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.
This study is a randomized, double-blinded trial comparing olanzapine 2.5 mg vs 5 mg in combination with standard triplet antiemetic prophylaxis in patients with multiple myeloma who are receiving high-dose melphalan conditioning chemotherapy before autologous stem cell transplantation to determine chemotherapy-induced nausea and vomiting (CINV) and sedation outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
172
Subjects will be randomized to either olanzapine 2.5 mg or 5 mg
Wellstar MCG
Augusta, Georgia, United States
RECRUITINGComplete 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).
Time frame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
Complete Protection
Complete protection (CP) defined as no emesis, no more than mild nausea, and no use of breakthrough antiemetic agents
Time frame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
Incidence of patients with no more than minimal sedation
Time frame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
Incidence of patients with no more than minimal nausea
Time frame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
Number of emetic episodes
Time frame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
Number of breakthrough antiemetic doses
Time frame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
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