NCT00088855已完成2 期
Phase II Study of Bortezomib (PS-341) and Pegylated Liposomal Doxorubicin as Initial Therapy for Adult Patients With Symptomatic Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 25
- 主要终点
- CR+nCR rate
研究概览
简要总结
This phase II trial studies the side effects and how well bortezomib and pegylated liposomal doxorubicin hydrochloride work in treating patients multiple myeloma that are experiencing symptoms and have not received prior treatment. Bortezomib and pegylated liposomal doxorubicin hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the complete response (CR) + near-complete response (nCR) rate of the bortezomib/pegylated liposomal doxorubicin (pegylated liposomal doxorubicin hydrochloride) regimen in patients with previously untreated, symptomatic multiple myeloma.
II. To evaluate the toxicity of the bortezomib/pegylated liposomal doxorubicin regimen in patients with previously untreated, symptomatic multiple myeloma.
SECONDARY OBJECTIVES:
I. To evaluate the overall response rate, including patients with CR, nCR, and partial response (PR), of the bortezomib/pegylated liposomal doxorubicin regimen in patients with previously untreated, symptomatic multiple myeloma.
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
- •Patients must have a histologically confirmed diagnosis of symptomatic multiple myeloma with evaluable disease parameters
- •A diagnosis of symptomatic multiple myeloma requires:
- •A monoclonal serum and/or urine protein
- •Clonal bone marrow plasmacytosis, or a histologically confirmed plasmacytoma
- •Related organ or tissue impairment, consisting of:
- •Hypercalcemia (serum calcium > 0.25 mmol/l above the upper limit of normal, or > 2.75 mmol/l [i.e. > 11.5 mg/dl]) AND/OR
- •Renal insufficiency (serum creatinine > 173 mmol/l [i.e., > 2 mg/dL]); (please note that serum creatinine may not be >= 2.5 mg/dL) AND/OR
- •Anemia (hemoglobin 2 g/dl below the lower limit of normal, or hemoglobin < 10 g/dl) AND/OR
- •Bony lesions (lytic bony lesions, or osteoporosis with compression fractures) AND/OR
- •Other findings, such as symptomatic hyperviscosity, amyloidosis, or recurring bacterial infections (> 2 episodes in 12 months)
- •Patients may not have undergone any prior therapy, with the following exceptions:
- •Prior plasmapheresis with plasma exchange (PLEX) for a hyperviscosity syndrome is allowed, providing the patient has no current evidence of hyperviscosity and has not required PLEX for at least one week prior to initiation of therapy
- •Prior radiation therapy to areas of spinal cord compression by plasmacytomas, painful lesions due to bony involvement, or other myeloma-related indications, is allowed provided that radiation will have been completed 3 weeks before initiation of therapy
- •Prior surgical intervention, such as for bony fractures or other myeloma-related complications, is allowed provided that this will have been completed 3 weeks before the initiation of therapy, and patients have recovered from surgery
- •Prior therapy with corticosteroids for indications other than multiple myeloma is allowed, provided such therapy has been discontinued at least two weeks prior to study entry, and at least two weeks before their baseline disease evaluation
- •Prior supportive therapy with bisphosphonates or erythropoietin is allowed
- •Inclusion of females of childbearing potential requires a negative pregnancy test
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- •Patients may not have a prior history of a hypersensitivity reaction to pegylated liposomal doxorubicin or doxorubicin, bortezomib or other boronic acid-based compounds
- •Patients with a history of reactions to liposomal drug formulations other than pegylated liposomal doxorubicin will be evaluated individually, and if their reactions were felt to have been due to the liposomal component itself, as opposed to the encapsulated agent, they will be excluded at the discretion of the investigators
- •Patients who are known to be human immunodeficiency virus (HIV)-seropositive and are taking anti-retrovirals may not participate in this study; patients who are HIV-seropositive and not on anti-retroviral therapy, and who otherwise meet the organ function criteria, will be eligible for the study
- •Patients who are known to have active hepatitis A, B, or C viral infection may not participate in this study
- •No electrocardiogram (EKG) evidence of acute ischemia
- •No EKG evidence of medically significant conduction system abnormalities
- •No history of myocardial infarction within the last 6 months
- •Left ventricular ejection fraction (LVEF) must be >= 45% by either echocardiography or radionuclide-based multiple gated acquisition (radionuclide ventriculography [RNV] or multiple gate acquisition scan [MUGA])
- •No class 3 or class 4 New York Heart Association congestive heart failure
- •Creatinine < 2.5 mg/dL
- •Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) and aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 times the upper limit of the institutional normal value
- •Total bilirubin =< 1.2 times the upper limit of the institutional normal value
- •Absolute neutrophil count (ANC) >= 1,000/ul
- •Platelets >= 100,000/ul
- •Hemoglobin >= 8 g/dl (transfusion- and/or growth factor-dependent patients are not excluded if the above parameters can be achieved with such support)
- •For those patients receiving warfarin (Coumadin), unfractionated heparin, or low-molecular weight heparin therapy, the applicable coagulation parameter that is being monitored must be within the accepted therapeutic ranges for those indications
排除标准
- 未提供
研究组 & 干预措施
Treatment (bortezomib and pegylated liposomal doxorubicin)
Experimental
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 4. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Bortezomib (Drug)
Treatment (bortezomib and pegylated liposomal doxorubicin)
Experimental
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 4. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (bortezomib and pegylated liposomal doxorubicin)
Experimental
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 4. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Pegylated Liposomal Doxorubicin Hydrochloride (Drug)
结局指标
主要结局
CR+nCR rate
时间窗: After 18 weeks (6 courses of treatment)
Will be estimated with an exact 90% confidence interval.
次要结局
- Maximal response rate(After 18 weeks (6 courses of treatment))
- Changes in IL-6 and MIP-1(Baseline to up to day 2 of course 1)
- Incidence of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0(Up to 5 years)
- Progression-free survival(From on-study date to the date of progression or death, whichever comes first, assessed up to 5 years)
- Overall survival(From on-study date to the date of death, assessed up to 5 years)
- CR+nCR+PR rate(After 18 weeks (6 courses of treatment))
研究者
研究点 (25)
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