An Open-Label Study of Bendamustine Combined With Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 13
- 主要终点
- Participants With Dose Limiting Toxicity (DLT)
研究概览
简要总结
The primary objective of this study is to assess the safety and tolerability of bendamustine as combination therapy with bortezomib for patients with relapsed/refractory multiple myeloma (MM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •The patient:
- •has a diagnosis of multiple myeloma.
- •currently has multiple myeloma with measurable disease.
- •must have received at least 1 previous treatment regimen and shows signs of progressive disease at the time of study entry.
- •if a woman of child bearing potential (not surgically sterile or at least 12 months naturally postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
- •if a man, must agree to use an acceptable method of contraception throughout the study and for 90 days after last dose study drug.
- •must have an Eastern Cooperative Oncology Group (ECOG) performance status not greater than
- •must have a life-expectancy of greater than 3 months.
- •must meet specific protocol-related hematological and laboratory criteria within 14 days of enrollment.
排除标准
- •The patient has:
- •had a prior malignancy within the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix).
- •plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes (POEMS) syndrome.
- •plasma cell leukemia.
- •non-measurable multiple myeloma.
- •Common Terminology Criteria for Adverse Events (CTCAE) grade 2 (or greater) peripheral neuropathy within 14 days before enrollment.
- •previously participated in a Cephalon-sponsored clinical study with bendamustine.
- •impaired cardiac function or clinically significant cardiac diseases.
- •undergone major surgery within 4 weeks prior to screening or has not recovered from side effects of such therapy.
- •severe hypercalcemia.
- •other concurrent severe and/or uncontrolled medical or psychiatric conditions.
- •known positivity for human immunodeficiency virus (HIV) or hepatitis B or C.
- •a history of allergic reaction attributable to compounds of similar chemical or biological composition to bendamustine, bortezomib, boron, or mannitol.
- •received chemotherapy within 3 weeks before enrollment, with the exception of nitrosoureas, which should be discontinued at least 6 weeks before enrollment.
- •received corticosteroids (greater than 10 mg/day prednisone or equivalent) within 3 weeks before enrollment.
- •received immunotherapy, antibody, or radiation therapy within 4 weeks before enrollment.
- •a status as a pregnant or lactating woman. Any women becoming pregnant during the study will be withdrawn from the study.
- •a status as a male whose sexual partner is a woman of childbearing potential not using effective birth control.
- •used an investigational drug within 1 month before the screening visit.
研究组 & 干预措施
Bendamustine and Bortezomib
Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles.
干预措施: bendamustine (Drug)
Bendamustine and Bortezomib
Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles.
干预措施: bortezomib (Drug)
结局指标
主要结局
Participants With Dose Limiting Toxicity (DLT)
时间窗: Day 1 - 28
Maximum tolerated dose was the dose that was 1 step lower than the dose where at least one third of patients experienced DLT. A DLT was defined as any of the following occurring during the first cycle: * grade 4 hematologic toxicity without regard for relationship to study drug treatment * thrombocytopenia grade 3 with grade 3 or grade 4 hemorrhage * grade 3 febrile neutropenia * grade 3 or grade 4 nausea and vomiting refractory to anti emetic therapy * any study drug related grade 3 or grade 4 nonhematologic toxicity * any drug related death Toxicity grades (3=severe AE and 4=life-threatening or disabling AE) were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.
次要结局
- Percentage of Participants With An Overall Tumor Response As Assessed By the Investigator(Up to 7.5 months (eight 28-day cycles))
- Participants' Best Tumor Response as Assessed by the Investigator(up to 7.5 months (eight 28-day cycles))
- Kaplan-Meier Estimate for Time to Progression (TTP)(up to 8.6 months)
- Kaplan-Meier Estimate for Progression-Free Survival(up to 23 months)
- Time to the First Response(up to 8.5 months)
- Kaplan-Meier Estimate for Duration of Response(up to 8.5 months)
- Kaplan-Meier Estimate for Overall Survival (OS)(up to 23 months)
- Summary of Participants With Adverse Events (AEs)(up to 8.5 months. Deaths are reported up to 18 months)