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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-17

Study Completion Date

2027-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Myeloma Autologous Stem Cell Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Olanzapine 2.5 mg

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

Group Type EXPERIMENTAL

Olanzapine

Intervention Type DRUG

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

Olanzapine 5 mg

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

Group Type ACTIVE_COMPARATOR

Olanzapine

Intervention Type DRUG

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

Interventions

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Olanzapine

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

Intervention Type DRUG

Other Intervention Names

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Zyprexa

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No