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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Complete Response
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receipt of high-dose melphalan 140-200 mg/m2
- •Autologous stem cell transplantation recipient
排除标准
- •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
- •Decline or unable to provide informed consent
研究组 & 干预措施
Olanzapine 2.5 mg
Olanzapine 2.5 mg dose to be given on the day of high-dose melphalan and three days after
干预措施: Olanzapine (Drug)
Olanzapine 5 mg
Olanzapine 5 mg dose to be given on the day of high-dose melphalan and three days after
干预措施: Olanzapine (Drug)
结局指标
主要结局
Complete Response
时间窗: 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).
次要结局
- 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))
研究者
Amber Clemmons
Professor / Clinical Pharmacy Specialist
Augusta University