[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100295579":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":33,"studyPopulation":34,"armGroups":35,"interventions":44,"overallOfficials":50,"centralContacts":57,"locations":63,"responsibleParty":81,"collaborators":83,"id":86,"slug":29,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":29,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":29,"maxAge":29,"enrollmentInfo":93,"targetDuration":29,"studyType":96,"phases":29,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":65,"whyStopped":29,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Center for International Blood and Marrow Transplant Research","NETWORK",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Compare five-year survival","Compare five-year overall survival between the alloHCT cohort and an age and disease risk matched cohort of autoHCT patients","5 years post transplant",[14,17,20,23,26],{"measure":15,"description":16,"timeFrame":12},"Progression-free survival (PFS)","five-year PFS probabilities between the AlloHCT cohort and an age and disease risk matched cohort of autoHCT patients",{"measure":18,"description":19,"timeFrame":12},"Relapse or progression","Myeloma recurrence or progression will be defined per International Myeloma Working Group (IMWG) guidelines",{"measure":21,"description":22,"timeFrame":12},"Transplant related mortality","Death from any cause within 28 days after alloHCT or death in the absence of progression\u002Frelapse of MM after day 28 post transplant",{"measure":24,"description":25,"timeFrame":12},"Incidence of acute GVHD","Occurrence of Grade I, II and III\u002FIV skin, gastrointestinal, or liver abnormalities fulfilling the Consensus criteria of Grades II-IV acute GVHD",{"measure":27,"description":28,"timeFrame":12},"Incidence of chronic GVHD","Occurrence of symptoms in any organ system fulfilling the criteria of chronic GVHD",null,{"allocation":29,"interventionModel":29,"interventionModelDescription":29,"primaryPurpose":29,"observationalModel":31,"timePerspective":32,"maskingInfo":29},"COHORT","PROSPECTIVE","Multiple myeloma (MM) is the second most common hematologic malignancy in adults. Overall survival (OS) in MM has improved significantly in the last 15 years with the emergence of novel therapies such as thalidomide, bortezomib and lenalidomide. The median life expectancy of patients with MM treated in the current era is more than 6 years, while SEER data from a slightly earlier time period (2008-12) estimated the 5 year survival at 48.5%. However, prognosis is not uniform and varies considerably based on a presenting features and response to therapy.\n\nThe current standard of care for MM patients fit to undergo high dose conditioning chemotherapy is an autologous HCT (autoHCT). There is controversy regarding the timing of autoHCT after initial novel therapy induction with randomized trials showing similar OS whether done early or delayed to time of relapse as salvage therapy. However, more recent trials comparing early versus delayed transplant support the benefit of early upfront autoHCT.\n\nAllogeneic HCT (alloHCT) is the only potentially curative therapy available to patients with MM. However, the significant morbidity and mortality of this procedure historically limited its application in older patients. Current data from the Center for International Blood and Marrow Research (CIBMTR) show transplant-related mortality rates of 23 (20-26)% at 5 years with myeloablative conditioning.\n\nThus, although potentially curative, standard risk MM patients have excellent prognoses in the era of novel therapies which reduces the overall benefit of alloHCT. However, because the outcomes for high-risk MM remain poor despite the best available standard therapies (overall survival of 24-36 months), initial data suggest that alloHCT should be explored in this subset.","A prospective cohort study of approximately 544 patients receiving allogeneic HCT for multiple myeloma in CIBMTR centers in the US matched to a historical control patients treated with autoHCT between 2010 and 2016",[36,41],{"label":37,"type":29,"description":38,"interventionNames":39},"Allogeneic HCT","Prospectively enrolled cohort of patients receiving allogeneic hematopoietic cell transplantation for multiple myeloma",[40],"Other: Allogeneic Hematopoietic Stem Cell Transplant",{"label":42,"type":29,"description":43,"interventionNames":29},"Historical autoHCT","Historical cohort of patients with autologous hematopoietic cell transplantation between 2010 and 2016",[45],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":29},"OTHER","Allogeneic Hematopoietic Stem Cell Transplant","This observational study will compare outcomes of prospectively enrolled HCT recipients with outcomes of a cohort of matched autoHCT controls.",[37],[51,55],{"name":52,"affiliation":53,"role":54},"Anita D'Souza, MD, MS","CIBMTR, Medical College of Wisconsin","STUDY_CHAIR",{"name":56,"affiliation":53,"role":54},"Parameswaran Hari, MD, MS",[58],{"name":59,"role":60,"phone":61,"phoneExt":29,"email":62},"Mona Patel","CONTACT","414-805-0655","mopatel@mcw.edu",[64],{"facility":5,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"RECRUITING","Minneapolis","Minnesota","55401","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-93.26384,44.97997,{"lat":75,"lon":74},[78],{"name":79,"role":60,"phone":29,"phoneExt":29,"email":80},"Michael Tierney","DatabaseIRB@NMDP.org",{"type":82,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[84],{"name":85,"class":46},"National Marrow Donor Program","100295579",false,"NCT03127761","Assessment of Allogeneic Hematopoietic Cell Transplantation in Medicare Beneficiaries With Multiple Myeloma","Assessment of Allogeneic Hematopoietic Cell Transplantation in Medicare Beneficiaries With Multiple Myeloma: A Study to Develop Evidence of Effectiveness for the Centers for Medicare and Medicaid Services (CMS)","Inclusion Criteria:\n\n* Medicare beneficiary\n* Stage II or III multiple myeloma and\u002For primary plasma cell leukemia\n* Eligible to receive an allogeneic HCT from any suitable allogeneic donor (as determined by the transplant center) including umbilical cord blood\n* Will receive allogeneic HCT at a US transplant center\n* Agree to submit comprehensive clinical data on their pre- and post-transplant clinical status and outcomes to the CIBMTR","ALL",{"count":94,"type":95},544,"ESTIMATED","OBSERVATIONAL","Multiple myeloma (MM) is the second most common hematologic malignancy in adults. The current standard of care for MM patients fit to undergo high dose conditioning chemotherapy is an autologous HCT (autoHCT). Allogeneic HCT (alloHCT) is the only potentially curative therapy available to patients with MM. However, the significant morbidity and mortality of this procedure historically limited its application in older patients.\n\nThus, although potentially curative, standard risk MM patients have excellent prognoses in the era of novel therapies which reduces the overall benefit of alloHCT. However, because the outcomes for high-risk MM remain poor despite the best available standard therapies (overall survival of 24-36 months), initial data suggest that alloHCT should be explored in this subset.",[99],"Multiple Myeloma",[99],"2023-08-29",{"date":103,"type":104},"2023-08-30","ACTUAL",{"date":106,"type":104},"2017-07-25",{"date":108,"type":95},"2028-04",{"name":5,"class":6},1]