RecruitingPhase 3NCT06588413

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

Randomized, Double-Blind Study of FOND (Fosaprepitant, ONdansetron, Dexamethasone) Plus Either Olanzapine 2.5 mg Versus 5 mg for the Prevention of Chemotherapy Induced Nausea and Vomiting in Patients Receiving High-dose Melphalan Conditioning: The FONDO-LOW Study


Sponsor

Augusta University

Enrollment

172 participants

Start Date

Sep 17, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • Receipt of high-dose melphalan 140-200 mg/m2
  • Autologous stem cell transplantation recipient

Exclusion Criteria6

  • 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

Interventions

DRUGOlanzapine

Subjects will be randomized to either olanzapine 2.5 mg or 5 mg


Locations(1)

Wellstar MCG

Augusta, Georgia, United States

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NCT06588413


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