NCT01849848已完成2 期
A Multicenter, Open-Label Phase II Study of SyB L-0501 in Patients With Relapsed/Refractory Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 主要终点
- Response Rate [Stringent CR (sCR)+Complete Response (CR)+Very Good PR (VGPR)+Partial Response (PR)]Based on International Myeloma Working Group (IMWG) Criteria
研究概览
简要总结
The purpose of this study is to determine the antitumor efficacy and safety of bendamustine (SyB L-0501: 90 mg/m^2/day) for a maximum of 6 cycles (1 cycle: intravenous administration for 2 consecutive days and 26-day observation period) in patients with relapsed/refractory multiple myeloma.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are diagnosed with multiple myeloma on the basis of the response criteria of the International Myeloma Working Group (IMWG) and confirmed to meet one or more of the following criteria:
- •(definition of progression according to the IMWG response criteria)
- •25% or more increase compared to baseline for the following values
- •Serum M-protein level (however, the absolute value is 0.5 g/dL or higher)
- •Urine M-protein level (however, absolute value is 200 mg/24 hours or higher)
- •For lesions without measurable serum or urine M-protein values. involved/uninvolved free light chain (FLC) ratio (however, absolute value is 10 mg/dL or higher)
- •Clear appearance of new bone lesions or soft tissue plasmacytoma or apparent growth in size of current bone lesions or soft tissue plasmacytoma
- •Appearance of hypercalcemia (corrected calcium level ≥ 11.5 mg/dL and if determined to be caused solely by myelomas)
- •Patients with measurable lesions (meets at least one of the following two criteria
- •Serum M-protein [Immunoglobulin G (IgG)≥ 1.0 g/dL, Immunoglobulin A (IgA) ≥ 0.5 g/dL, Immunoglobulin D (IgD) ≥ 0.1 g/dL)
- •Urine M-protein ≥ 200 mg/24 hours
- •Patients who meet either one of the following items for all prior chemotherapy using proteasome inhibitors, Immunomodulatory Drugs (IMiDs) (thalidomide or lenalidomide) or alkylating agents.
- •No response*
- •Relapse/recurrence after response*
- •Intolerance
- •Not applicable (reason can be confirmed in the source document) because of predicted aggravation of complications (neurotoxicity, etc.) * Patients whose disease has progressed based on the IMWG response criteria after receiving the most recent therapy
- •Patients who have undergone a washout period of more than 3 weeks after the end of the previous therapy and determined not to be under the effect of previous treatment (antitumor effectiveness).
- •Patients who are expected to survive for at least 3 months
- •Patients aged from 20 to 79 years at the time of interim registration
- •Performance Status (P.S.) of 0 to
- •However, P.S. 2 due to pain from lytic bone lesions is acceptable
- •Patients with adequately maintained organ functions (e.g., bone marrow, heart, lung, liver, and kidney functions)
- •Neutrophil count:≥ 1,500 /mm^3
- •Platelet count:≥ 75,000 /mm^3
- •Albumin:≥ 2.5 g /dL
- •Aspartate aminotransferase (AST) Glutamic oxaloacetic transaminase (GOT): < than 3.0 times the upper limit of normal range for the site
- •Alanine aminotransferase (ALT) Glutamic pyruvic transaminase (GPT): < than 3.0 times the upper limit of normal range for the site
- •Total bilirubin: < than 1.5 times the upper limit of normal range for the site
- •Serum creatinine: < than 3.0 times the upper limit of normal range for the site
- •Partial pressure of O2 (PaO2) ≥ 65 mmHg
- •No abnormalities which require treatment are detected on ECG
- •Left ventricular ejection fraction (LVEF)(echocardiography): ≥ 55%
- •Patients who have provided written consent for participation in this study
排除标准
- •Patients with apparent infections (including viral infections)
- •Patients with serious complications (hepatic or renal dysfunction, etc.)
- •Patients with complications or medical history of serious cardiac disease (e.g., myocardial infarction, ischemic heart disease) within 2 years of the date of interim registration or patients with arrhythmias that require treatment
- •Patients with serious gastrointestinal symptoms (e.g., severe nausea, vomiting, or diarrhea)
- •Patients positive for Hepatitis B surface (HBs) antigen, Hepatitis C virus (HCV) antibody, or HIV antibody
- •Patients with serious bleeding tendencies (e.g., disseminated intravascular coagulation: DIC)
- •Patients with, or confirmed in the past to have had, interstitial pneumonia, pulmonary fibrosis, or pulmonary emphysema which requires treatment.
