A Phase II Trial of Sunitinib (SU11248) in Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- The Number of Confirmed Responses (Complete Response [CR], Very Good Partial Response [VGPR], or Partial Response [PR])
研究概览
简要总结
This phase II trial is studying how well sunitinib works in treating patients with relapsed multiple myeloma. Sunitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer
详细描述
PRIMARY OBJECTIVES:
I. To assess the number of responses in patients with relapsed multiple myeloma treated with sunitinib (sunitinib malate).
SECONDARY OBJECTIVES:
I. To assess the toxicity of sunitinib malate in patients with relapsed multiple myeloma.
II. To assess time to progression after initial response to sunitinib malate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosis of relapsed multiple myeloma
- •Measurable disease as defined by at least one of the following:
- •Serum monoclonal protein ≥ 1.0 g by protein electrophoresis
- •Urine monoclonal protein > 200 mg by 24-hour electrophoresis
- •Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
- •Monoclonal bone marrow plasmacytosis ≥ 30%
- •Not a candidate for stem cell transplantation OR have undergone prior stem cell collection
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Life expectancy ≥ 3 months
- •Absolute neutrophil count ≥ 1,000/microliter (mcL)
- •Platelets ≥ 75,000/mcL
- •Hemoglobin ≥ 8 g/dL
- •Total serum bilirubin normal
- •aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal
- •Creatinine < 2.5 mg/dL
- •Negative pregnancy test for women of childbearing potential
- •No more than 4 prior therapies
- •Stem cell transplantation and preceding induction therapy will be considered 1 therapy
- •Prior anthracycline exposure or central thoracic radiotherapy that included the heart in the radiotherapy port allowed provided patient has a New York Heart Association (NYHA) class II or better cardiac function on baseline ECHO or multiple gated acquisition scan (MUGA)
- •Concurrent bisphosphonates allowed
- •At least 7 days since prior and no concurrent cytochrome P450 3A4 (CYP3A4) inhibitors
- •At least 12 days since prior and no concurrent CYP3A4 inducers
排除标准
- •Pregnant or nursing women
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib malate
- •History of serious ventricular arrhythmia or corrected QT interval (QTc) prolongation
- •Poorly controlled hypertension
- •Any condition that impairs the ability to swallow and retain sunitinib malate tablets
- •Patients with a preexisting thyroid abnormality who are unable to maintain thyroid function in the normal range with medication
- •Other active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix or breast
- •Concurrent uncontrolled illness including, but not limited to, ongoing or active infections or psychiatric illness/social situations that would limit compliance with study requirements
- •Patients who have not recovered from adverse events of prior therapy
- •Chemotherapy or radiotherapy ≤ 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study entry
- •Any major surgery ≤ 4 weeks prior to study entry
- •Nonmyelosuppressive agents ≤ 2 weeks prior to study entry
- •Any other prior antiangiogenic agents
- •Concurrent high-dose corticosteroids
- •Concurrent chronic steroids (up to 20 mg/day prednisone equivalent) allowed for disorders other than amyloid; NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
- •Concurrent therapeutic doses of coumarin-derivative anticoagulants
- •Concurrent agents with proarrhythmic potential
- •Concurrent combination antiretroviral therapy for HIV-positive patients
- •Any other concurrent investigational agents or anticancer therapy
研究组 & 干预措施
Treatment (kinase inhibitor therapy)
Patients receive 37.5 mg oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
干预措施: sunitinib malate (Drug)
结局指标
主要结局
The Number of Confirmed Responses (Complete Response [CR], Very Good Partial Response [VGPR], or Partial Response [PR])
时间窗: Every 6 weeks from the first initiation of therapy up to 72 weeks
A confirmed response is defined as a patient who has achieved response and maintained it on two consecutive evaluations at least 2 weeks apart. A Complete Response (CR) is defined as the complete disappearance of an M-protein and fewer than 5% bone marrow plasmacytosis. A Hematologic Very good partial response (VGPR) is defined as having a ≥ 90% reduction of M-protein from serum, a Urine M-spike to be ≤ 100 mg/24 hours, and a disappearance of soft tissue plasmacytomas. A Partial Response (PR) is defined as having a 50-89% reduction in the level of the serum monoclonal protein, a reduction in 24-hour urinary light chain excretion either by ≥90% or to \<200 mg, and a ≥ 50% reduction in size of soft tissue plasmacytoma.
次要结局
- Duration of Response(From the documentation of response until the date of progression)
- Event-free Survival(Time from registration to progression or death due to any cause, assessed up to 3 years)
- Toxicity(From the time of first treatment to up to 30 days after the last day of study drug treatment)