Randomized, Double-Blind Study of FOND (Fosaprepitant, Ondansetron, Dexamethasone) Plus Olanzapine 2.5 mg Versus 5 mg for Preventing Chemotherapy-Induced Nausea and Vomiting in High-Dose Melphalan Patients

What this Trial Is About

Researchers are studying patients with multiple myeloma who receive high-dose melphalan chemotherapy before autologous stem cell transplantation. This trial aims to compare two lower doses of olanzapine (2.5 mg and 5 mg), given with three standard anti-nausea medications, to find which dose best prevents nausea and vomiting while causing the least sleepiness side effect. The study is randomized and double-blinded, focusing on chemotherapy-induced nausea, vomiting, and sedation outcomes. Participants will be randomly assigned to receive either 2.5 mg or 5 mg of olanzapine on the day they receive high-dose melphalan and for three days afterward. Both groups will continue to receive the standard three medications routinely used to prevent nausea and vomiting. The study compares these two olanzapine doses as part of quadruplet antiemetic prophylaxis. During the study, participants will be monitored from the day of chemotherapy through five days after for nausea, vomiting, sedation, and the need for additional antiemetic medications. Researchers will use measures such as complete response to nausea/vomiting, protection from nausea, number of vomiting episodes, and sedation levels. The trial includes assessments of these effects to determine the best olanzapine dose. The entire participation period covers the acute and delayed phases of chemotherapy side effects.

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