A Phase II Study of Bortezomib, Liposomal Doxorubicin, Dexamethasone, and Cyclophosphamide in Patients With Multiple Myeloma Relapsing Within 12 Months of Autologous Stem Cell Transplant
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 130
- 主要终点
- One-year Survival in Patients Treated With This Regimen.
研究概览
简要总结
This phase II trial is studying how well giving bortezomib together with liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide works in treating patients with multiple myeloma that relapsed after autologous stem cell transplant. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide may kill more cancer cells.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the 1-year survival of patients with relapsed multiple myeloma treated with bortezomib, liposomal doxorubicin, dexamethasone, and cyclophosphamide.
SECONDARY OBJECTIVES:
I. To evaluate response rates in patients treated with this regimen.
II. To evaluate the median time to progression in patients treated with this regimen.
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 that was symptomatic at the time of initial diagnosis
- •Must have met the following criteria at one point during the disease course:
- •Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or biopsy-proven plasmacytoma
- •Symptomatic disease at initial diagnosis that prompted the initiation of therapy as well as evidence of end-organ damage at the time of diagnosis, including at least 1 of the following:
- •Hypercalcemia
- •Bone disease (lytic bone lesions or pathologic fracture)
- •Renal dysfunction
- •Disease relapsed < 12 months after autologous stem cell transplantation (SCT)
- •Measurable disease, as defined by the presence of ≥ 1 of the following:
- •Serum M-spike ≥ 1 g/dL
- •Urine M-spike ≥ 200 mg/24 hours
- •Involved free light chain (FLC) ≥ 10 mg/dL (provided the serum FLC is abnormal)
- •Plasma cells ≥ 30%
- •ECOG performance status 0-2
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •At least 14 days since prior palliative and/or localized radiotherapy
- •Left ventricular ejection fraction (LVEF) normal by Echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan
- •Hemoglobin > 8 g/dL
- •Platelet count ≥ 75,000/mm^3 (without transfusion support)
- •Absolute neutrophil count (ANC) ≥ 1,000/mm^3 (without use of growth factors)
- •Creatinine < 2.5 mg/dL
- •Direct bilirubin ≤ 1.5 mg/dL
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal
- •All tests below must be performed within 14 days prior to registration:
- •Serum free light chain assay
- •Kappa free light chain
- •Lambda free light chain
- •Prior malignancy allowed provided it was treated curatively and has not relapsed in 5 years
- •Patients with basal cell skin cancer, in situ cervical cancer, or prostate cancer not requiring therapy are eligible
排除标准
- •Therapy for relapsed disease following SCT
- •Known allergy to bortezomib or anthracyclines
- •Prior allogeneic SCT
- •Peripheral neuropathy ≥ grade 2 according to the Cancer Therapy Evaluation Program (CTEP) active version of the NCI Common Terminology Criteria for Adverse Events (CTCAE)
- •Concurrent uncontrolled illness that would limit study compliance, including the following:
- •Uncontrolled hypertension
- •Symptomatic congestive heart failure
- •Unstable angina
- •Uncontrolled cardiac arrhythmia
- •Uncontrolled psychiatric illness or social situation
- •Active uncontrolled infection
- •Prior doxorubicin hydrochloride exposure > 240 mg/m^2
- •Active, uncontrolled seizure disorder
- •Seizures within the past 6 months
- •Pregnant or nursing
研究组 & 干预措施
Treatment (combination chemotherapy)
Patients receive bortezomib 1.3 mg/m2 subcutaneously on days 1, 8, and 15; liposomal doxorubicin 30 mg/m2 intravenously (IV) over 1 hour on day 4; oral dexamethasone 20mg on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide 750 mg/m2 IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
干预措施: liposomal doxorubicin (Drug)
Treatment (combination chemotherapy)
Patients receive bortezomib 1.3 mg/m2 subcutaneously on days 1, 8, and 15; liposomal doxorubicin 30 mg/m2 intravenously (IV) over 1 hour on day 4; oral dexamethasone 20mg on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide 750 mg/m2 IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
干预措施: bortezomib (Drug)
Treatment (combination chemotherapy)
Patients receive bortezomib 1.3 mg/m2 subcutaneously on days 1, 8, and 15; liposomal doxorubicin 30 mg/m2 intravenously (IV) over 1 hour on day 4; oral dexamethasone 20mg on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide 750 mg/m2 IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
干预措施: dexamethasone (Drug)
Treatment (combination chemotherapy)
Patients receive bortezomib 1.3 mg/m2 subcutaneously on days 1, 8, and 15; liposomal doxorubicin 30 mg/m2 intravenously (IV) over 1 hour on day 4; oral dexamethasone 20mg on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide 750 mg/m2 IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
干预措施: cyclophosphamide (Drug)
结局指标
主要结局
One-year Survival in Patients Treated With This Regimen.
时间窗: Assessed at 1 year
Proportion of patients who are still alive at 1 year after registration.
次要结局
未报告次要终点