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NCT Number: NCT06588413

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

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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Key information

Conditions

Multiple Myeloma Autologous Stem Cell Transplantation Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Nausea Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Wellstar MCG

Augusta, Georgia, 30912, United States

Location status: Recruiting

Location contact

Amber Clemmons, PharmD

CONTACT

[email protected]

706-721-6493

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olanzapine

Drug

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

Other names: Zyprexa

Primary outcomes

  1. Complete Response

    Time frame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)

    The primary objective is to compare the percentage of patients achieving chemotherapy-induced nausea and vomiting (CINV) complete response (CR), where CR is defined as no emesis and no more than mild nausea (</=1 score on a 4-point categorical scale [0 = none, 1 = mild, 2 = moderate, and 3 = severe]) during the overall assessment period (defined as the day of chemotherapy through 5 days after chemotherapy).

Secondary outcomes

  1. Complete Protection

    Time frame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)

    Complete protection (CP) defined as no emesis, no more than mild nausea, and no use of breakthrough antiemetic agents

  2. Incidence of patients with no more than minimal sedation

    Time frame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)

  3. Incidence of patients with no more than minimal nausea

    Time frame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)

  4. Number of emetic episodes

    Time frame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)

  5. Number of breakthrough antiemetic doses

    Time frame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)

Study contacts

Contact information is provided by the study sponsor or research team.

Amber Clemmons, PharmD, BCOP, FHOPA

CONTACT

[email protected]

706-721-6493

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Official study 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

Acronym: FONDO-LOW

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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