NCT00002878已完成3 期
A PHASE III STUDY OF PSC-833 IN COMBINATION WITH VINCRISTINE, DOXORUBICIN AND DEXAMETHASONE (PSC-833/VAD) VERSUS VAD ALONE IN PATIENTS WITH RELAPSING OR REFRACTORY MULTIPLE MYELOMA
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 40
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Combining PSC 833 with chemotherapy may reduce resistance to the drug, and allow more tumor cells to be killed. It is not yet known whether combination chemotherapy plus PSC 833 is more effective than combination chemotherapy alone in treating patients with relapsed or refractory multiple myeloma.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without PSC 833 in treating patients with relapsed or refractory multiple myeloma.
详细描述
OBJECTIVES:
- Compare the overall survival and objective response rate of patients with relapsed or refractory multiple myeloma treated with vincristine, doxorubicin, and dexamethasone (VAD) with or without PSC 833.
- Compare event free survival and subjective response in patients treated with these regimens.
- Correlate treatment outcome with p-glycoprotein expression.
- Determine whether prognostic factors previously determined to be useful in untreated patients (i.e., plasma cell labeling index and multidrug resistance determined from bone marrow aspirates, serum beta 2-microglobulin and interleukin-6 receptor levels) correlate with objective and subjective response and event-free and overall survival in patients treated with these regimens.
- Compare the toxicity of VAD with or without PSC 833.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by response to prior treatment, prior doxorubicin and/or vincristine, prior autologous peripheral blood stem cell transplantation, and center.
Patients are randomized to 1 of 2 treatment arms:
- Arm I: The first group receives vincristine, doxorubicin, and dexamethasone (VAD). Patients receive higher dose vincristine IV over 96 hours and higher dose doxorubicin IV over 96 hours on days 1-4 and oral dexamethasone daily on days 1-4 and 15-18.
- Arm II: The second group receives VAD plus oral PSC 833. Patients receive oral PSC 833 every 6 hours beginning on day 1 and continuing for 20 doses. Patients receive lower dose vincristine IV over 96 hours and lower dose doxorubicin IV over 96 hours on days 2-5 and oral dexamethasone daily on days 2-5 and 16-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Multiple myeloma of any stage confirmed by:
- •Bone marrow plasmacytosis with at least 10% plasma cells, sheets of plasma cells, or biopsy proven plasmacytosis
- •Myeloma (M) protein in serum and/or urine
- •Measurable disease by at least one of the following:
- •Serum M-component at least 1.0 g/dL by electrophoresis
- •Baseline measurement by nephelometry also, if used to follow response
- •Urine M-protein excretion greater than 200 mg/24 hours by electrophoresis
- •The following are not considered measurable but are followed for response:
- •Lytic bone lesions
- •Bone marrow plasmacytosis
- •Serum beta 2-microglobulin
- •Objective evidence of progression by at least one of the following:
- •Increased serum M-protein (by electrophoresis unless M-spike less than 1.5 g/dL)
- •At least 50% above lowest remission level or by at least 2 g/dL
- •To more than 1.0 g/dL if sole protein indication of relapse
- •Nephelometry may be used instead of electrophoresis
- •Increased urine M-protein
- •To 50% above lowest level OR by 2 g/24 hours
- •To greater than 200 mg/24 hours
- •Definite new lytic bone lesions or at least a 50% increase in size of existing lesions (discussion with ECOG Study Chairman required if sole indication of progression)
- •Increase in serum or urine M-protein by 25% to under 50% (as above) plus one of the following:
- •Serum calcium greater than 12 mg/dL without other cause
- •Hemoglobin decreased by more than 2.0 g/dL not attributed to chemotherapy, interferon therapy, or a myelodysplastic syndrome
- •Less than 11 g/dL in men
- •Less than 10 g/dL in women
- •At least a 50% increase in bone marrow plasmacytosis
- •Failure of prior cytotoxic therapy defined by one of the following:
- •Never responded
- •Relapsed within 2 months of last treatment
- •Relapsed 2-12 months after last treatment following initial response
- •Adequate prior chemotherapy required, e.g.:
- •At least 2 courses of combination chemotherapy (e.g., VBMCP, VBAP, MP)
- •Prior vincristine, doxorubicin, and dexamethasone (VAD) allowed
- •No demonstrated resistance to VAD
- •At least 3 months since prior VAD
- •Cumulative doxorubicin dose no more than 250 mg/m2
- •Prior autologous peripheral blood stem cell transplant allowed if performed prior to development of drug resistance
- •No prior allogeneic transplant
- •No smoldering myeloma, localized plasmacytoma, or monoclonal gammopathy of undetermined significance (MGUS)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 2 months
- •Hematopoietic:
- •Absolute neutrophil count at least 1,000/mm^3
- •Platelet count at least 50,000/mm^3
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •AST less than 1.5 times ULN
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排除标准
- 未提供
研究者
研究点 (40)
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