Myeloma X Relapse (Intensive): A Phase III Study to Determine the Role of a Second Autologous Stem Cell Transplant as Consolidation Therapy in Patients With Relapsed Multiple Myeloma Following Prior High-dose Chemotherapy and Autologous Stem Cell Rescue.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 460
- 试验地点
- 53
- 主要终点
- Time to disease progression
研究概览
简要总结
RATIONALE: Giving chemotherapy and bortezomib before a peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and bortezomib. It is not yet known whether high-dose melphalan given together with a second stem cell transplant is more effective than low-dose cyclophosphamide in treating patients with relapsed multiple myeloma.
PURPOSE: This randomized phase III trial is studying giving high-dose melphalan together with a second stem cell transplant to see how well it works compared with low-dose cyclophosphamide in treating patients with relapsed multiple myeloma after chemotherapy.
详细描述
OBJECTIVES:
Primary
- To determine the effect on freedom from disease progression in patients with relapsed multiple myeloma treated with re-induction therapy comprising bortezomib, doxorubicin hydrochloride, and dexamethasone (PAD) followed by a second autologous stem cell transplantation (ASCT) with high-dose melphalan vs low-dose cyclophosphamide consolidation therapy.
Secondary
- To assess the response rate of PAD in patients following a previous autograft.
- To compare the overall response rate of patients following high-dose melphalan chemotherapy and autologous stem cell transplantation with low-dose cyclophosphamide consolidation therapy.
- To assess the overall survival of patients treated with this regimen.
- To assess the safety and toxicity of a second ASCT in these patients.
- To assess the safety and toxicity of PAD in these patients.
- To assess the feasibility of stem cell collection following PAD in these patients.
- To determine the impact of this regimen on pain and quality of life in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive high-dose melphalan IV on day -1 followed by autologous stem cell transplantation (ASCT) on day 0.
干预措施: melphalan (Drug)
Arm I
Patients receive high-dose melphalan IV on day -1 followed by autologous stem cell transplantation (ASCT) on day 0.
干预措施: autologous hematopoietic stem cell transplantation (Procedure)
Arm II
Patients receive low-dose cyclophosphamide IV or orally once a week for 12-20 weeks for a total of 12 courses.
干预措施: cyclophosphamide (Drug)
结局指标
主要结局
Time to disease progression
次要结局
- Response rate to bortezomib, doxorubicin hydrochloride, and dexamethasone (PAD)
- Overall response rate following randomized treatments
- Overall survival
- Progression-free survival
- Toxicity and safety of autologous stem cell transplantation
- Toxicity and safety of weekly cyclophosphamide
- Toxicity and safety of PAD therapy
- Feasibility of stem cell collection
- Pain
- Quality of life