- •Patients with a complication of apparent cardiac amyloidosis
- •Patients with infiltration to the central nervous system (CNS) or patients with clinical symptoms of suspected infiltration to the CNS,
- •Patients with active multiple primary cancer
- •Patients with, or confirmed in the past to have had, autoimmune hemolytic anemia
- •Patients who have received this investigational product in the past
- •Patients who have received allogeneic stem cell transplants in the past. (patients who have received autologous stem cell transplantation are acceptable)
- •Patients who received cytokine preparations such as erythropoietin or granulocyte colony stimulating factor (G-CSF) or blood transfusions within 1 week prior to the examination conducted before interim registration for this study
- •Patients who received other investigational products or unapproved medications within 3 months before interim registration for this study
- •Patients with prior allergies to medications that are similar to this investigational product (e.g., alkylating agents, or purine-nucleoside derivatives) or mannitol
- •Patients with drug addiction, narcotics addiction, and/or alcohol dependency
- •Patients who are pregnant, who may possibly be pregnant, or lactating
- •Patients who do not agree to practice contraception for the following periods:
- •Male: During investigational product administration and until 6 months after final administration Female: During investigational product administration and until 4 months after final administration
- •Patients otherwise judged by the investigator or sub-investigator to be unsuitable for inclusion in this study
研究组 & 干预措施
SyB L-0501
Experimental
干预措施: SyB L-0501 (Drug)
结局指标
主要结局
Response Rate [Stringent CR (sCR)+Complete Response (CR)+Very Good PR (VGPR)+Partial Response (PR)]Based on International Myeloma Working Group (IMWG) Criteria
时间窗: up to around 44 weeks
The criteria for sCR, CR, VGPR, and PR based on IMWG are shown below. sCR: Fulfills CR criteria as well as all of the following conditions * Normal free light chain (FLC) ratio(κ/λ) * Disappearance of clonal cells in bone marrow by immunohistochemistry or immunofluorescence CR: Fulfills all of the following criteria * Negative immunofixation of serum and urine M-protein * \<5% plasma cells in bone marrow * Disappearance of any soft tissue plasmacytoma VGPR: Fulfills at least one of the following criteria * Serum and urine M-protein detectable by immunofixation but not electrophoresis * ≥90% reduction in serum M-protein and 24-hour M-protein excretion amount in urine \<0.1 g/24 hour PR: Fulfills the following criteria * ≥50% reduction in serum M-protein, and ≥90% reduction in urine M-protein, urine M-protein excretion amount is reduced to \< 0.2 g/24hours
次要结局
- Duration of Response (DOR)(up to around 44 weeks)
- Response Rate (sCR+CR) Based on IMWG Criteria(up to around 44 weeks)
- Complete Response (CR) Based on the Blade Criteria(up to around 44 weeks)
- Response Rate (CR+PR) Based on the Blade Criteria(up to around 44 weeks)
- Progression-Free Survival (PFS)(up to around 44 weeks)
- Adverse Events(up to around 44 weeks)
- Time to Treatment Failure (TTF)(up to around 44 weeks)
- Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values(up to around 44 weeks)
- Overall Survival (OS)(up to around 44 weeks)
- Number of Abnormalities (Grade ≥3) in Laboratory Test Values(up to around 44 weeks)
研究者
相似试验
已完成
2 期
Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell LymphomaNon-Hodgkin's LymphomaMantle Cell LymphomaNCT00612183SymBio Pharmaceuticals56
终止
2 期
Efficacy and Safety Study of SyB L-0501 for Patients With Multiple MyelomaMultiple MyelomaNCT01179490SymBio Pharmaceuticals5
终止
1 期
Bendamustine, Wkly Bortezomib, Lenalidomide and Dexamethasone for Multiple MyelomaMultiple MyelomaNCT01484626Loyola University3
终止
1 期
Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin for Multiple MyelomaMultiple MyelomaNCT01177683Sherif Farag, MB, BS32
Unknown
2 期
Bendamustine Plus Subcutaneous Rituximab in Patients With Diffuse Large B-cell LymphomaDiffuse Large B Cell LymphomaNCT02753062Asan Medical Center22