additional sample from tissue that is obtained for their clinical care including blood, bone marrow, or tissue sample. The investigators will also ask for a gentle scrape of the inside of their cheek, mouthwash or a skin sample to obtain their germline DNA",[24,25,26,27,28,29,30,31],"Monoclonal Gammopathy of Undetermined Significance (MGUS)","Myelodysplastic Syndromes","Hematological Malignancies","B-cell Malignancy, Low-grade","Myelodysplastic Syndrome With Low-grade Lesions","IgG Monoclonal Gammopathy of Uncertain Significance","Smoldering Multiple Myeloma","Waldenstrom Macroglobulinemia",[33,34,35,31,36,37,30,38],"MGUS","Smoldering Myeloma","Acute Myeloid Leukemia","Monoclonal Gammopathy of Undermined Significance","Monoclonal B cell lymphocytosis","Myelodysplastic syndromes","RECRUITING","2026-05-04",{"date":42,"type":43},"2026-05-07","ACTUAL",{"date":45,"type":43},"2014-08",{"date":47,"type":20},"2030-09",{"name":49,"class":50},"Dana-Farber Cancer Institute","OTHER",7,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100627295","fast-m-prolonged-overnight-fasting-and-mediterranean-dietary-intervention-for-patients-with-multiple-myeloma-or-its-precursor-disease-100627295","NCT07446777","FAST-M: Prolonged Overnight Fasting and Mediterranean Dietary Intervention for Patients With Multiple Myeloma or Its Precursor Disease","Prolonged Overnight Fasting and Mediterranean Dietary Intervention for Patients With Multiple Myeloma or Its Precursor Disease (the FAST-M Study)","FAST-M","Inclusion Criteria:\n\n1. 18 years of age or older.\n2. Any sex\u002Fgender.\n3. Able to provide consent.\n4. Able to speak, read, and understand English or Spanish.\n5. Diagnosis of Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM), or Multiple Myeloma (MM) per standard criteria:\n\n   1. Cohort 1 - Participants must have a confirmed diagnosis of MGUS and SMM.\n   2. Cohort 2 - Participants must have a confirmed new diagnosis of MM and be initiating anti-myeloma therapy.\n6. Delivery of anti-myeloma therapies at one of the following institutions:\n\n   1. Sylvester Comprehensive Cancer Center (SCCC) (including satellite\u002Fnetwork sites).\n   2. University of Miami Health System.\n7. Approval from treating oncologist, confirmed via email or in writing.\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status grade of \\\u003C2\n\n   a. PI approval needed if ECOG ≥ 2.\n9. Having not consistently (not equal to or more than 50% of the time) engaged in structured fasting (i.e., not regularly fasting for ≥12hr\u002Fnight) for the past 3 months.\n10. Not consuming a Mediterranean diet by not meeting 2 or more out of the following 3 Mediterranean eating pattern goals in the prior 3 months: ≥3 servings of vegetables per day, ≥ 3 servings of beans and legumes per week, or ≥ 1 serving of nuts per day.\n\n    Mediterranean diet will be screened with select components of a Mediterranean Diet Adherence Screener (MEDAS).\n11. Internet access on a smart phone, tablet, or computer.\n12. Willing to be randomized to a prolonged overnight fasting and guided Mediterranean dietary intervention or waitlist-control group.\n\nExclusion Criteria:\n\n1. Individuals younger than 18 years of age.\n2. Unable to provide consent.\n3. Unable to read or understand English or Spanish.\n4. Any contraindication for diet changes as determined by physician.\n5. History of a clinical eating disorder.\n6. History of dementia or major psychiatric disease.\n7. History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure.\n8. History of autoimmune disease and on treatment at time of screening.",{"count":61,"type":20},120,"INTERVENTIONAL",[64],"NA","The purpose of this study is to find out whether a dietary approach that includes prolonged overnight fasting, guided by a Mediterranean-style eating pattern, is feasible for patients with myeloma precursor disease or newly diagnosed multiple myeloma.",[67,68,30],"Multiple Myeloma","Monoclonal Gammopathy of Undetermined Significance","2026-04-27",{"date":71,"type":43},"2026-05-01",{"date":73,"type":43},"2026-04-07",{"date":75,"type":20},"2029-04-30",{"name":77,"class":50},"University of Miami",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":62,"phases":88,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100488494","a-study-comparing-a-plant-based-diet-with-supplements-and-placebo-in-people-with-monoclonal-gammopathy-of-undetermined-significance-mgus-or-smoldering-multiple-myeloma-smm-100488494","NCT05640843","A Study Comparing a Plant-Based Diet With Supplements and Placebo in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM)","A Randomized Placebo Controlled Study of a Plant-Based Dietary Versus Supplement Versus Placebo Intervention in Patients With Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Multiple Myeloma (SMM) - The Nutrition Prevention (NUTRIVENTION-3) Study","Inclusion Criteria:\n\n* Confirmed diagnosis of MGUS or SMM\n* If non light chain MGUS\u002FSMM then M spike must be either ≥ 0.2 g\u002FdL or BM PC ≥10% (both not required)\n* If light chain MGUS\u002FSMM then involved must be ≥10 mg\u002FdL or BM PC ≥10% (both not required)\n* If IgA MGUS\u002FSMM then an IgA level \\>350 mg\u002FdL and an abnormal immunofixation is required (M spike criteria not required).\n* If IgD MGUS\u002FSMM then an IgD level \\>50 mg\u002FdL and an abnormal immunofixation is required (M spike criteria not required).\n* Age ≥18 years\n* Willingness to comply with all study-related procedures\n* ECOG performance status of 0-3\n* Interested in learning to cook plant based recipes\n\nExclusion Criteria:\n\n* Patients that already follow a whole foods plant based diet (ovo-lacto-vegetarian or processed junk food vegan diets are not excluded)\n* Legume allergy\n* Severe allergies such as anaphylactic shock to nuts (specifically cashews). Peanuts are not included in the meals.