A Phase 2, Open-label, Prospective, Multicenter Study to Evaluate the Efficacy of Intravenous Busulfan and Melphalan as a Conditioning Regimen in Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 入组人数
- 105
- 试验地点
- 8
- 主要终点
- Treatment response up to 2 months after ASCT
研究概览
简要总结
The purpose of this study is to determine whether intravenous busulfan and melphalan as a conditioning regimen is effective in the treatment of multiple myeloma undergoing autologous stem cell transplantation.
详细描述
Title
- A phase 2, open-label, prospective, multicenter study to evaluate the efficacy of intravenous busulfan and melphalan as a conditioning regimen in patients with multiple myeloma (MM) undergoing autologous stem cell transplantation (ASCT)
Principal Investigator
- Je-Jung Lee (Chonnam National University Hwasun Hospital)
Co-investigators
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a confirmed diagnosis of MM
- •Symptomatic MM
- •Age 20 - 65 years
- •The MM patients who performed the stem cell collection with appropriate stem cell counts, cluster of differentiation 34 positive cells more than 2 x 10^6 /kg
- •Eastern Cooperative Oncology Group 0 - 2
- •The MM patients who received induction chemotherapy regardless of types of induction
- •Patient has measurable disease when the patients started the primary induction therapy, defined as follows: Measurable disease is defined as serum M-protein more than 1 g/dL, urine M-protein more than 200 mg/24 hours, or free light chain more than 100 mg/L
- •Adequate liver functions before ASCT Transaminase less than 3 x upper normal value Bilirubin less than 2 x upper normal value
- •Adequate hematological function - Platelet count more than 50,000 /microliter, hemoglobin more than 8 g / dL but, Prior red blood cell transfusion or recombinant human erythropoietin use is allowed, absolute neutrophil count more than 1,000 / microliter
- •Expected survival: 6 months or more
- •Informed consent
排除标准
- •Systemic amyloid light chain amyloidosis, smoldering multiple myeloma or monoclonal gammopathy of undetermined significance
- •Patient with plasma cell leukemia
- •Patients who received an extensive radiation therapy within 4 weeks
- •Patient is known to be Human Immunodeficiency Virus positive
- •Patient has known clinically active Hepatitis B or C
- •Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- •Other serious illness or medical conditions Uncontrolled or severe cardiovascular disease, including myocardial infarction, within 6 months of enrollment, New York Heart Association Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis History of significant neurological or psychiatric disorders including dementia or seizures Active uncontrolled infection Active ulcers detected at gastroscopy Other serious medical illnesses
- •Known hypersensitivity to any of the study drugs or its ingredients concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy
研究组 & 干预措施
BUSULFEX®, Alkeran®
BUSULFEX® 3.2 mg/kg/day iv once daily over 3 hours (day-6~day-4)
Alkeran® 70 mg/m2/day iv once daily over 30 minutes (day-3~day-2)
干预措施: BUSULFEX® (Drug)
BUSULFEX®, Alkeran®
BUSULFEX® 3.2 mg/kg/day iv once daily over 3 hours (day-6~day-4)
Alkeran® 70 mg/m2/day iv once daily over 30 minutes (day-3~day-2)
干预措施: Alkeran® (Drug)
结局指标
主要结局
Treatment response up to 2 months after ASCT
时间窗: 2 months later after last patent received ASCT
1. To evaluate the objective responses after ASCT, the guidelines from the International Myeloma Working (IMW) Group uniform response criteria will be used. 2. Serum free light chain study will be added at the every evaluation of response. 3. To confirm the stringent complete response (sCR) after ASCT, flow cytometry or immunohistochemistry will be used Response Criteria for Multiple Myeloma: the guidelines from the IMW Group uniform response criteria + Add for criteria of near CR (Immunofixation positive CR)
Safety and toxicity (frequency of grade 3 or worse toxicities) of the conditioning regimen
时间窗: 2 months later after last patent received ASCT
NCI Common Toxicity Criteria for Adverse Effects version 4.0 will be used for the examination of toxicities.
次要结局
- Progression free survival(PFS)(2 months later after last patient received ASCT)
- Overall survival (OS)(2 months later after last patient received ASCT)
研究者
Je-Jung Lee
Professor
Chonnam National University Hospital