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

NCT06588413 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 2216424
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

CINV; Nausea; Olanzapine; Melphalan; autologous transplant

Outcome Measures

Primary Outcomes (1)

• Complete Response

  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).

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

Secondary Outcomes (5)

• Complete Protection

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

• Incidence of patients with no more than minimal sedation

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

• Incidence of patients with no more than minimal nausea

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

• Number of emetic episodes

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

• Number of breakthrough antiemetic doses

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

Study Arms (2)

Olanzapine 2.5 mg

EXPERIMENTAL

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

Drug: Olanzapine

Olanzapine 5 mg

ACTIVE COMPARATOR

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

Drug: Olanzapine

Interventions

Olanzapine DRUG

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

Also known as: Zyprexa

Olanzapine 2.5 mg; Olanzapine 5 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Wellstar MCG

Augusta, Georgia, 30912, United States

RECRUITING

Related Publications (2)

• Bajpai J, Kapu V, Rath S, Kumar S, Sekar A, Patil P, Siddiqui A, Anne S, Pawar A, Srinivas S, Bhargava P, Gulia S, Noronha V, Joshi A, Prabhash K, Banavali S, Sarin R, Badwe R, Gupta S. Low-dose versus standard-dose olanzapine with triple antiemetic therapy for prevention of highly emetogenic chemotherapy-induced nausea and vomiting in patients with solid tumours: a single-centre, open-label, non-inferiority, randomised, controlled, phase 3 trial. Lancet Oncol. 2024 Feb;25(2):246-254. doi: 10.1016/S1470-2045(23)00628-9. Epub 2024 Jan 12.

  PMID: 38224701 BACKGROUND

• Clemmons AB, Orr J, Andrick B, Gandhi A, Sportes C, DeRemer D. Randomized, Placebo-Controlled, Phase III Trial of Fosaprepitant, Ondansetron, Dexamethasone (FOND) Versus FOND Plus Olanzapine (FOND-O) for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients with Hematologic Malignancies Receiving Highly Emetogenic Chemotherapy and Hematopoietic Cell Transplantation Regimens: The FOND-O Trial. Biol Blood Marrow Transplant. 2018 Oct;24(10):2065-2071. doi: 10.1016/j.bbmt.2018.06.005. Epub 2018 Jun 13.

  PMID: 29906570 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma; Nausea

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Amber Clemmons, PharmD, BCOP, FHOPA

CONTACT

706-721-6493; aclemmons@augusta.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor / Clinical Pharmacy Specialist

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: September 17, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)