\n* Concurrent participation in weight loss\u002Fdietary\u002Fexercise programs\n* Mental impairment leading to inability to cooperate\n* Enrollment onto any other therapeutic investigational study concurrently and up to 180 days prior to study start date\n* Concurrent pregnancy\n* Positive HBV, HCV or HIV PCR test will need to be treated first and once undetectable viral load patients may enroll\n* ≥ Grade 2 electrolyte abnormalities as defined by CTCAEv5.0 (need to be resolved before enrolling on study)\n* If in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely or any contraindications\n* Heavy drinker (defined as \\>2 drinks per day or \\>14 drinks per week)\n* Current self-reported illicit drug use (eg heroin, cocaine not marijuana)\n* Plan for prolonged travel during the study that would preclude adherence to prescribed diets\n* History of major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment\n* If already taking curcumin or omega 3 supplements patients must be willing to stop it on the date of trial consent for study duration.",{"count":87,"type":20},180,[64],"The researchers are doing this study to look at how butyrate levels change in participants' stool after they are on a- plant-based diet for at least 12 weeks. All participants will have monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). We will compare how the plant-based diet, omega-3 fatty acid and curcumin supplements, and placebo (an inactive substance that looks like the study supplements) affect butyrate levels in participants' stool.",[68,30],[92,93,94],"Plant-Based Diet","Supplements","22-175","2026-04-15",{"date":97,"type":43},"2026-04-16",{"date":99,"type":43},"2022-11-29",{"date":101,"type":20},"2026-11",{"name":103,"class":50},"Memorial Sloan Kettering Cancer Center",8,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":112,"enrollmentInfo":113,"targetDuration":115,"studyType":21,"phases":4,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":124,"locationsCount":126},"100545533","promoting-diagnosis-and-management-of-al-in-italy-prodigality-100545533","NCT06383143","Promoting Diagnosis and Management of AL in Italy (ProDigALIty)","ProDigALIty","PART A\n\nInclusion Criteria:\n\n* diagnosis of MGUS with altered FLCR or SMM;\n* treatment-naïve;\n* age ≥18 years;\n* ability to understand and willingness to sign an informed consent;\n* planned follow-up at participating center.\n\nExclusion Criteria:\n\n* Diagnosis of symptomatic monoclonal gammopathies;\n* Previous treatment for monoclonal gammopathies.\n\nPART B\n\nInclusion criteria:\n\n* diagnosis of systemic AL amyloidosis;\n* treatment-naïve;\n* age ≥18 years;\n* ability to understand and willingness to sign an informed consent;\n* planned follow-up at participating center.\n\nExclusion criteria:\n\n* non-AL amyloidosis;\n* previous treatment for AL amyloidosis.","99 Years",{"count":114,"type":20},760,"2 Years","The investigators plan to establish a dedicated network of Italian Hematologic Departments interconnected with the Amyloidosis Research and Treatment Center in Pavia to:\n\n1. Implement a biomarker-based screening strategy to promote early diagnosis of AL amyloidosis among at-risk patients, including patients with monoclonal gammopathy of undetermined significance, MGUS, and altered free light chain ratio (aFLCR), and patients with smoldering multiple myeloma (SMM)\n2. Expedite and facilitate patients' referral and their enrollment in ongoing pre-clinical\u002Fclinical studies, also to reflect a broader spectrum of the real-world population of patients with AL amyloidosis in Italy;\n3. Investigate the clinical utility of novel diagnostic technologies, including light chain sequencing and N-glycosylation analysis",[118,30,68],"AL Amyloidosis","2026-04-13",{"date":97,"type":43},{"date":122,"type":43},"2023-05-01",{"date":71,"type":20},{"name":125,"class":50},"Fondazione IRCCS Policlinico San Matteo di Pavia",4,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":78},"100467049","two-biologically-and-clinically-distinct-entities-progressive-versus-stable-multiple-myeloma-mm-precursor-conditions-100467049","NCT05361694","Two Biologically and Clinically Distinct Entities: Progressive Versus Stable Multiple Myeloma (MM) Precursor Conditions","Two Biologically and Clinically Distinct Entities: Progressive Versus Stable Multiple Myeloma (MM) Precursor Conditions (TRANSFORMM)","TRANSFORMM","Inclusion Criteria:\n\n1. Diagnosis of MGUS and SMM will be made in accordance with the clinical diagnostic criteria set forth by the 2014 International Myeloma Working Group (IMWG) Revised Criteria.2\n2. The diagnoses will be confirmed by either serum\u002Furine protein electrophoresis, immunofixation and light-chain assays; or immunohistochemistry analyses of the bone marrow biopsy, or a combination of these tests.\n3. Age greater than or equal to 18 years.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.\n5. The patient must be competent to sign an informed consent form.\n\nExclusion Criteria:\n\n1. A diagnosis of MM as defined as any patient with detectable M-protein in blood and\u002For urine, monoclonal plasma cells in the bone marrow, and evidence of end-organ damage based on the Calcium Elevation, Renal Failure, Anemia, and Bone Disease (CRAB) criteria and\u002For myeloma-defining events.\n\n   * Patients who have received previous therapy for MM.\n   * Patients with known plasma cell or related lymphoid (e.g. lymphoplasmacytic lymphoma, Amyloid Light chain (AL) amyloidosis)\n2. Confirmation of pathological diagnosis is required either from the initial pathology review report or review from the UM\u002FSCCC Hematopathologist in accordance with the clinical diagnostic criteria set forth by the International Myeloma Working Group (IMWG) or World Health Organization (WHO). Tumor tissue that has been previously collected and is available for study or that can be collected with minimal additional risk to the patient during sampling required for routine patient care or required testing on a University of Miami (UM) \u002FSylvester Comprehensive Cancer Center (SCCC) research protocol will be used for diagnosis.\n3. Active symptomatic major organ disorder that would increase the risk of biopsy or other procedure, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, pulmonary dysfunction.\n\n   * Active concomitant medical or psychological illnesses that may increase the risk to the patient or inability to obtain informed consent, at the discretion of the Principal Investigator.\n   * Pregnant or breast-feeding women will not be eligible for any aspect of this protocol.\n   * Prisoners will be excluded.",{"count":136,"type":20},1000,"The key aim of the study is to define the two biologically and clinically distinct entities: progressive versus stable myeloma precursor conditions.",[67,30,68],"2026-04-06",{"date":141,"type":43},"2026-04-09",{"date":143,"type":43},"2022-04-12",{"date":145,"type":20},"2027-07-01",{"name":77,"class":50},{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":78},"100532401","smoldering-myeloma-high-risk-patient-observation-and-longitudinal-insight-trial-100532401","NCT06212323","Smoldering Myeloma High-Risk Patient Observation and Longitudinal Insight Trial","SPOTLIGHT","Inclusion Criteria:\n\n* Adult subject aged ≥ 18 years.