[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505851":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":12,"centralContacts":26,"locations":32,"responsibleParty":50,"collaborators":52,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":12,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":12,"enrollmentInfo":65,"targetDuration":12,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":35,"whyStopped":12,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"University College Cork","OTHER",[8,13,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Continuation - Group 1: Detectable disease","NO_INTERVENTION","Continuing Maintenance Therapy- Patients with biochemically detectable disease who have failed to achieve Complete remission (CR) or Very good Partial Remission (VGPR) by IMWG criteria and\u002For MRD-positive and\u002For high risk features. They will continue maintenance therapy until disease progression with monitoring every 3 months as per standard of care (SOC), or more often if required. In case of disease progression these patients will be switched to a different treatment and withdraw from the study. QOL will be assessed.",null,{"label":14,"type":10,"description":15,"interventionNames":12},"Continuation - Group 2 Subgroup A: Remission","Continuing Maintenance Therapy- Patients in biochemical remission, who meet IMWG criteria for very good partial response (VGPR) or complete response (CR and and sustained MRD (defined as MRD-negative at two time points that are at least 1 year apart) without high risk features. High-risk cytogenetics abnormalities defined as per IMWG criteria (del(17p) and\u002For t(4;14) and\u002For t(14;16)) , or any other features suggestive of high risk disease: extramedullary disease, poor response to first line therapy, plasma cell leukaemia, organomegaly secondary to infiltration by multiple myeloma.\n\nMaintenance will continue until disease progression, monitored every 3 months as per SOC or more often if required. In case of disease progression these patients will be switched to a different treatment and withdraw from the study. QOL will be assessed.",{"label":17,"type":6,"description":18,"interventionNames":19},"Discontinuation - Group 2 Subgroup B","Patients who prefer to discontinue maintenance therapy. Patients who have discontinued maintenance therapy earlier than 2 years due to side effects but also achieved sustained MRD negative CR might be also included in this subgroup. This subgroup will be monitored and per SOC with blood tests, and BM MRD by NGF. In case of detectable disease in any of the samples (blood or BM) they will be offered to restart on maintenance therapy. Changing to a different type of treatment could be also offered to these patients, after discussion with treating physician. In case of being switched to a different treatment patient will withdraw from the study. QOL will be assessed",[20],"Other: Discontinuation of maintenance treatment",[22],{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":12},"Discontinuation of maintenance treatment","The discontinuation of maintenance treatment in multiple myeloma. Classed as interventional due to treatment being taken away.",[17],[27],{"name":28,"role":29,"phone":30,"phoneExt":12,"email":31},"Dr Vitaliy Mykytiv","CONTACT","00353214922000","vitaliy.mykytiv@hse.ie",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":12,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Cork University Hospital","RECRUITING","Cork","Ireland","IE",{"type":40,"coordinates":41},"Point",[42,43],-8.47061,51.89797,{"lat":43,"lon":42},[46,47],{"name":28,"role":29,"phone":30,"phoneExt":12,"email":31},{"name":48,"role":49,"phone":12,"phoneExt":12,"email":12},"Vitaliy Mykytiv","PRINCIPAL_INVESTIGATOR",{"type":51,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[53],{"name":54,"class":55},"Cancer Research@UCC","UNKNOWN","100505851","discontinuation-study-100505851",false,"NCT05866757","Discontinuation Study","Discontinuation of Maintenance Therapy for the Patients Diagnosed With Multiple Myeloma in Sustainable Minimal Residual Disease (MRD) Negative Remission Without High Risk Features","Inclusion Criteria:\n\n1. 18 years of age or over\n2. Patient with diagnosis of multiple myeloma as per IMWC in first line of treatment (induction, consolidation, ASCT, maintenance is considered single line therapy for the purpose of this study, also discontinuation of 1 maintenance regimen due to toxicity and start of another is considered single line therapy for the purpose of this study).\n3. Received at least 2 years of maintenance therapy, defined as any anti-myeloma therapy to prevent disease recurrence and prolong time in remission\n4. Patients who have discontinued maintenance therapy earlier than 2 years due to side effects but also achieved sustained MRD negative CR might be also included\n5. Patients must be able to understand and be willing to sign a voluntary informed consent form and agree to compliance with the protocol schedule, with the knowledge that they may withdraw consent at any time without impact on future medical care.\n\nExclusion Criteria:\n\n1. Patients who have received more than one line of therapy (induction, consolidation, ASCT, maintenance is considered single line therapy for the purpose of this study, also discontinuation of 1 maintenance regimen due to toxicity and start of another is considered single line therapy for the purpose of this study) or patients who have not completer two years of maintenance therapy, unless maintenance was discontinued voluntarily and the patient has achieved sustainable MRD negative remission..\n2. Patients with plasma cell disorders other than MM: lymphoplasmacytic lymphoma\u002FWaldenstrom macroglobulinemia, AL amyloidosis, POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes), etc…\n3. Prior organ transplant or condition requiring immunosuppressive therapy.\n4. Prior allogenic haematopoietic cell transplant\n5. Treatment with any investigational therapy that does not include maintenance as a part of the treatment strategy.\n6. Unable to sign an informed consent form.","ALL","18 Years",{"count":66,"type":67},70,"ESTIMATED","INTERVENTIONAL",[70],"NA","An interventional, non-randomised study to assess the risk of progression after discontinuation of maintenance therapy in sustained MRD negative complete remission by flow cytometry MM patients without high-risk features who have completed at least two years of maintenance therapy or who have discontinued maintenance due to side effects. The primary endpoint is to assess the rates of sustained MRD negativity by NGF in the bone marrow at 12 months after discontinuation of maintenance therapy.",[73,74,75],"Multiple Myeloma","Cancer","Hematologic Cancer",[73,74],"2026-03-02",{"date":79,"type":80},"2026-03-04","ACTUAL",{"date":82,"type":80},"2023-08-28",{"date":84,"type":67},"2028-07",{"name":5,"class":6},1]