RecruitingPhase 3NCT06588413

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

Sponsor

Augusta University

Enrollment

172 participants

Start Date

Sep 17, 2024

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma Autologous Stem Cell Transplantation

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two doses of olanzapine (2.5 mg vs 5 mg) for preventing nausea and vomiting in patients receiving very high-dose chemotherapy (high-dose melphalan) before a stem cell transplant. Olanzapine is an antipsychotic medication also used to prevent severe treatment-related nausea. **You may be eligible if...** - You are scheduled to receive high-dose melphalan (140–200 mg/m²) as part of your cancer treatment - You are receiving an autologous stem cell transplant (using your own stem cells) **You may NOT be eligible if...** - You have an allergy to olanzapine - You already had nausea or vomiting in the 24 hours before joining the study - You are currently taking or recently took other antipsychotic medications (risperidone, quetiapine, clozapine, etc.) - You have chronic alcoholism - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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