Autologous Stem Cell Transplantation, Multiple Myeloma
Conditions
Keywords
CINV, Nausea, Olanzapine, Melphalan, autologous transplant
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.
Detailed description
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.
Interventions
DRUGOlanzapine
Subjects will be randomized to either olanzapine 2.5 mg or 5 mg
Sponsors
Augusta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response | From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase) | 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
| Measure | Time frame | Description |
|---|---|---|
| Complete Protection | From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase) | 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 | From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase) | — |
| Incidence of patients with no more than minimal nausea | From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase) | — |
| Number of emetic episodes | From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase) | — |
| Number of breakthrough antiemetic doses | From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase) | — |
Countries
United States
Contacts
Primary ContactAmber Clemmons, PharmD, BCOP, FHOPA
Outcome results
None listed