\n* Diagnosis of smoldering myeloma as per the IMWG criteria, specifically:\n\n  * Serum monoclonal protein (IgG or IgA) of 30g\u002FL or greater per 24 hours or urinary monoclonal protein of 500mg or greater per 24 hours and\u002For\n  * Clonal bone marrow plasma cells 10-59% with the absence of myeloma-defining events or amyloidosis\n* High-risk smoldering myeloma defined as two or more out of four of the following criteria:\n\n  * M-spike greater than 2 g\u002FdL\n  * An involved\u002Funinvolved free light chain ratio greater than 20\n  * Bone marrow plasmacytosis greater than 20%\n  * Presence of any of translocation (4;14), deletion 17p, deletion 13q or 1q gain by conventional cytogenetics\u002Ffluorescence in situ hybridization (FISH) studies) and\u002For\n  * An IMWG SMM score of 9 or greater according to the IMWG risk model for smoldering multiple myeloma (SMM)\n* Diagnosis of high-risk SMM made within 365 days of enrollment in the study. Note: If a patient previously had MGUS or low\u002Fintermediate SMM- the date at which high-risk SMM was diagnosed would have to be within 365 days of enrollment in the study.\n\nExclusion Criteria:\n\n* Presence of any features that would meet diagnostic criteria for myeloma as per the IMWG Criteria\n* Presence of extramedullary plasmacytomas\n* Presence of any focal bone marrow lesions, or lytic bone lesions on imaging done prior to screening or on screening. However, presence of diffuse or patchy infiltration of the marrow (without any clear lesions) on MRI, will not be an exclusion criteria. Patients with 1 focal marrow lesion on MRI that is attributable to plasma cell dyscrasia, will be excluded from study, even if they do not meet criteria for myeloma. Patients with 1 focal marrow lesion can only be enrolled if the lesion does not appear to be related to myeloma, based on the judgement of the investigator. Use of restricted diffusion and ADC values can assist in ascertainment.\n* Creatinine clearance of less than 40ml\u002Fmin.\n* Presence of AL Amyloidosis (the amount of workup necessary to exclude AL Amyloidosis is per the discretion of the treating investigator, however the investigator must attest that they do not believe AL Amyloidosis to be present at time of enrollment. Serum nt-PROBNP is recommended as part of evaluation in order to ascertain for cardiac amyloidosis).\n\nNote: The Hgb cut-offs can vary between institutions (lower cut-off for Hgb University of Utah for men is a Hgb of 14.8, rendering a patient with Hgb of 12.7 as having a CRAB feature). If the Hgb is above 10g\u002Fdl but the patient meets the definition of anemia according to the IMWG criteria, by virtue of this being more than 2 g\u002Fdl below the limit of normal, the investigator can decide whether to call a patient being considered for screening as having multiple myeloma OR smoldering myeloma and allow enrollment on this study.\n\nGiven that the values used to define high-risk SMM can change, at time of enrollment, if utilizing at least 2\u002F4 of the 2\u002F20\u002F20+cytogenetics criteria to enroll, participants should meet at least 2\u002F4 of the 2\u002F20\u002F20. If participants had met at least 2\u002F4 previously at some timepoint but do not meet at least 2\u002F4 currently, they cannot be enrolled in the study.",{"count":155,"type":20},100,"The purpose of this study is to define the natural history of high-risk smoldering myeloma in a modern cohort of patients undergoing close standard of care follow-up with diffusion weighted whole body magnetic resonance imaging.",[30],"2026-02-11",{"date":160,"type":43},"2026-02-17",{"date":162,"type":43},"2024-01-11",{"date":164,"type":20},"2030-03",{"name":166,"class":50},"University of Utah",{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":191},"100534359","european-myeloma-network-emn-sample-project-100534359","NCT06237803","European Myeloma Network (EMN) Sample Project","EMN Prospective Sample Collection Project","EMN36","Inclusion Criteria:\n\n* Subjects with MGUS, smouldering Multiple Myeloma (SMM) , MM (Multiple Myeloma) (+\u002F- EMD), plasma cell leukemia (PCL) (+\u002F- EMD)\n* Subjects are ≥ 18 years old.\n* Subjects have provided written informed consent in accordance with federal, local, and institutional guidelines prior to initiation of any project-specific activities or procedures.\n\n  1. Subjects do not have kind of condition that, in the opinion of the Investigators, may compromise the ability of the subjects to give written informed consent and\n  2. subjects are, in the investigator's opinion, willing and able to comply with the protocol requirements.\n\nExclusion Criteria:\n\n* Previous treatment with anti-myeloma therapy (excluding one course of therapy in patients in which urgent therapy is deemed necessary according to physician's discretion, e.g. myeloma-related complications resistant to supportive care).\n* Subjects have had prior unforeseen (serious) adverse reactions to blood donation including, but not limited to fainting, angina, severe bruising, allergic reactions, or any other adverse events.\n* Any psychological, familial, sociological and geographical condition potentially hampering compliance with the protocol and follow-up schedule.",{"count":176,"type":20},6000,"This is an observational, non-interventional, multicenter study for the prospective collection, storage and analysis of patients' biological samples.\n\nThis study establishes a common international infrastructure useful to collect standard clinical variables at baseline and during treatment and to uniformly collect and store biological samples",[67,30,179,180,33],"Plasma Cell Leukemia","Extramedullary Myeloma","2025-12-02",{"date":183,"type":43},"2025-12-03",{"date":185,"type":43},"2022-12-21",{"date":187,"type":20},"2037-12",{"name":189,"class":190},"European Myeloma Network B.V.","NETWORK",41,{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":198,"targetDuration":200,"studyType":21,"phases":4,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":78},"100340846","registry-for-adults-with-plasma-cell-disorders-pcds-100340846","NCT03717844","Registry for Adults With Plasma Cell Disorders (PCD's)","Inclusion Criteria:\n\n* Patients have an outpatient appointment or are hospitalized inpatient at UNC Cancer Hospitals, or affiliated clinic settings or participating sites for the evaluation and management of a PCD.\n* Patients have a documented diagnosis of PCD defined as the presence of a monoclonal protein and\u002For monoclonal plasma cell population. Examples of PCDs include but are not limited to monoclonal gammopathy of uncertain significance; smoldering myeloma; multiple (active) myeloma; plasma cell leukemia; Castleman's disease; amyloidosis; light and\u002For heavy chain deposition disease; Polyneuropathy, Organomegaly, Endocrinopathy,Monoclonal gammopathy and Skin changes (POEMS) syndrome; and cryoglobulinemia.\n* Age ≥18 years.\n* Must consent to participation in this study and agree to complete the assessment at baseline and follow-up time points.\n* Must be able to read and speak English.\n\nExclusion Criteria:\n\n* Physical or psychiatric\u002Fbehavioral illnesses or problems that the treating clinician feels would preclude successful participation in the study.