Comparative Study of Dexamethasone vs Prednisone (Both in Combination With Melphalan) as Induction Therapy in Untreated Symptomatic Myeloma With an Additional Assessment of Dexamethasone vs no Additional Treatment as Maintenance Therapy in Non-Progressing Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 595
- 试验地点
- 37
- 主要终点
- Overall survival
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 more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating patients with multiple myeloma.
PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients with multiple myeloma.
详细描述
OBJECTIVES:
- Compare the overall survival of patients with previously untreated stage I-III multiple myelome treated with melphalan combined with dexamethasone or prednisone as induction therapy.
- Compare the overall survival of patients with stable or responding disease after induction treated with dexamethasone vs observation alone as maintenance therapy.
- Compare the time to progression, response rate, and quality of life of patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, stage (I or II vs III), creatinine (less than 2.0 mg/dL vs 2.0 mg/dL or greater), and intention to use prophylactic bisphosphonate (yes vs no).
-
Induction: Patients are randomized to 1 of 4 treatment arms.
-
Arms I and II: Patients receive induction comprising oral prednisone followed by oral melphalan on days 1-4.
-
Arms III and IV: Patients receive induction comprising oral melphalan and oral dexamethasone (DM) on days 1-4 of all courses and DM on days 15-18 of courses 1-3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Melphan plus prednisone
melphalan plus prednisone qd x 4 28 day cycles x 12 cycles; No treatment after stable response.
干预措施: melphalan (Drug)
Melphan plus prednisone
melphalan plus prednisone qd x 4 28 day cycles x 12 cycles; No treatment after stable response.
干预措施: prednisone (Drug)
Melphan, prednisone pluse dexamethasone
melphalan plus prednisone qd x 4 28 day cycles x 12 cycles; dexamethasone qd x 4 q 28 days after non-progression
干预措施: dexamethasone (Drug)
结局指标
主要结局
Overall survival
时间窗: 9 years
To compare overall survival between: i) patients receiving melphalan-prednisone and those receiving melphalan-dexamethasone as induction therapy ii) patients maintained by dexamethasone and those on no additional treatment in the subgroup whose disease has not progressed at the time of the 12th induction cycle
次要结局
- Time to progression(9 years)
- Response rates(9 years)
- Toxicity(9 years)
- Quality of Life(9 years)