Autologous Transplantation for Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 363
- 试验地点
- 1
- 主要终点
- Number of Participants Achieving a Complete Response
研究概览
简要总结
This is a study of a regimen of melphalan and autologous stem cells for patients with multiple myeloma. We hypothesize that this particular regimen will improve the survival of these patients.
详细描述
Before starting treatment in this study, the bone marrow transplant (BMT) doctor will check the subject's general health. Subjects will have the following tests and evaluations to find out if they can participate:--Medical history and physical examination, including height and weight.--Blood tests (approximately 4 - 5 tablespoons) --Urine tests--Chest x-ray--Electrocardiogram (ECG or EKG)--Heart Scan (MUGA)--Pulmonary Function Test (PFT)--Bone marrow biopsies and aspirates. --If Female subjects of child-bearing age will have a serum pregnancy test performed. After eligible patients have been completely staged and exercised consent, they may undergo one cycle of chemotherapy (cyclophosphamide and Mesna) and growth factor (G-CSF) to effect cytoreduction and mobilization of PBSC for collection. All patients will receive high-dose melphalan followed by an autologous stem cell transplant (SCT). Blood tests will be performed frequently to evaluate the subject's response to treatment and possible side effects of treatment. If necessary, platelet and red cell transfusions will be given to maintain adequate levels and antibiotics will be given to treat or prevent infection. Subjects may also require intravenous nutritional support and pain medications during or after transplantation. The study coordinators will collect health information over three years. They will collect information every week for 100 days, then at 6 months, 1 year, 2 years, and 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients meeting the Durie and Salmon criteria for initial diagnosis of multiple myeloma, requiring therapy and meeting one of the following:
- •After initial therapy in either first complete or partial remission or no objective response
- •After achieving initial response and later disease progression, patient will be eligible after subsequent therapy upon achievement of either complete or partial response
- •Is not eligible or has refused any protocols of higher priority
- •18 - 75 years of age
- •Adequate organ function defined as:
- •Hematologic: hemoglobin ≥ 8 gm/dl (untransfused), white blood cells (WBC) ≥ 3000/μl, absolute neutrophil count (ANC) ≥ 1500/μl, platelets ≥ 100,000/μl (untransfused)
- •Cardiac: no active ischemia, left ventricular ejection fraction > 45% by MUGA scan
- •Hepatic: bilirubin < 2.0 mg/dl, ALT < 3x the upper limit of normal
- •Pulmonary: FEV1-Forced Expiratory Volume in One Second AND Forced vital capacity (FVC) >50% predicted and Carbon Monoxide Diffusing Capacity (DLCO) (corrected) > 50% predicted
- •Performance status: Karnofsky performance of > 80%.
- •Free of active uncontrolled infection at the time of study entry.
- •At time of study enrollment > 4 weeks from prior myelosuppressive chemotherapy; and > 6 weeks from prior nitrosoureas.
- •Patients must exercise informed voluntary consent and sign a consent form approved by the University of Minnesota IRB: Human Subjects Committee.
排除标准
- •Patients will be ineligible if they have advanced myeloma refractory and unresponsive to salvage chemotherapy regimens.
- •Female patients who are pregnant (positive b-HCG) or breastfeeding will be excluded from study entry. In addition fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment, particularly after thalidomide will also be excluded from study entry.
研究组 & 干预措施
Chemotherapy and Transplant Treatment
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m^2). Post-transplant maintenance therapy is then prescribed if appropriate.
干预措施: Stem Cell Transplant (Procedure)
Chemotherapy and Transplant Treatment
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m^2). Post-transplant maintenance therapy is then prescribed if appropriate.
干预措施: Cyclophosphamide + Mesna (Drug)
Chemotherapy and Transplant Treatment
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m^2). Post-transplant maintenance therapy is then prescribed if appropriate.
干预措施: Melphalan (Drug)
Chemotherapy and Transplant Treatment
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m^2). Post-transplant maintenance therapy is then prescribed if appropriate.
干预措施: Granulocyte-colony stimulating factor (Biological)
结局指标
主要结局
Number of Participants Achieving a Complete Response
时间窗: 12 months post transplant
Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR: * Normal free light chain ratio * Absence of clonal cells in bone marrow Complete Response (CR): * Absence of the original monoclonal paraprotein * \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy * No increase in size or number of lytic bone lesions * Disappearance of soft tissue plasmacytomas.
次要结局
- Number of Participants With Overall Survival(3 years)
- Number of Patients With Extended Disease-free Survival(36 Months)
- Count of Participants Experiencing Transplant Related Mortality(1 year)
- Number of Participants Experiencing Incidence of Relapse(1 year)
- Number of Participants With Disease Progression(1 year)
- Time to Progression(1 year)
- Time to Relapse(1 year)
- Number of Participants With Absolute Neutrophil Recovery(Day 42)
- Number of Participants With Toxicities(By first 100 days)
- Time to Attainment of CR(12 months post transplant)
- Time to Attainment of CR+PR(12 months post transplant)
- Duration of Maintenance Treatment(During study)
- Dropout Rate From Maintenance Therapy(Post transplant phase)
- Number of Participants With Infections(By first 100 days)