Multizentrische Therapiestudie Des Multiplen Myeloms DSMM V Therapieoptimierungs-Studie Der Deutschen Studiengruppe Multiples Myelom für Patienten Bis 60 Jahre im Stadium II/III
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 600
- 试验地点
- 29
- 主要终点
- Response rate after high-dose therapy
研究概览
简要总结
The study is evaluating whether risk-stratification by the means of a chromosomal aberration provides a tool to discriminate between standard and high risk. Risk-adapted therapy is based on allogeneic stem-cell transplantation for high-risk subjects instead of a second autograft in patients with deletion of chromosome 13 who have an HLA-identical stem cell donor available.
详细描述
The DSMM V protocol is to compare a consolidation treatment for standard-risk patients not displaying del(13) at initial diagnosis following two cycles of high-dose melphalan 200 mg/m² each supported by autologous stem cell retransfusion with interferon versus PEG-interferon. Patients with del(13) are screened for availability of a fully HLA-matched related or unrelated donor. If patient's informed consent is obtained additionally, he is scheduled to undergo an allogeneic SCT following the first cycle of high-dose melphalan. All other subjects are to proceed to a second course of high-dose melphalan similar to the standard-risk group. Initial cytoreduction is foreseen with four cycles of anthracycline-dexamethasone combination followed by combination therapy with ifosfamide/epirubicine/etoposide for stem-cell collection.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of multiple myeloma
- •Salmon-and-Durie stage II or III
- •Less than or equal to 60 years
- •Signed informed consent
排除标准
- •Relevant comorbidities
- •Unable to adhere to study protocol
- •Pregnancy
- •Not received subject's informed consent
研究组 & 干预措施
Standard risk IFN
Administration of interferon alpha as a maintenance treatment following autologous stem cell transplantation
Standard risk PEGIFN
Maintenance treatment with pegylated interferon following autologous stem cell transplantation
High risk auto
Second cycle of high-dose melphalan in subjects without an HLA-identical donor
High risk allo
Allogeneic stem cell transplantation from an HLA identical related or unrelated donor
干预措施: allogeneic stem cell transplant (Biological)
结局指标
主要结局
Response rate after high-dose therapy
时间窗: one year
次要结局
- Response rate and treatment-related mortality after allogeneic transplantation(one year)