RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-09-17
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06588413

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Receipt of high-dose melphalan 140-200 mg/m2
  2. * Autologous stem cell transplantation recipient
  1. * Allergy to olanzapine
  2. * Documented nausea or vomiting within 24 hours prior to enrollment
  3. * Treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone within 30 days prior to enrollment or planned during protocol therapy
  4. * Chronic alcoholism
  5. * Pregnant
  6. * Decline or unable to provide informed consent

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Wellstar MCG
Augusta, Georgia, 30912
United States

Collaborators and Investigators

Sponsor: Augusta University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-17
Study Completion Date2027-10

Study Record Updates

Study Start Date2024-09-17
Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

  • CINV
  • Nausea
  • Olanzapine
  • Melphalan
  • autologous transplant

Additional Relevant MeSH Terms

  • Multiple Myeloma
  • Autologous Stem Cell Transplantation