Clinical trial NCT06588413: Olanzapine 2.5 vs 5 mg in Quadruplet Nausea/Vomiting Prophylaxis Before High-Dose Melphalan
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Multiple Myeloma
Autologous Stem Cell Transplantation
Keywords: CINV
Nausea
Olanzapine
Melphalan
autologous transplant
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Complete Response
timeFrame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
Secondary outcomes:
measure: Complete Protection
timeFrame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
measure: Incidence of patients with no more than minimal sedation
timeFrame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
measure: Incidence of patients with no more than minimal nausea
timeFrame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
measure: Number of emetic episodes
timeFrame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
measure: Number of breakthrough antiemetic doses
timeFrame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Wellstar MCG
state: Georgia
Study officials:
References:
citation: 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.
citation: 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.