Phase II Trial of Velcade (Bortezomib) in Patients With Previously Untreated Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 6
- 主要终点
- Objective Response (OR) Rate
研究概览
简要总结
Bortezomib (Velcade) has just recently been approved by the FDA for the treatment of multiple myeloma in patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. This study will determine if Velcade is effective in treating patients with multiple myeloma that have had no prior treatment for the disease. We will also use whole-genome scanning to identify drug response biomarkers in bone marrow samples as well as nerve fiber studies to compare nerves prior to the use of Velcade and after treatment with Velcade.
详细描述
Primary Objective
• To evaluate the objective response rate (CR + PR) to bortezomib alone in patients with newly diagnosed multiple myeloma.
Secondary Objectives
- To evaluate the tolerability and toxicity.
- To evaluate time to progression.
- To assess the frequency and severity of peripheral neuropathy.
- To evaluate the impact of early intervention with dose modification and explore symptomatic treatment of peripheral neuropathy.
Exploratory Objectives
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 multiple myeloma based upon standard criteria
- •Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of > 1 g/dl and/or urine monoclonal immunoglobulin spike of > 200mg/24 hours.
- •Karnofsky performance status of > 60
- •Hemoglobin > 8.0 g/dL
- •AST (SGOT) < 3 x ULN
- •ALT < 3 x ULN
- •Total bilirubin < 2 x ULN
- •Is infertile or is practicing an adequate form of contraception
- •18 years of age or older
排除标准
- •Prior treatment with systemic chemotherapy
- •Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes
- •Plasma cell leukemia
- •Calculated or measured creatinine clearance < 30 mL/minute within 14 days of enrollment
- •Grade 2 or greater peripheral neuropathy
- •Hypersensitivity to bortezomib, boron or mannitol
- •Severe hypercalcemia
- •HIV positive
- •Known active hepatitis B or C
- •New York Hospital Association Class III or IV heart failure
- •Second malignancy requiring concurrent treatment
- •Other serious medical or psychiatric illness
- •Pregnant women
- •Dialysis dependent patients
研究组 & 干预措施
bortezomib
Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
干预措施: bortezomib (Drug)
结局指标
主要结局
Objective Response (OR) Rate
时间窗: Response was assessed every two cycles on treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Objective response was defined as complete response (CR) or partial response (PR) according to European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). CR required all of the following: Negative immunofixation on the serum and urine at two consecutive times for minimum 6 weeks; Disappearance of soft tissue plasmacytomas for at least 6 weeks; \<5% plasma cells in bone marrow on 2 determinations for a minimum of 6 weeks; No increase in the size or number of lytic bone lesions. PR required all the following: ≥50% reduction in the level of the serum monoclonal protein on 2 determinations for minimum 6 weeks; If present, reduction in 24-hour urinary light chain excretion either by ≥90% or to \<200 mg on 2 determinations for minimum 6 weeks; ≥50% reduction size of soft tissue plasmacytomas for minimum 6 weeks; No increase in the number or size of lytic bone lesions. Development of a compression fracture does not exclude response in either category.
次要结局
- Very Good Partial Response (VGPR) Rate(Response was assessed every two cycles on treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).)
- Progression-Free Survival (PFS)(Disease was assessed every two cycles on treatment and every 6 weeks in long-term follow-up. Median follow-up was 29 months as of the data analysis.)
- Number of Participants With Treatment-Emergent Neuropathic Pain(Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).)
- Time to Progression (TTP)(Disease was assessed every two cycles on treatment and every 6 weeks in long-term follow-up. Median follow-up was 29 months.)
- Number of Participants With Treatment-Emergent Sensory Neuropathy(Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).)
研究者
Paul G. Richardson, MD
Principle Investigator
Dana-Farber Cancer Institute