Combination High Dose Melphalan and Autologous PBSC Transplant With Bortezomib for Multiple Myeloma: A Dose and Schedule Finding Study
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Safety and Engraftment
研究概览
简要总结
The goal of this study is to evaluate the safety of melphalan and autologous PBSCT (peripheral blood stem cell transplantation - stem cells that come from your own body) in combination with bortezomib, a new FDA approved drug used to treat myeloma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with multiple myeloma who are eligible for an autologous peripheral blood progenitor transplant
- •Male and female subjects between the age of 18 and 70 years.
- •Patient has given informed consent prior to any study related procedures with the knowledge that consent can be withdrawn at anytime without prejudice to future medical care
- •Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements
- •Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- •Male subjects agrees to use an acceptable method for contraception for the duration of the study.
- •Biopsy proven diagnosis of multiple myeloma from bone marrow aspirate and biopsy prior to study initiation
- •Patient has achieved less than 90% disease reduction from previous treatment prior to transplant (as measured by serum or urine protein electrophoresis) and has more than 5% plasma cells in the bone marrow, or patient has progressed and has more than 5% plasma cells in the bone marrow.
- •Karnofsky Performance Status score of ≥ 60%
- •Patient has met the following laboratory requirements prior to Day -4
- •Platelet count ≥ 50, 000/mm3
- •Absolute Neutrophil Count ≥ 500/mm3
- •Hemoglobin ≥ 10 g/dL (transfusion allowed to meet this criterion)
- •Calculated creatinine clearance ≥ 30mL/min
- •Toxic effects of previous therapy or surgery resolved to Grade 2 or better
排除标准
- •Unsupportable anemia with < 10b/dL
- •Patient has a calculated or measured creatinine clearance of < 30mL/min within 14 days before enrollment
- •Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment
- •Patient has hypersensitivity to bortezomib, boron or mannitol
- •Patient has had an allergic reaction to melphalan or chlorambucil
- •Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- •Patient has received other investigational drugs with 14 days before enrollment
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- •Cardiac or pulmonary dysfunction such that patients do not meet institutional pre-transplant evaluation criteria
- •Known central nervous system involvement or suspicion of involvement with Myeloma
- •Other active malignancies (with the exception of basal and squamous cell skin cancer) within 5 years of study entry. Patients with treated prostate or cervical cancer in situ who are 2 or more years from therapy and remain free of disease may be entered into the study at the investigator's discretion.
- •Known to be HIV positive, HIV-1 positive
研究组 & 干预措施
Bortezomib before Melphalan
Enrolled patients were randomized to receive a single escalating dose of bortezomib (1.0, 1.3, or 1.6 mg/m2) 24 hours before melphalan.
干预措施: Bortezomib (Drug)
Bortezomib before Melphalan
Enrolled patients were randomized to receive a single escalating dose of bortezomib (1.0, 1.3, or 1.6 mg/m2) 24 hours before melphalan.
干预措施: Melphalan (Drug)
Bortezomib before Melphalan
Enrolled patients were randomized to receive a single escalating dose of bortezomib (1.0, 1.3, or 1.6 mg/m2) 24 hours before melphalan.
干预措施: Autologous PBSC Transplant (Procedure)
Bortezomib after Melphalan
Enrolled patients were randomized to receive a single escalating dose of bortezomib (1.0, 1.3, or 1.6 mg/m2) 24 hours after melphalan.
干预措施: Bortezomib (Drug)
Bortezomib after Melphalan
Enrolled patients were randomized to receive a single escalating dose of bortezomib (1.0, 1.3, or 1.6 mg/m2) 24 hours after melphalan.
干预措施: Melphalan (Drug)
Bortezomib after Melphalan
Enrolled patients were randomized to receive a single escalating dose of bortezomib (1.0, 1.3, or 1.6 mg/m2) 24 hours after melphalan.
干预措施: Autologous PBSC Transplant (Procedure)
结局指标
主要结局
Safety and Engraftment
时间窗: Day 30 after transplant
Peripheral blood progenitor cells were collected with either chemo-mobilization (27 of 39, 69%) or growth factor mobilization (12 of 39, 31%). Patients received an average of 9.0 × 10\^6/kg CD34+ cells (range, 2.3-65) as their transplant graft.
次要结局
- Response Rate Using EBMT(European Group for Blood and Bone Marrow Transplan) Criteria at Day +100 After Transplant.(100 days after transplant)