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

Description

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 Overview

Study Details

Study overview

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.

Randomized, Double-Blind Study of FOND (Fosaprepitant, ONdansetron, Dexamethasone) Plus Either Olanzapine 2.5 mg Versus 5 mg for the Prevention of Chemotherapy Induced Nausea and Vomiting in Patients Receiving High-dose Melphalan Conditioning: The FONDO-LOW Study

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

Condition
Multiple Myeloma
Intervention / Treatment

-

Contacts and Locations

Augusta

Wellstar MCG, Augusta, Georgia, United States, 30912

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Receipt of high-dose melphalan 140-200 mg/m2
  • * Autologous stem cell transplantation recipient
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Augusta University,

Study Record Dates

2027-10