\n* There are no imaging or lab studies required to determine eligibility.",{"count":199,"type":20},2000,"10 Years","The primary purpose of this protocol is to create a registry of patients with plasma cell disorders (PCDs), including for example the cancer multiple myeloma (MM), who complete the assessment, previously known as a \"geriatric assessment,\" as is outlined in this protocol. Secondary objectives include measuring the response rate to participation of patients in this study, assessing patient satisfaction with the questionnaire, and gathering information that would lend support for future research into these types of assessments in patients with PCDs. Additionally the study offers an optional blood draw to look at a genetic marker of aging called p16INK4a (IRB 15-1899, IRB 15-0244).",[67,203,204,205,206,207,208,30,179],"Amyloidosis","Cryoglobulinemia","Castleman's Disease","Light Chain Deposition Disease","Heavy Chain Deposition Disease","Polyneuropathy Organomegaly Endocrinopathy Monoclonal Gammopathy and Skin Changes","2025-11-19",{"date":211,"type":43},"2025-11-20",{"date":213,"type":43},"2018-02-09",{"date":215,"type":20},"2029-02",{"name":217,"class":50},"UNC Lineberger Comprehensive Cancer Center",{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":16,"minAge":224,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":227,"conditions":228,"keywords":229,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":240},"100544144","screening-for-al-amyloidosis-in-smoldering-multiple-myeloma-100544144","NCT06365060","Screening for AL Amyloidosis in Smoldering Multiple Myeloma","Inclusion Criteria:\n\n* Patients 40 years of age and older\n* diagnosed with either Smoldering Multiple Myeloma or a Monoclonal Gammopathy\n* dFLC greater than 23 mg\u002FL\n* abnormal FLC ratio\n* If the patient has an eGFR less than 50 mL\u002Fmin\u002F1.73m2, the FLC ratio is inconsequential. The patient only needs to meet the age and dFLC criterion.\n\nExclusion Criteria:\n\n* Patients younger than 40 years of age are not eligible\n* Patients with a previous finding of amyloid in other biopsies will not be included\n* 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","40 Years",{"count":226,"type":20},400,"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.",[30],[230,118],"SMM","2025-08-01",{"date":233,"type":43},"2025-08-06",{"date":235,"type":43},"2024-05-01",{"date":237,"type":20},"2029-02-27",{"name":239,"class":50},"Tufts Medical Center",13,{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":62,"phases":250,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":78},"100503921","phase-1-the-tg01-study-with-tg01qs-21-vaccine-in-patients-with-high-risk-smouldering-multiple-myeloma-and-multiple-myeloma-100503921","NCT05841550","The TG01 Study With TG01\u002FQS-21 Vaccine in Patients With High-risk Smouldering Multiple Myeloma and Multiple Myeloma","A Phase 1\u002FPhase 2 Study to Investigate Safety, Tolerability and Efficacy With TG01\u002FQS-21 Vaccine Administration in Patients With Confirmed KRAS or NRAS Codon 12\u002F13 Mutation and High-risk Smoldering Multiple Myeloma or Multiple Myeloma and Evidence of Measurable Disease ≥ 1 Line of Treatment","Inclusion Criteria:\n\n* Male or female patients ≥ 18 years of age\n* RAS mutation (KRAS\u002FNRAS codon 12\u002F13 mutation) detected on archival or fresh bone marrow material with VariantPlex Myeloid Panel\n* Confirmed diagnosis of high-risk smoldering multiple myeloma (SMM) according to IMWG criteria (30) and high-risk criteria as listed up below OR confirmed diagnosis of multiple myeloma (MM) according to IMWG criteria and measurable disease following ≥\n\n  1 line of treatment\n* In patients with high-risk SMM at least 2 of 3 following abnormalities, based on laboratory data obtained at screening must be fulfilled:\n\n  1. Serum M-protein \\>20 g\u002FL.\n  2. Serum involved\u002Funinvolved FLC ratio \\>20.\n  3. BMPC \\>20%. OR presence of ≥10% BMPC and at least one of the following based on laboratory data obtained at screening:\n\n     * Serum M-protein ≥30 g\u002FL (If IgA, IgA ≥20g\u002FL)\n     * Serum involved\u002Funinvolved FLC ratio ≥8 (but \\\u003C100)\n     * Abnormal PC immunophenotype (≥95% of BMPCs are clonal) and reduction of ≥1uninvolved Ig isotype (Only IgG, IgA and IgM will be considered)\n     * Progressive increase in Serum M-protein level (evolving type of SMM) defined as an increase of Serum M-protein ≥10% in the last 12 months before enrolment in the study. This increase must be consistent from one to another sample (i.e., no decrease observed between 2 increased Serum M-protein values)\n* Both high-risk SMM and MM patients must have evidence of measurable disease in accordance with IMWG criteria\n* If patient with MM was eligible for ASCT, ASCT must have been performed, and patients cannot be enrolled until 3 months after ASCT\n* Patient should not be expected to require immediate, subsequent line of treatment for at least 2 months\n* Patient has not had reduction of clonal plasma cell markers for last two cycles (last two months if off treatment). If a patient had no reduction during the last two cycles of induction before ASCT, the patient can be enrolled, provided 3 months after ASCT\n* Following ASCT, the patient cannot be enrolled without having tried lenalidomide maintenance given at standard doses for at least two cycles, if the clonal markers had a reduction during the last 2 cycles of induction treatment. Lenalidomide will be stopped when entering the study\n* ECOG performance status 0-1\n* Female patients of child-bearing potential (FCBP) must have negative serum pregnancy test at Screening and agree to use a highly effective method of contraception during treatment and for 3 months following last dose of drug.\n* Male patients must use an effective barrier method of contraception during treatment and for 3 months following the last dose if sexually active with a FCBP.\n* Ability to provide written informed consent and can understand and comply with the requirements of the study\n\nExclusion Criteria:\n\n* Pregnant or lactating women or women without a pregnancy test at baseline (postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential)\n* Medical conditions such as but not limited to:\n\n  1. Any uncontrolled infection\n  2. Uncontrolled cardiac failure classification III or IV (NYHA)\n  3. Uncontrolled systemic and gastro-intestinal inflammatory conditions\n  4. History of adverse reactions to vaccines\n* Active malignancy with worse prognosis than multiple myeloma\n* Likely to require treatment intervention for multiple myeloma within two months of start of treatment with TG01\u002FQS-21\n* Known history of positive tests for HIV\u002FAIDS, hepatitis B or C\n* Planned to receive yellow fever or other live (attenuated) vaccines during the course of study\n* Known hypersensitivity to QS-21.