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

RECRUITINGPhase 3Sponsored by Augusta University
Actively Recruiting
PhasePhase 3
SponsorAugusta University
Started2024-09-17
Est. completion2027-10
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

Autologous Stem Cell TransplantationCancerMultiple Myeloma

Locations1 site

Wellstar MCG
Augusta, Georgia, 30912
Amber Clemmons, PharmD706-721-6493aclemmons@augusta.edu

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