A Multicenter, Open-Label, Phase 2 Study of SyB L-0501 (Bendamustine Hydrochloride) for Patients With Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Complete Response (CR) Rate [Based on the Modified Southwest Oncology Group (SWOG) Criteria]
研究概览
简要总结
The study objectives of this study are to determine the effects, safety, and pharmacokinetics of bendamustine for multiple myeloma to a regimen of bendamustine and prednisolone.
详细描述
The study objectives of this study are to determine the effects, safety, and pharmacokinetics of bendamustine for untreated and maladjustment to hematopoietic stem cell transplantation (HSCT) multiple myeloma to a regimen of bendamustine and prednisolone.
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 are included in the study if all of the following criteria are met: Patients confirmed to have multiple myeloma (symptomatic myeloma) defined in the diagnostic criteria of the International Myeloma Working Group (IMWG).
- •Patients with measurable lesions
- •Patients with no history of treatment (no history of chemotherapy or radiotherapy)
- •Patients should not be considered candidates for high dose therapy/autologous stem cell transplantation due to coexistent medical conditions, advanced age, poor performance status, refusal of high dose chemotherapy, or other reasons as judged by the patient and/or physician.
- •Expected survival of at least 3 months
- •Patients aged between 20 and 79 years (at the time of provisional registration)
- •Performance status (P.S.) grade 0-
- •P.S. 3 possible only for osteolytic lesions
- •Patients with adequately maintained organ function (e.g., bone marrow, heart, lungs, liver, kidneys,)
- •Patients from whom written consent to participate in this study has been obtained.
排除标准
- •Patients are excluded from participating in the study if 1 or more of the following criteria are met:
- •Patients with apparent infections (including viral infections)
- •Patients with serious complications (hepatic failure, renal failure, or diabetes with insulin administration)
- •Patients with complications or a medical history of serious cardiac disease (e.g., myocardial infarction, ischemic heart disease) within 2 years before preliminary registration. Patients with arrhythmia requiring treatment.
- •Patients with serious gastrointestinal symptoms (profound or serious nausea / vomiting or diarrhea, etc.)
- •Patients who were hepatitis B virus antigen (HBsAG)-positive, hepatitis C virus (HCV) antibody-positive or human immunodeficiency virus (HIV) antibody-positive
- •Patients with a serious bleeding tendency [e.g., Disseminated intravascular coagulation (DIC)]
- •Patients with interstitial pneumonia, pulmonary fibrosis or pulmonary emphysema requiring treatment, or such diseases in the past
- •Patients with apparent amyloidosis as a complication
- •Patients with clinical symptoms of invasion or suspected invasion of the central nervous system.
- •Patients with active multiple cancers
- •Patients who have or previously had autoimmune hemolytic anemia.
- •Patients administered this investigational drug in the past
- •Patients who received hematopoietic stem cell transplantation in the past.
- •Patients who received cytokines such as granulocyte colony stimulating factor (G-CSF) or erythropoietin or a blood transfusion within 1 week before the screening examination prior to preliminary registration for this study
- •Patients who were administered an investigational drug during a clinical study or an unapproved drug within 3 months prior to preliminary registration in this study
- •Patients with prior allergies to medications similar to the investigational drug (e.g., alkylating agents, or purine nucleotide analogs), mannitol or prednisolone
- •Patients with drug addiction, narcotic addiction or alcoholism.
- •Patients who were pregnant, breastfeeding women or who had a possibility to be pregnant
- •Patients who do not agree to contraception during the following periods. For males, during or for 6 months after completion of administration of the investigational drug. For females, during or for 3 months after completion of administration of the investigational drug
- •Patients whom the investigator or the sub-investigators considered to be inappropriate for the study
研究组 & 干预措施
SyB L-0501 + prednisolone
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
干预措施: SyB L-0501 (Drug)
SyB L-0501 + prednisolone
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
干预措施: prednisolone (Drug)
结局指标
主要结局
Complete Response (CR) Rate [Based on the Modified Southwest Oncology Group (SWOG) Criteria]
时间窗: Up to 36 weeks
The proportion of subjects evaluated as CR was calculated. CR (modified SWOG) requires all of the followings: 1. Decline in serum myeloma protein by ≥75% to ≤25 g/L 2. Reduction in 24 h urinary protein by ≥90% to ≤200 mg/24 h 3. No increase in skeletal destruction 4. Serum calcium within normal range 5. No blood transfusion required in the previous 3 months
次要结局
- CR Rate [Based on the International Myeloma Working Group (IMWG) Criteria](Up to 36 weeks)
- Response Rate (Based on the IMWG Criteria)(Up to 36 weeks)
- CR Rate Based on the (Bladé) Criteria(Up to 36 weeks)
- Response Rate (Based on the Bladé Criteria)(Up to 36 weeks)
- Response Rate (Based on the Modified SWOG Criteria)(Up to 36 weeks)
- Progression-Free Survival (PFS)(Up to 2 years)
- Time to Treatment Failure (TTF)(Up to 2 years)
- Duration of Response (DOR)(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
- Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Related Serious Adverse Event(Up to 2 years)
- Number of Adverse Events, Related Adverse Events, Serious Adverse Events, and Related Serious Adverse Events(Up to 2 years)
- Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values(Up to 2 years)
- Number of Abnormalities (Grade ≥3) in Laboratory Test Values(Up to 2 years)
- Pharmacokinetic Parameters (Cmax)(On Day 1 only)
- Pharmacokinetic Parameters (Tmax)(On Day 1 only)
- Pharmacokinetic Parameters (AUC)(On Day 1 only)
- Pharmacokinetic Parameters (t1/2)(On Day 1 only)