[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624759":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":37,"studyPopulation":30,"armGroups":38,"interventions":53,"overallOfficials":74,"centralContacts":78,"locations":87,"responsibleParty":103,"collaborators":105,"id":129,"slug":30,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":30,"eligibilityCriteria":134,"healthyVolunteers":130,"sex":135,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":30,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":89,"whyStopped":30,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"The Affiliated People's Hospital of Ningbo University","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Complete Response (CR)","No vomiting, with or without mild to moderate nausea (scoring 0-7 on the MASCC Antiemesis Tool), and no rescue medication use.","24 to 240 hours after chemotherapy",[14,18,21,24,27],{"measure":15,"description":16,"timeFrame":17},"Major Response (MR)","No vomiting with severe nausea (scoring 8-10 on the MASCC Antiemesis Tool), and no rescue medication use.","0-240 hours after chemotherapy",{"measure":19,"description":20,"timeFrame":17},"Clinical Benefit Response (CBR)","CR+MR.",{"measure":22,"description":23,"timeFrame":17},"Minor Response (MiR)","No more than 1-2 vomiting episodes per day, but vomiting occurring on no more than 3 days during the assessment period, with or without nausea of any severity, with permissible use of rescue medication.",{"measure":25,"description":26,"timeFrame":17},"Treatment Failure (TF)","More than 2 vomiting episodes on any day during the assessment period, or more than 1 vomiting episode per day on 3 or more days during the assessment period.",{"measure":28,"description":29,"timeFrame":17},"Toxic Side Effects","Toxicity and adverse reaction assessment based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0.",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":36,"maskingDescription":30,"whoMasked":30},"NONE","Based on strict inclusion and exclusion criteria, 92 patients with multiple myeloma from 11 hospitals were enrolled. Eligible subjects were randomly assigned in a 1:1 ratio to either the experimental group (FTO regimen) or the control group (FTD regimen).The FTO regimen was administered as follows:Fosaprepitant 150 mg (intravenously every 72 hours starting from the initiation of preconditioning chemotherapy until day +6 after HSCT),Tropisetron 5 mg (intravenously 30 minutes before preconditioning chemotherapy on days -3 to -2),Olanzapine 5 mg (orally once daily at bedtime until day +8 after HSCT, or until the occurrence of an adverse drug event requiring study termination or death, whichever occurred first).The FTD regimen was administered as follows: Fosaprepitant 150 mg (intravenously 30 minutes before chemotherapy on day -3),Tropisetron 5 mg (intravenously 30 minutes before preconditioning chemotherapy on days -3 to -2),Dexamethasone 6 mg (orally 30 minutes before chemotherapy on day -3),and 3.75 mg (orally on days -2 to 0).\n\nThe study compared the complete response (CR) rates of the FTO regimen versus the FTD regimen during the acute phase (preconditioning chemotherapy period and 0-24 hours after chemotherapy) and the overall phase (preconditioning chemotherapy period and 0-240 hours after chemotherapy). It also observed and compared the major response (MR), clinical benefit response (CBR), minor response (MiR), and treatment failure (TF) between the two regimens during the acute, delayed, and overall phases. Additionally, the toxic side effects of the FTO and FTD regimens were observed and compared.",[39,47],{"label":40,"type":41,"description":42,"interventionNames":43},"FTO regimen","EXPERIMENTAL","Fosaprepitant, Tropisetron and Olanzapine.",[44,45,46],"Drug: Fosaprepitant","Drug: Tropisetron","Drug: Olanzapine",{"label":48,"type":49,"description":50,"interventionNames":51},"FTD regimen","ACTIVE_COMPARATOR","Fosaprepitant, Tropisetron and Dexamethasone.",[44,45,52],"Drug: Dexamethasone",[54,59,62,66,70],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":30},"DRUG","Fosaprepitant","150mg, intravenously every 72 hours from the initiation of preconditioning chemotherapy until day +6 after HSCT",[40],{"type":55,"name":56,"description":60,"armGroupLabels":61,"otherNames":30},"150mg, intravenously 30 minutes before chemotherapy on day -3",[48],{"type":55,"name":63,"description":64,"armGroupLabels":65,"otherNames":30},"Tropisetron","5mg, intravenously 