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

Last updated: November 20, 2024
Sponsor: Augusta University
Overall Status: Active - Recruiting

Phase

3

Condition

Multiple Myeloma

Vomiting

Lactose Intolerance

Treatment

Olanzapine

Clinical Study ID

NCT06588413
2216424
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Receipt of high-dose melphalan 140-200 mg/m2

  • Autologous stem cell transplantation recipient

Exclusion

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 orplanned during protocol therapy

  • Chronic alcoholism

  • Pregnant

  • Decline or unable to provide informed consent

Study Design

Total Participants: 172
Treatment Group(s): 1
Primary Treatment: Olanzapine
Phase: 3
Study Start date:
September 17, 2024
Estimated Completion Date:
October 31, 2027

Study 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.

Connect with a study center

  • Wellstar MCG

    Augusta, Georgia 30912
    United States

    Active - Recruiting

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