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Olanzapine 2.5 vs 5 mg in Quadruplet Nausea/Vomiting 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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Receipt of high-dose melphalan 140-200 mg/m2 * Autologous stem cell transplantation recipient Exclusion Criteria: * Allergy to olanzapine * Documented nausea or vomiting within 24 hours prior to enrollment * Treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone within 30 days prior to enrollment or planned during protocol therapy * Chronic alcoholism * Pregnant * Decline or unable to provide informed consent
About the study
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/vomiting) 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/vomiting 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.
What is being tested
- Olanzapine (drug)
Sponsor: Augusta University · Participants: 172 · Started: Sep 17, 2024
Contact the study team
- Amber Clemmons, PharmD, BCOP, FHOPA · Phone: 706-721-6493
Official record on ClinicalTrials.gov — NCT06588413
Locations in the U.S.
| Georgia | Wellstar MCG, Augusta |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.