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临床试验/NCT00003399
NCT00003399已完成2 期

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

University of Maryland, Baltimore2 个研究点 分布在 1 个国家开始时间: 1998年9月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
试验地点
2

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

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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