A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 77
- 试验地点
- 22
- 主要终点
- Assess the efficacy of both carfilzomib + study drug and single-agent carfilzomib in terms of progression-free survival.
研究概览
简要总结
This is a Phase 2 study during which patients with advanced multiple myeloma will receive either carfilzomib alone (single-agent) or carfilzomib in combination with investigational study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of both single-agent carfilzomib and carfilzomib + filanesib in treating myeloma. Patients will be allowed to crossover from single-agent carfilzomib to carfilzomib + filanesib if disease progression occurs. Approximately 75 patients from the US will be enrolled in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Confirmed multiple myeloma with measurable disease.
- •Disease refractory to last myeloma regimen.
- •Patients must have received at least 2 prior treatment regimens, including bortezomib and an IMiD (e.g., lenalidomide, thalidomide, pomalidomide). Induction therapy and stem cell transplant ± maintenance are to be considered as a single regimen.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to first dose of study treatment.
- •Adequate hematology, liver and renal function laboratory values within 14 days prior to first dose of study treatment.
- •Additional criteria exist.
排除标准
- •Prior treatment with carfilzomib, filanesib, or any other KSP inhibitor.
- •Past or current plasma cell leukemia.
- •Primary amyloidosis (amyloidosis associated with multiple myeloma is allowed).
- •POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes).
- •Ongoing Grade 3 or Grade 4 peripheral neuropathy, or Grade 2 peripheral neuropathy with pain despite appropriate interventions, within 28 days prior to first dose of study treatment.
- •Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to first dose of study treatment.
- •Concomitant malignancies or previous malignancies (other than multiple myeloma) with less than a 2-year disease-free interval at the time of first dose of study treatment. Patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or Stage 1 prostate cancer are eligible irrespective of the time of diagnosis.
- •Known pulmonary hypertension of any severity.
- •Concurrent cardiac disease that, in the judgment of the Investigator, would make the patient inappropriate for study participation.
- •Known positive serology for the human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C.
- •Acute active infection requiring treatment.
- •Additional criteria exist.
研究组 & 干预措施
Carfilzomib + Filanesib
Single agent + Carfilzomib arm.
Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information.
Filgrastim to be administered per the approved product prescribing information and institutional guidelines.
干预措施: Carfilzomib, proteasome inhibitor; intravenous (Drug)
Carfilzomib + Filanesib
Single agent + Carfilzomib arm.
Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information.
Filgrastim to be administered per the approved product prescribing information and institutional guidelines.
干预措施: Filanesib, KSP(Eg5) inhibitor; intravenous (Drug)
Carfilzomib + Filanesib
Single agent + Carfilzomib arm.
Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information.
Filgrastim to be administered per the approved product prescribing information and institutional guidelines.
干预措施: Dexamethasone, steroid; oral or intravenous (Drug)
Carfilzomib + Filanesib
Single agent + Carfilzomib arm.
Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information.
Filgrastim to be administered per the approved product prescribing information and institutional guidelines.
干预措施: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous (Drug)
Carfilzomib
Single agent arm.
Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information.
干预措施: Carfilzomib, proteasome inhibitor; intravenous (Drug)
Carfilzomib
Single agent arm.
Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information.
干预措施: Dexamethasone, steroid; oral or intravenous (Drug)
结局指标
主要结局
Assess the efficacy of both carfilzomib + study drug and single-agent carfilzomib in terms of progression-free survival.
时间窗: 18 months
次要结局
- Following crossover from single-agent carfilzomib, assess the efficacy of carfilzomib + study drug in terms of objective response rate.(18 months)
- Assess the efficacy of both carfilzomib + study drug and single-agent carfilzomib in terms of objective response rate.(18 months)
- Characterize the pharmacokinetics (PK) of study drug, carfilzomib and a carfilzomib metabolite in patients treated with carfilzomib + study drug in terms of plasma concentration-time profiles and model-based PK parameters.(6 months)
- Assess the safety of both carfilzomib + study drug and single-agent carfilzomib in terms of adverse events, clinical laboratory tests and electrocardiograms.(18 months)
- Following crossover from single-agent carfilzomib, assess the safety of carfilzomib + study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.(18 months)