About this trial
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
This trial does not accept healthy volunteersQualifiers
Receipt of high-dose melphalan 140-200 mg/m2
Autologous stem cell transplantation recipient
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Olanzapine
DrugSubjects will be randomized to either olanzapine 2.5 mg or 5 mg
Treatment groups
Trial outcomes
Primary outcomes
Complete Response
The primary objective is to compare the percentage of patients achieving chemotherapy-induced nausea and vomiting (CINV) complete response (CR), where CR is defined as no emesis and no more than mild nausea (\</=1 score on a 4-point categorical scale \[0 = none, 1 = mild, 2 = moderate, and 3 = severe\]) during the overall assessment period (defined as the day of chemotherapy through 5 days after chemotherapy).
Secondary outcomes
Complete Protection
Complete protection (CP) defined as no emesis, no more than mild nausea, and no use of breakthrough antiemetic agents
Incidence of patients with no more than minimal sedation
Incidence of patients with no more than minimal nausea
Number of emetic episodes
Sponsors and contacts
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