30 minutes before preconditioning chemotherapy on days -3 to -2",[48,40],{"type":55,"name":67,"description":68,"armGroupLabels":69,"otherNames":30},"Olanzapine","5mg, orally once daily at bedtime until day +8 after HSCT, or until the occurrence of an adverse drug event requiring study termination or death, whichever occurs first",[40],{"type":55,"name":71,"description":72,"armGroupLabels":73,"otherNames":30},"Dexamethasone","6mg, orally 30 minutes before chemotherapy on day -3; 3.75mg, orally on days -2 to 0",[48],[75],{"name":76,"affiliation":5,"role":77},"Peipei Ye","PRINCIPAL_INVESTIGATOR",[79,83],{"name":76,"role":80,"phone":81,"phoneExt":30,"email":82},"CONTACT","86-13685832706","39612903@qq.com",{"name":84,"role":80,"phone":85,"phoneExt":30,"email":86},"Ying Lu","86-13486090834","814871416@qq.com",[88],{"facility":5,"status":89,"city":90,"state":91,"zip":30,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"RECRUITING","Ningbo","Zhejiang","China","CN",{"type":95,"coordinates":96},"Point",[97,98],121.54945,29.87819,{"lat":98,"lon":97},[101,102],{"name":76,"role":80,"phone":81,"phoneExt":30,"email":82},{"name":84,"role":80,"phone":85,"phoneExt":30,"email":86},{"type":104,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[106,109,111,113,115,117,119,121,123,125,127],{"name":107,"class":108},"Zhejiang University","OTHER",{"name":110,"class":108},"Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University",{"name":112,"class":108},"The Central Hospital of Lishui City",{"name":114,"class":108},"Jinhua Central Hospital",{"name":116,"class":108},"Shaoxing People's Hospital",{"name":118,"class":108},"Shaoxing Second Hospital",{"name":120,"class":108},"Jinhua People's Hospital",{"name":122,"class":108},"Zhejiang Provincial Tongde Hospital",{"name":124,"class":108},"First Affiliated Hospital of Wenzhou Medical University",{"name":126,"class":108},"Dongyang People's Hospital",{"name":128,"class":108},"Taizhou Hospital","100624759",false,"NCT07413809","Prevention of Delayed CINV After Autologous Transplant: Olanzapine-Containing Regimen vs. Dexamethasone-Containing Regimen","A Prospective, Multicenter, Randomized Controlled Trial of Fosaprepitant Combined With Tropisetron and Multi-Day Olanzapine Versus Fosaprepitant Combined With Tropisetron and Dexamethasone for the Prevention of Delayed Nausea and Vomiting Induced by High-Dose Chemotherapy in Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Patients with multiple myeloma who are indicated for autologous hematopoietic stem cell transplantation;\n* Preconditioning regimen consists of melphalan at a dose of 200 mg\u002Fm²;\n* ECOG performance status score of 0 to 2;\n* Age \\>18 years and \\\u003C65 years;\n* Expected survival time \\>3 months;\n* Absence of intracranial hypertension, gastrointestinal obstruction, or other causes of refractory vomiting;\n* Ability to understand and provide written informed consent.\n\nExclusion Criteria:\n\n* Presence of nausea or vomiting within 48 hours prior to enrollment, with prior use of antiemetic medications;\n* Current use or use within the past month of CYP3A4 inducers, inhibitors, or substrate drugs;\n* History of hypersensitivity to fosaprepitant or olanzapine;\n* Serum creatinine clearance \\\u003C60 mL\u002Fmin;\n* Inability to receive treatment and follow-up at the designated study site, or inability to comprehend, comply with the study protocol, or provide informed consent.","ALL","18 Years","65 Years",{"count":139,"type":140},92,"ESTIMATED","INTERVENTIONAL",[143],"PHASE3","This study employs a prospective, multicenter, randomized, two-arm design aimed at evaluating the efficacy and safety of the FTO regimen in preventing delayed chemotherapy-induced nausea and vomiting (CINV) following high-dose chemotherapy for hematopoietic stem cell transplantation (HSCT). A total of 92 patients with multiple myeloma who were indicated for autologous HSCT were enrolled. The primary endpoint was to compare the complete response (CR) rates of the FTO regimen versus the FTD regimen in the delayed phase (24-240 hours after chemotherapy) for preventing nausea and vomiting induced by high-dose chemotherapy during HSCT.",[146],"Multiple Myeloma",[148,146,56,67,63],"Delayed vomiting","2026-02-12",{"date":151,"type":152},"2026-02-17","ACTUAL",{"date":154,"type":152},"2025-10-31",{"date":156,"type":140},"2027-09",{"name":5,"class":6},1]