Autologous Transplantation With High Dose BCNU and Melphalan Followed by Consolidation With DCEP and Taxol/Cisplatin in Patients With Multiple Myeloma and < or = 12 Months of Standard Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
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. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus combination chemotherapy in treating patients who have multiple myeloma.
详细描述
OBJECTIVES: I. Evaluate the complete and partial response in multiple myeloma patients receiving peripheral blood stem cells supported by high dose carmustine and melphalan followed by consolidation therapy with cyclophosphamide/dexamethasone/etoposide/cisplatin (DCEP) and paclitaxel/cisplatin. II. Evaluate the incidence of early death in comparison with historical data in this patient population. III. Evaluate the feasibility of chemotherapy with DCEP and paclitaxel/cisplatin following autotransplantation in these patients.
OUTLINE: Patients receive carmustine IV over 2 hours on day -2, followed by melphalan IV over 20 minutes on day -1. Patients receive intravenous CD34 peripheral blood stem cells on day 0. At 3 months and 9 months, patients with adequate hematologic counts receive cyclophosphamide IV, oral dexamethasone, etoposide IV, and cisplatin IV for 4 days. At 6 and 12 months after autotransplantation, patients with adequate peripheral blood counts and creatinine receive oral dexamethasone on days 1-4, paclitaxel IV over 6 hours on day 2, and cisplatin IV over 24 hours on day 3. Patients are followed every 6 weeks to 3 months until death.
PROJECTED ACCRUAL: Approximately 24-63 patients will be accrued for this study within 2.5 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS: Histologically proven multiple myeloma with no greater than 12 months of prior therapy Bone marrow plasmacytosis at least 30% or protein criteria present No obvious myelodysplastic changes in the bone marrow No CNS disease
- •PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: SWOG 0-2 (3-4 acceptable if based solely on bone pain) Life expectancy: Not specified Hematopoietic: CD34+ at least 4 million/kg Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 4 times upper limit of normal No active chronic hepatitis or liver cirrhosis Renal: Creatinine no greater than 3.0 mg/dL Cardiovascular: LVEF greater than 50% Pulmonary: FEV1 or FVC at least 50% of predicted DLCO at least 50% of predicted Patients unable to complete pulmonary function tests must have a CT scan of the chest and acceptable arterial blood gases of PO2 greater than 70 Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No active infection requiring IV antibiotics
- •PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Prior steroid therapy allowed Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified
排除标准
- 未提供