Phase II Open Lable Clinical Study Efficacy and Safety of the Holistic Treatment for Young Patients With High-Risk Multiple Myeloma
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- progression free survival(PFS)
研究概览
简要总结
The clinical trial was conducted in a cohort of young, high-risk myeloma patients who were designed to receive a combination of high-dose chemotherapy with allogeneic or autologous hematopoietic stem cell transplantation. The objective was to assess the progression free survival (PFS), overall survival (OS),and overall response rate (ORR) of the overall treatment.
详细描述
50 cases of HR-NDMM patients were divided into two groups nonrandomizedly. TE group received hematopoietic stem cell transplantation after induction therapy. Allo-sct for the young patients with suitable donors, Asct for the others. TNE group received consolidation therapy after induction therapy. All patients received PI-based maintenance therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Clinical diagnosis of high-risk multiple myeloma
- •In addition, patients must meet at least one of the following criteria I-IX (I-VIII at time of diagnosis or pre-autograft):
- •I.Complex karyotype
- •II.Fluorescent in situ hybridization (FISH) translocation 4:14 or 14:16,
- •III.FISH translocation 1q21,
- •IV.FISH deletion 17p,
- •V.R-ISS III stage,
- •VI.Two or more high-risk cytogenetic abnormalities exist
- •VII.Plasma cell leukemia
- •VIII.Extramedullary plasmacytoma
- •IX.Recurrent or non-responsive (less than partial remission [PR]) MM after at least 4 cycles of PI/IMids-based chemotherapy
- •candidate for high-dose chemotherapy with stem cell transplantation
- •ECOG performance status score of 0,1,or2 -
排除标准
- •The current diagnosis of smoldering multiple myeloma, monoclonal gammopathy of undetermined significance of disease, Waldenstr o m macroglobulinemia.
- •during the first 5 years of the study, there were no other malignancies, including basal cell carcinoma or in situ cervical cancer.
- •according to the National Cancer Institute general toxicity criteria (NCI CTC), subjects had peripheral neuropathy of grade 2 or above:
- •were enrolled within 6 months before had a myocardial infarction, or New York Heart Association (NYHA) III or IV heart failure ,uncontrolled angina, uncontrolled severe ventricular arrhythmias or ECG evidence of acute ischemia or conduction system abnormalities and activity the clinical significance of pericardial disease, or cardiac amyloidosis -
研究组 & 干预措施
A:Allogeneic Stem Cell Transplant Group
Fludarabine+Melphalan followed by Allogeneic SCT.
干预措施: Allogeneic Hematopoietic Stem Cell Transplantation (Procedure)
A:Allogeneic Stem Cell Transplant Group
Fludarabine+Melphalan followed by Allogeneic SCT.
干预措施: Melphalan Given IV (Drug)
A:Allogeneic Stem Cell Transplant Group
Fludarabine+Melphalan followed by Allogeneic SCT.
干预措施: Fludarabine Injection (Drug)
A:Allogeneic Stem Cell Transplant Group
Fludarabine+Melphalan followed by Allogeneic SCT.
干预措施: PI and dexamethasone as maintenance therapy (Drug)
B:Autologous Stem Cell Transplant
Melphalan followed by Autologous SCT.
干预措施: Autologous Hematopoietic Stem Cell Transplantation x 1 or x 2 (Procedure)
B:Autologous Stem Cell Transplant
Melphalan followed by Autologous SCT.
干预措施: Melphalan Given IV (Drug)
C:Non-Transplant
Consolidated Chemotherapy for Patients Unable to Receive Transplantation
干预措施: PI and dexamethasone as maintenance therapy (Drug)
B:Autologous Stem Cell Transplant
Melphalan followed by Autologous SCT.
干预措施: PI and dexamethasone as maintenance therapy (Drug)
C:Non-Transplant
Consolidated Chemotherapy for Patients Unable to Receive Transplantation
干预措施: PI+IMids+Dexamethasone as Consolidated Chemotherapy (Drug)
结局指标
主要结局
progression free survival(PFS)
时间窗: 1 Year post-autograft
PFS is defined as the duration from the data of registration to either progressive disease or death, whichever comes first.
次要结局
- Non-relapse Mortality (NRM)(1 year post-allograft)
- overall survival(OS)(1 Year post-autograft)
- Number of Patients Who Had Infections(1 Year post-autograft)
- overall response(ORR)(1 Year post-autograft)
- Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease(1 year post-allograft)
研究者
Qiu Lugui
Chief physician
Institute of Hematology & Blood Diseases Hospital, China