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

Augusta University

Status and phase: Enrolling; Phase 3

Conditions: Autologous Stem Cell Transplantation; Multiple Myeloma

Treatments: Drug: Olanzapine

Study type: Interventional

Funder types: Other

Identifiers

NCT06588413

2216424

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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172 participants in 2 patient groups

Olanzapine 2.5 mg

Experimental group

Description:

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

Treatment:

Drug: Olanzapine

Olanzapine 5 mg

Active Comparator group

Description:

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

Treatment:

Drug: Olanzapine