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Recruiting Phase 3 NCT06588413

Olanzapine 2.5 vs 5 mg in Quadruplet Nausea/Vomiting Prophylaxis Before High-Dose Melphalan

Trial Parameters

Condition Multiple Myeloma
Sponsor Augusta University
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 172
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-09-17
Completion 2027-10
Interventions
Olanzapine

Brief Summary

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.

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

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