\n* Only participants who are able to consent will be included in the study.",{"count":249,"type":20},20,[251,252],"PHASE1","PHASE2","The goal of this clinical trial is to test the safety, tolerability, and efficacy of TG01 vaccination in patients with KRAS or NRAS mutation on codon 12\u002F13 mutation who has multiple myeloma or high-risk smoldering multiple myeloma. The main question it aims to answer are:\n\nIs TG01\u002FQS-21 vaccination safe and tolerable for this patient group? Is TG01\u002FQS-21 vaccination treatment efficient in this group in terms of increased overall response rate, overall survival rate, progression-free survival, and time til next treatment? Is there an immunological response to the vaccine? Participants will be given TG01\u002FQS-21 vaccination treatment. Treatment consists of 12 doses of TG01\u002FQS-21 vaccine given every two weeks in the first 12 weeks, followed by every eight weeks until week 52.",[67,30],"2025-07-31",{"date":257,"type":43},"2025-08-05",{"date":259,"type":43},"2023-05-19",{"date":261,"type":20},"2035-05-19",{"name":263,"class":50},"Oslo University Hospital",{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":62,"phases":273,"briefSummary":274,"conditions":275,"keywords":277,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":288},"100475358","phase-2-immuno-prism-precision-intervention-smoldering-myeloma-100475358","NCT05469893","Immuno-PRISM (PRecision Intervention Smoldering Myeloma)","Immuno-PRISM (PRecision Intervention Smoldering Myeloma): A Randomized Phase II Platform Study of Select Immunotherapies for High-Risk Smoldering Myeloma","Inclusion Criteria:\n\n* Age ≥18 years.\n* 1\\) High risk SMM defined as having 1 of the following 2 criteria: High risk per \"20-2-20\" Criteria defined as presence of any two of the following:\n\n  \\-- Serum M spike ≥ 2 gm\u002FdL, Involved to uninvolved free light chain (FLC) ratio≥ 20, Bone marrow Plasma Cell (BMPC) % ≥ 20%\n* OR total score of 9 using the following scoring system:\n\n  * FLC Ratio \\>10-25 = 2, \\>25-40 = 3, \\> 40 = 5\n  * Serum M-Protein (g\u002FdL) \\>1.5-3 = 3, \\>3 = 4\n  * BMPC% \\>15-20 = 2, \\>20-30 = 3, \\>30-40 = 5, \\>40 = 6\n* Fluorescence In Situ Hybridization (FISH) abnormality (t(4,14), t(14,16), 1q gain, or del13q = 2\n* 2\\) Presence of ≥10% BMPC and at least one of the following:\n\n  \\-- Evolving pattern:\n  * evolving Monoclonal Protein (eMP) (≥10% increase in Monoclonal Protein\u002FImmunoglobulin (Ig)) within the first 6 months (only if M-protein ≥3 g\u002Fdl) and\u002For ≥25% increase in M\u002FIg within the first 12 months, with a minimum required increase of 0.5 g\u002Fdl in M-protein and\u002For 500 mg\u002Fdl in Ig.\n  * Evolving change in hemoglobin (eHb) ≥0.5 g\u002Fdl decrease within 12 months of diagnosis;\n  * Progressive involved light chain increase on two successive evaluation\n  * Abnormal Plasma Cell immunophenotype (≥ 95% of BMPCs are clonal) and reduction of ≥1 uninvolved immunoglobulin isotype. (Only IgG; IgA and IgM will be considered)\n  * High risk cytogenetics defined as presence of t(4;14), t(14;16), t(14;20), 17p deletion, TP53 mutation, 1q21 gain\n  * Monoclonal light chain excretion of \\> 200mg\u002F24 hours for those with monoclonal light chain SMM\n* No evidence of CRAB criteria\\* or new criteria of active MM (SLIM-CRAB) which include the following:\n\n  * Increased calcium levels: Corrected serum calcium \\>0.25 mmol\u002FL (\\>1mg\u002FdL) above the upper limit of normal or \\>2.75 mmol\u002FL (\\>11mg\u002FdL);\n  * Renal insufficiency (attributable to myeloma);\n  * Anemia (Hgb 2g\u002FdL below the lower limit of normal or \\\u003C10g\u002FdL);\n  * Bone lesions (lytic lesions or generalized osteoporosis with compression fractures)\n  * No evidence of the following new criteria for active MM including the following:\n\n    * Bone marrow plasma cells \\>60%\n    * Serum involved\u002Funinvolved FLC ratio ≥100\n    * MRI with more than one focal lesion\n* Participants with CRAB criteria that are attributable to conditions other than the disease under study may be eligible after discussion with the Sponsor Investigator.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1, or 2\n* The following laboratory values obtained \\\u003C28 days prior to registration:\n\n  * Absolute Neutrophil Count (ANC) \\>1000\u002FmL\n  * Platelets Count (PLT) \\>75,000\u002FmL\n  * Total bilirubin ≤ 2.0 mg\u002FdL (If total is elevated check direct and if normal patient is eligible.)\n  * Aspartates Aminotransferase (AST) \\\u003C2.5 x institutional upper limit of normal (ULN)\n  * Alanine Transaminase (ALT) \\\u003C2.5 x institutional upper limit of normal (ULN)\n  * Estimated creatinine clearance (CLcr) ≥60 mL\u002Fmin\n* Voluntary written informed consent will be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.\n* Females of child-bearing potential\\* randomized to Lenalidomide must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU\u002FmL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days as required by Revlimid Risk Evaluation and Mitigation Strategies (REMS®) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide.\n\n  * A female of child-bearing potential is a sexually mature female who: has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries), or has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months)\n  * A woman must be . A Not of childbearing potential, or b. Of childbearing potential and Practicing true abstinence; or Have a sole partner who is vasectomized; or Practicing ≥1 highly-effective, user-independent method of contraception NOTE: Participant must agree to continue the above throughout the study and for 90 days after the last dose of study treatment.\n\nNOTE: If a woman becomes of childbearing potential after start of the study the woman must comply with point (b) as described above.\n\nNOTE: An interaction between hormonal contraception and teclistamab has not been formally studied. Therefore, it is unknown whether teclistamab may reduce the efficacy of the contraception method.\n\n* A woman must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study and for 90 days after receiving the last dose of study treatment\n* A man must wear a condom (with or without spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository) when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 90 days after receiving the last dose of study treatment. If a female partner is of childbearing potential, she must also be practicing a highly effective method of contraception\n* If the male participant is vasectomized, he still must wear a condom (with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository), but his female partner is not required to use contraception.\n* A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study treatment.