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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Olanzapine 2.5 mg 		Olanzapine 2.5 mg dose to be given on the day of high-dose melphalan and three days after
  • Drug: Olanzapine
    Subjects will be randomized to either olanzapine 2.5 mg or 5 mg
    Other names:
    • Zyprexa
Active Comparator
Olanzapine 5 mg 		Olanzapine 5 mg dose to be given on the day of high-dose melphalan and three days after
  • Drug: Olanzapine
    Subjects will be randomized to either olanzapine 2.5 mg or 5 mg
    Other names:
    • Zyprexa

Recruiting Locations

Wellstar MCG
Augusta, Georgia 30912
Contact:
Amber Clemmons, PharmD
706-721-6493
aclemmons@augusta.edu

More Details

Status
Recruiting
Sponsor
Augusta University

Study Contact

Amber Clemmons, PharmD, BCOP, FHOPA
706-721-6493
aclemmons@augusta.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.