Recruiting
Phase 3

Olanzapine 2.5 vs. 5 mg

Sponsor:

Augusta University

Code:

NCT06588413

Conditions

Multiple Myeloma

Autologous Stem Cell Transplantation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Olanzapine

Study Details

Brief 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.

Conditions

Multiple Myeloma

Autologous Stem Cell Transplantation

Study ID

NCT06588413

Start date

Sep 17, 2024

Status verified date

Nov, 2024

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

172 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Olanzapine 2.5 mg

Olanzapine 2.5 mg dose to be given on the day of high-dose melphalan and three days after

active comparator: Olanzapine 5 mg

Olanzapine 5 mg dose to be given on the day of high-dose melphalan and three days after

Interventions

Olanzapine

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

Primary outcome measure

  • Complete Response [ Time Frame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase) ]

Central Contacts and Locations

Central contacts

Amber Clemmons, PharmD, BCOP, FHOPA

706-721-6493aclemmons@augusta.edu

Locations

Wellstar MCG

Recruiting

Augusta, Georgia, United States, 30912

Contacts

More Information

Sponsor

Augusta University

Last update posted

Nov 22, 2024

Last verified

Nov, 2024

Keywords

  • CINV
  • Nausea
  • Olanzapine
  • Melphalan
  • autologous transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augusta University on 2024-11-22.