\n* Must be willing and able to adhere to the lifestyle restrictions specified in this protocol\n* All study participants randomized to lenalidomide must be registered into the mandatory Revlimid REMS® program and be willing and able to comply with the requirements of the REMS® program.\n* Females of child-bearing potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program if randomized to lenalidomide\n* Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy\n* Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Prior SMM directed therapy administered within 6 months of beginning treatment on study. To avoid including primary refractory cases to the lenalidomide arm, participants who received a prior lenalidomide-based therapy should have had at least an Minimal Response (MR) to be considered on this trial.\n* Symptomatic Multiple Myeloma or any evidence of CRAB criteria, including presence of myeloma defining events (MDE). Any prior therapy for active Myeloma should also be excluded. Prior therapy for smoldering myeloma is not an exclusion criterion. Bisphosphonates are not excluded\n* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational. Prior therapy with bisphosphonate is allowed. Prior radiation therapy to a solitary plasmacytoma is allowed but had to be at least 6 months prior to enrollment on the trial. Prior clinical trials or therapy for smoldering MM or Monoclonal Gammopathy of Unknown Significance (MGUS) are allowed per exclusion criteria described above.\n* Serious medical or psychiatric illness likely to interfere with participation in this clinical study.\n* Diagnosed or treated for another malignancy within 2 years of enrollment\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Plans to father a child while enrolled in this study or within 90 days after receiving the last dose of study drug.\n* Pregnant or breast-feeding or planning to become pregnant while enrolled in this study or within 90 days after receiving the last dose of study drug.\n* Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) or SARS-CoV-2 (COVID- 19).\n* Participants who are seropositive because of hepatitis B virus vaccine are eligible.\n* Participants who are positive for SARS-COV-2 antibody, HIV1 and 2 antibody, hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded.\n* Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to the teclistamab Investigator's Brochure and appropriate package inserts).\n* Prior or concurrent exposure to any of the following:\n* Investigational vaccine within 4 weeks\n* Live, attenuated vaccine within 4 weeks before randomization.\n* Monoclonal antibody therapy within 21 days\n* Cytotoxic therapy within 14 days\n* PI therapy within 14 days\n* IMiD agent therapy within 14 days\n* Radiotherapy within 14 days or focal radiation within 7 days\n* A maximum cumulative dose of corticosteroids of ≥140 mg of prednisone or equivalent within 14-day period before the first dose of study drug (does not include pretreatment medications)\n* Known active Central Nervous System (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI and lumbar cytology are required.\n* Myelodysplastic syndrome or active malignancies (i.e., progressing or requiring treatment change in the last 24 months). The only allowed exceptions are: a. Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured b. Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured. c. Noninvasive cervical cancer treated within the last 24 months that is considered completely cured d. Localized prostate cancer (N0M0): With a Gleason score of ≤6, treated within the last 24 months, or untreated and under surveillance With a Gleason score of 3+4 that has been treated \\>6 months prior to full study screening and considered to have a very low risk of recurrence, or e. History of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence. f. Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence. g. Other malignancy that is considered cured with minimal risk of recurrence\n* Stroke or seizure within 6 months prior to signing informed consent form\n* Presence of the following cardiac conditions:\n\n  \\-- New York Heart Association stage III or IV congestive heart failure, 2) Myocardial infarction or coronary artery bypass graft ≤6 months prior to randomization,3) History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration,4) History of severe non-ischemic cardiomyopathy\n* Major surgery within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment. NOTE: Participants with planned surgical procedures to be conducted under local anesthesia may participate. Kyphoplasty or vertebroplasty are not considered major surgery. If there is a question whether a procedure is considered a major surgery, the investigator must consult with the appropriate sponsor representative and resolve any issues before enrolling a participant in the study.\n* Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study, such as:\n* Uncontrolled diabetes defined by Hemoglobin A1C \\> 8.5, Acute diffuse infiltrative pulmonary disease, Evidence of active systemic viral, fungal, or bacterial infection, requiring systemic, antimicrobial therapy, History of autoimmune disease with the exception of vitiligo, type I diabetes, and, prior autoimmune thyroiditis that is currently euthyroid based on clinical symptoms and laboratory testing, . Disabling psychiatric conditions (e.g., alcohol or drug abuse), severe dementia, or altered mental status, Any other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the wellbeing) or that could prevent, limit, or confound the protocol-specified assessments, History of non-compliance with recommended medical treatments",{"count":272,"type":20},52,[252],"The purpose of this study is to test the anti-cancer activity of Teclistamab and to compare it with Lenalidomide + Dexamethasone combination in people with high risk smoldering multiple myeloma.\n\nPeople with smoldering multiple myeloma (SMM) usually do not have symptoms but are at risk for progressing to active multiple myeloma (MM). Multiple Myeloma is a cancer of the plasma cells, which are an important part of the immune system. Patients with active multiple myeloma generally require treatment but there are currently no approved therapies for smoldering multiple myeloma.\n\nThe names of the study drugs involved in this study are:\n\n* Teclistamab\n* Lenalidomide (also called Revlimid)\n* Dexamethasone (also called Decadron)",[276,30,67],"High-risk Smoldering Multiple Myeloma",[278,30,67],"High-risk smoldering Multiple Myeloma","2025-04-22",{"date":281,"type":43},"2025-04-24",{"date":283,"type":43},"2022-08-10",{"date":285,"type":20},"2030-07-31",{"name":287,"class":50},"Irene Ghobrial, MD",3,{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":297,"conditions":298,"keywords":302,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":288},"100584894","whole-body-mri-in-oncology-100584894","NCT06895291","Whole Body MRI in Oncology","ONCO-MRI","Inclusion Criteria:\n\n* Patients candidate to WB-MRI according to clinical practice belonging to the study groups listed above.