[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561303":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":28,"locations":34,"responsibleParty":52,"collaborators":27,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":27,"enrollmentInfo":66,"targetDuration":27,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":37,"whyStopped":27,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Augusta University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Olanzapine 2.5 mg","EXPERIMENTAL","Olanzapine 2.5 mg dose to be given on the day of high-dose melphalan and three days after",[13],"Drug: Olanzapine",{"label":15,"type":16,"description":17,"interventionNames":18},"Olanzapine 5 mg","ACTIVE_COMPARATOR","Olanzapine 5 mg dose to be given on the day of high-dose melphalan and three days after",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Olanzapine","Subjects will be randomized to either olanzapine 2.5 mg or 5 mg",[9,15],[26],"Zyprexa",null,[29],{"name":30,"role":31,"phone":32,"phoneExt":27,"email":33},"Amber Clemmons, PharmD, BCOP, FHOPA","CONTACT","706-721-6493","aclemmons@augusta.edu",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Wellstar MCG","RECRUITING","Augusta","Georgia","30912","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-81.97484,33.47097,{"lat":47,"lon":46},[50],{"name":51,"role":31,"phone":32,"phoneExt":27,"email":33},"Amber Clemmons, PharmD",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Amber Clemmons","Professor \u002F Clinical Pharmacy Specialist","100561303","phase-3-olanzapine-25-vs-5-mg-in-quadruplet-nauseavomiting-prophylaxis-before-high-dose-melphalan-100561303",false,"NCT06588413","Olanzapine 2.5 vs 5 mg in Quadruplet Nausea\u002FVomiting Prophylaxis Before High-Dose Melphalan","Randomized, Double-Blind Study of FOND (Fosaprepitant, ONdansetron, Dexamethasone) Plus Either Olanzapine 2.5 mg Versus 5 mg for the Prevention of Chemotherapy Induced Nausea and Vomiting in Patients Receiving High-dose Melphalan Conditioning: The FONDO-LOW Study","FONDO-LOW","Inclusion Criteria:\n\n* Receipt of high-dose melphalan 140-200 mg\u002Fm2\n* Autologous stem cell transplantation recipient\n\nExclusion Criteria:\n\n* Allergy to olanzapine\n* Documented nausea or vomiting within 24 hours prior to enrollment\n* Treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone within 30 days prior to enrollment or planned during protocol therapy\n* Chronic alcoholism\n* Pregnant\n* Decline or unable to provide informed consent","ALL","18 Years",{"count":67,"type":68},172,"ESTIMATED","INTERVENTIONAL",[71],"PHASE3","Patients who receive a chemotherapy called melphalan are at high risk of having nausea and vomiting. A medication called olanzapine has been shown to decrease nausea and vomiting after chemotherapy. A previous research study found the 10 mg dose of olanzapine (combined with 3 standard medications used routinely to prevent nausea\u002Fvomiting) to be effective for patients who received melphalan chemotherapy, but several other studies have shown many patients have a side effect of sleepiness (e.g., sedation) with that dose of the medication. Our study will compare two lower doses of olanzapine (5 mg and 2.5 mg) in combination with the 3 standard medications used to prevent nausea\u002Fvomiting in the patients who receive melphalan chemotherapy to determine which dose is effective in preventing nausea and vomiting with the lowest amount of sleepiness side effect.",[74,75],"Multiple Myeloma","Autologous Stem Cell Transplantation",[77,78,22,79,80],"CINV","Nausea","Melphalan","autologous transplant","2024-11-20",{"date":83,"type":84},"2024-11-22","ACTUAL",{"date":86,"type":84},"2024-09-17",{"date":88,"type":68},"2027-10",{"name":5,"class":6},1]