Olanzapine 2.5 vs 5 mg in Quadruplet Nausea/Vomiting Prophylaxis Before High-Dose Melphalan
Recruiting now · Phase 3
Conditions studied: Multiple Myeloma, Autologous Stem Cell Transplantation
In brief
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.
Key facts
- Study ID
- NCT06588413
- Run by
- Augusta University
- People needed
- 172
- Starts
- 2024-09-17
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2024-11-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Receipt of high-dose melphalan 140-200 mg/m2
- Autologous stem cell transplantation recipient
You may not qualify if…
- 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
Where it is running
- Wellstar MCG — Augusta, Georgia, United States (enrolling)
Full record on ClinicalTrials.gov
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