\n* Participant is willing and able to give informed consent for participation in the study.\n* Male or Female, aged ≥ 18 years.\n* Life expectancy greater than 3 months.\n\nExclusion Criteria:\n\n* Patients with MRI-unsafe prostheses and devices.\n* Patients whose tests are of suboptimal quality, or whose test has been suspended, or is incomplete.",{"count":136,"type":20},"Multicenter, observational, prospective, study. All patients will be treated and monitored according to the local clinical practice. No additional procedures\u002Fpatient visits in comparison with the usual clinical practice are planned for the study.",[299,300,301,68,30,67],"Lymphoma","Advanced Prostate Cancer","Advanced Breast Cancer",[68,303,304,301,300,299,305],"Smoldering multiple myeloma","Multiple myeloma","Whole Body-Magnetic Resonance Imaging","2025-03-25",{"date":308,"type":43},"2025-03-30",{"date":310,"type":43},"2023-10-26",{"date":312,"type":20},"2031-10",{"name":314,"class":50},"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS",{"id":316,"slug":317,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":62,"phases":323,"briefSummary":324,"conditions":325,"keywords":326,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":78},"100485151","phase-2-selinexor-for-the-treatment-of-intermediate-and-high-risk-smoldering-multiple-myeloma-100485151","NCT05597345","Selinexor for the Treatment of Intermediate and High-Risk Smoldering Multiple Myeloma","Selinexor for the Treatment of Patients with Intermediate and High-Risk Smoldering Multiple Myeloma","Inclusion Criteria:\n\n* Age \\>\u002F= 18 years\n* Histologically confirmed diagnosis of SMM according to the IMWG definition: serum M-protein \\>\u002F= 3 g\u002FdL or BMPC \\>10% but \\\u003C60%, or both.\n* Should not meet CRAB criteria: hypercalcemia, anemia, bone lesions, or renal insufficiency thought to be related to the plasma cell disorder.\n* Should have 1 of the following risk factors to be considered intermediate risk and 2 or more risk factors to be considered high-risk:\n* BMPC\\>\u002F=20%\n* M-spike \\>\u002F= 2g\u002FdL\n* Involved to uninvolved sFLC ratio of \\>\u002F= 20\n* normal hepatic function within 28 days prior to C1D1\n* Adequate renal function within 28 days prior to C1D1. Estimated creatinine clearance (CrCl) calculated using formula of Cockcroft and Gault. CrCl \\>\u002F= 15 mL\u002Fmin.\n* Adequate hematopoietic function within 28 days prior to C1D1: absolute neutrophil count (ANC)\\>\u002F=1.5 x10\\^9\u002FL, hemoglobin \\>\u002F=10g\u002FdL, platelets \\>\u002F150x10\\^9\u002FL.\n* Life expectancy of \\>12 months.\n* ECOG PS 0-1\n* Subjects with reproductive potential must use 2 highly effective methods of effective contraception or practice sexual abstinence throughout the study and continue for 6 months after the study has closed. Subjects who are surgically sterile (e.g., history of bilateral tubal ligation, hysterectomy, or whos partner is sterile are not required to use additional modes of contraception.\n* Ability to understand and willingness\n\nExclusion Criteria:\n\n* Meets criteria for symptomatic MM as defined by any of the following, determined to be related to the plasma cell disorder\n\n  * Hypercalcemia (corrected serum calcium \\>11.0 mg\u002FdL)\n  * Renal insufficiency (creatinine \\>2.0 mg\u002FdL)\n  * Anemia (hemoglobin \\\u003C10g\u002FdL)\n  * One or more osteolytic bone lesions on radiography, but more than one lesion required if \\\u003C10% clonal bone marrow plasma cells. Based on MRI imaging, there must be more than one lesion \\>5mm in size.\n  * Clonal bone marrow plasma cells ≥60%\n  * An involved serum free light chain ≥ 100mg\u002FL with the ratio of the involved\u002Funinvolved free light chains also ≥100\n* Documented systemic light chain amyloidosis\n* Systemic corticosteroids \\>10mg prednisone (or equivalent) daily for other medical conditions.\n* Active invasive malignancy within the past 3 years that may affect the results or interfere with the interpretation of results of this study.\n* Non-invasive malignancy that was not treated with curative intent within the past 3 years that may affect the results or interfere with the interpretation of the results of this study.\n* Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 14 days of the receiving the first dose\n* Known active HIV infection without adequate anti-retroviral therapy\n* Active gastrointestinal dysfunction that prevents patient from swallowing tablets or may interfere with absorption of study treatment\n* Pregnant, breast feeding, or planning to become pregnant within 6 months after the end of treatment.\n* Subject of reproductive potential that is not willing to use two methods of highly effective contraception during treatment period and for 6 months after the end of treatment.\n* Any major medical or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results.\n* Prior exposure to a SINE compound, including Selinexor.",{"count":5,"type":20},[252],"Selinexor is a drug that has been approved in the treatment of patients with symptomatic multiple myeloma. The standard of care for patients with Smoldering Multiple Myeloma remains observation, but there are numerous clinical trials investigating interventions to delay progression to multiple myeloma and prevent or delay disease related outcomes. A subset of patients with intermediate or high risk smoldering multiple myeloma have a much higher risk of progressive to multiple myeloma, while the low risk smoldering myeloma patient population has a much lower risk. This is a clinical trial investigating the use of low-dose selinexor in patients with intermediate to high-risk smoldering multiple myeloma. The investigators hypothesize that the use of selinexor in intermediate to high risk smoldering myeloma patients will help to delay progression of disease to symptomatic multiple myeloma.",[30],[30,34,67,327,33],"Myeloma","2025-02-05",{"date":330,"type":43},"2025-02-10",{"date":332,"type":43},"2023-08-21",{"date":334,"type":20},"2025-12-31",{"name":336,"class":50},"University of Rochester",{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":62,"phases":347,"briefSummary":348,"conditions":349,"keywords":350,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":362},"100530185","phase-2-use-of-elranatamab-in-patients-with-high-risk-smoldering-multiple-myeloma-100530185","NCT06183489","Use of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma","A Multi-center, Open-label, Phase 2 Study of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma","ERASMM","Inclusion Criteria:\n\n1. \\>18 years of age\n2. Diagnosis of SMM for ≤5 years with measurable disease, defined as serum M protein:\n\n   ≥1g\u002FdL or urine M protein ≥200 mg\u002F24 hours or involved serum FLC ≥100 mg\u002FLand abnormal serum FLC ratio.\n3. BMPCs ≥10% and \\\u003C60%\n4. Presence of at least 2 high risk factors, including\n\n   1. Serum M protein ≥2 g\u002FdL,\n   2. BMPC \\>20%\n   3. Serum involved\u002Funinvolved FLC ratio \\> 20\n5. ECOG performance status score of 0 or 1\n6. Subjects must meet the following laboratory parameters, per laboratory reference range (performed at most 15 days before cycle 1 day 1)\n\n   1. Absolute neutrophil count ≥1.0 x 109\u002FL (ie, ≥1000\u002FμL)\n   2. Platelet count ≥75 x 109\u002FL\n   3. Aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN)\n   4. Alanine aminotransferase (ALT) ≤2.5 x ULN\n   5. Total bilirubin ≤1.5 x ULN, except in subjects with congenital bilirubinemia,such as Gilbert syndrome (in which case direct bilirubin ≤2.0 x ULN is required)\n7. Subject must sign an informed consent form (ICF) or their legally acceptable representative must sign indicating that he or she understands the purpose of, and procedures required for the study and is willing to participate in the study.\n8. Women of childbearing potential must have a negative serum or urine pregnancy test at screening and before starting study drug. They must commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control (One highly effective method and one additional effective method) used at the same time, and continuing for at least 5 months after the last dose of Elranatamab. Women must also agree to notify pregnancy during the study.\n\nExclusion Criteria:\n\n1. Previous therapy with any systemic therapy for multiple myeloma.\n2. Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement):\n\n   1. Increased calcium levels: Corrected serum calcium \\>1 mg\u002FdL above the ULN or \\>11 mg\u002FdL\n   2. Renal insufficiency: Determined by glomerular filtration rate (GFR) \\\u003C40 mL\u002Fmin\u002F1.73 m² (Modification of Diet in Renal Disease \\[MDRD\\] Formula) or serum creatinine \\>2 mg\u002FdL\n   3. Anemia (hemoglobin 2 g\u002FdL below lower limit of normal or \\\u003C10 g\u002FdL or both) transfusion support or concurrent treatment with erythropoietin stimulating agents is not permitted\n   4. ≥ 1 bone lytic lesion\n   5. BMPCs ≥60%\n   6. Serum involved\u002Funinvolved FLC ratio ≥100 and an involved FLC ≥100mg\u002FL\n   7. Whole body magnetic resonance imaging (WB-MRI) or positron emission tomography-computed tomography (PET-CT) with more than 1 bone focal lesion (≥5 mm in diameter)\n3. Diagnosis of primary amyloidosis, POEMS syndrome, monoclonal gammopathy of undetermined significance, symptomatic multiple myeloma, or solitary plasmacytoma.\n4. Subject has a diagnosis of Waldenström's macroglobulinemia, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.\n5. Subject has had plasmapheresis within 14 days of elegibility confirmation.\n6. Myocardial infarction within 6 months prior to enrolment according to NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities\n7. Ongoing Grade 2 or higher peripheral sensory\u002Fmotor peripheral neuropathy (PN), history of GBS or GBS variants, or history of grade 3 or higher peripheral motor polyneuropathy\n8. Subject has had major surgery within 2 weeks before elegibility confirmation or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study.\n9. Clinically relevant active infection or serious co-morbid medical conditions\n10. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer free of disease since 5 years.\n11. Female subject who is pregnant or breast-feeding\n12. Serious medical or psychiatric illness likely to interfere with participation in study\n13. Uncontrolled diabetes mellitus\n14. Known HIV infection; Known active hepatitis B or C viral infection; known active COVID-19\u002FSARS-CoV-2 infection\n15. Live attenuated vaccine administered within 4 weeks of the first dose of study intervention\n16. Ongoing treatment with corticosteroids : dose \\>10mg prednisone etc.\n17. Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision",{"count":346,"type":20},50,[252],"This is a multicenter, single arm, open-label, Phase 2 study in high risk smoldering myeloma patients. The primary objective is to determine the efficacy of Elranatamab in patients with previously untreated high-risk SMM. The key-secondary objective is to determine the safety of Elranatamab in patients with previously untreated high-risk SMM.",[30],[351,352],"high-risk smoldering Multiple Myeloma","Elranatamab","2024-10-16",{"date":355,"type":43},"2024-10-18",{"date":357,"type":43},"2024-05-14",{"date":359,"type":20},"2031-07",{"name":361,"class":190},"Stichting European Myeloma Network",25,{"id":364,"slug":365,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":370,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":78},"100461081","a-cohort-study-of-plasma-cell-disorders-pcds-in-pkufh-100461081","NCT05283993","A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH","A Prospective Cohort Study of Patients With Plasma Cell Disorders (PCDs) in PKUFH","Inclusion Criteria:\n\n1. Patients included are those with confirmed diagnosis of PCDs and hospitalized into Peking University First Hospital (PKUFH)\n2. Patients of plasma cell disorders (PCDs) are recruited. PCDs include monoclonal gammopathy of uncertain significance; smoldering myeloma; multiple myeloma; plasma cell leukemia; amyloidosis; light chain deposition disease; heavy chain deposition disease; Castleman's disease (CD); Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy and Skin changes syndrome; cryoglobulinemia; Monoclonal Gammopathy of Renal Significance (MGRS); Monoclonal gammopathy of neurological significance (MGNS).\n3. Patients are included into this cohort after signing the ICFs.\n\nExclusion Criteria:\n\nSignificant comorbidity may be life-threatening.",true,{"count":199,"type":20},"The primary aim is to establish a prospective cohort of patients with plasma cell disorders (PCDs). All of the hospitalized PCD patients who are willing to sign the informed consent form (ICF) will be included in this study. Clinical characteristics, treatment options and responses will be collected. Peripheral blood, bone marrow aspirate and urine samples before and after the treatment will banked for future research. Our team will focus on the clinical and pathological features of PCDs, the correlation between the minimal residual disease (MRD) status and prognosis, and the role of Tumor Microenvironment (TME) in the pathogenesis and progress of PCDs.",[67,203,204,205,206,207,208,30,179,24,374,375],"Monoclonal Gammopathy of Renal Significance (MGRS)","Monoclonal Gammopathy of Neurological Significance (MGNS)","2022-04-21",{"date":378,"type":43},"2022-04-25",{"date":380,"type":43},"2021-07-01",{"date":382,"type":20},"2030-12-31",{"name":384,"class":50},"Peking University First Hospital"]