Efficacy and Safety of Paclitaxel/Cyclophosphamide/Dexamethasone to Treat Patients With Relapsed or Refractory Multiple MyelomaRefractory
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of paclitaxel in combination with cyclophosphamide and dexamethasone in chinese patients with relapsed/refractory multiple myeloma.
详细描述
Treatment for relapsed/refractory multiple myeloma (MM)remains a crucial challenge.The investigators have previously shown that the combination of paclitaxel and cyclophosphamide acts synergistically to induce apoptosis of myeloma cells in vitro. Based on these preclinical studies, the investigators initiated a phase II clinical trial of paclitaxel 175 mg/m(2) IV over 3 h d1 combined with cyclophosphamide 200 mg/m(2) IV over 30-60 min d1,3,5 and dexamethasone 20mg IV over 30-60 min d1-4 in patients with relapsed or refractory MM. This regimen was administered every four weeks for a total of six cycles
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has a previous diagnosis of multiple myeloma
- •Patient requires retreatment for multiple myeloma
- •Subject has measurable disease as defined by > 0.5 g/dL serum monoclonal protein, >10 mg/dL involved serum free light chain (either kappa or lambda) provided that the serum free light chain ratio is abnormal, >0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s) of at least 1cm in greatest dimension as measured by either CT scanning or MRI
- •Subject has a Karnofsky performance status ≥60% (>50% if due to bony involvement of myeloma (see Appendix IV)
- •Subject has a life expectancy ≥ 3 months
- •Subjects must meet the following laboratory parameters:
- •Absolute neutrophil count (ANC) ≥750 cells/mm3 (1.0 x 109/L) Hemoglobin ≥ 7 g/dL Platelet count ≥ 75,000/mm3 (30 x 109/L if extensive bone marrow infiltration) Serum SGOT/AST <3.0 x upper limits of normal (ULN) Serum SGPT/ALT <3.0 x upper limits of normal (ULN) Serum total bilirubin <2.0 mg/dL (34 µmol/L) Creatinine clearance ≥ 45 cc/min
排除标准
- •Subject has immeasurable MM (no measurable monoclonal protein, free light chains in blood or urine, or measureable plasmacytoma on radiologic scanning)
- •Subject has a prior history of other malignancies unless disease-free for ≥ 5 years, except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or localized prostate cancer with Gleason score < 7 with stable prostate specific antigen (PSA) levels
- •Subject has had myocardial infarction within 6 months prior to enrollment, or NYHA (New York Hospital Association) Class III or IV heart failure (see Appendix VI), Ejection Fraction < 35%, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- •Female subject who is pregnant or lactating
- •Subject has known HIV infection
- •Subject has known active hepatitis B or hepatitis C infection
- •Subject has active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program
- •Subject is unable to reliably take oral medications
- •Subject has known hypersensitivity to dexamethasone,cyclophosphamide,paclitaxel
- •Subject has a history of thromboembolic event within the past 4 weeks prior to enrollment
- •Subject has any clinically significant medical or psychiatric disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
研究组 & 干预措施
Intervention
paclitaxel 175 mg/m(2) IV over 3 h d1,cyclophosphamide 200 mg/m(2) IV d1,3,5 and dexamethasone 20mg IV d1-4 in patients with relapsed or refractory MM.
干预措施: Paclitaxel (Drug)
Intervention
paclitaxel 175 mg/m(2) IV over 3 h d1,cyclophosphamide 200 mg/m(2) IV d1,3,5 and dexamethasone 20mg IV d1-4 in patients with relapsed or refractory MM.
干预措施: Cyclophosphamide (Drug)
Intervention
paclitaxel 175 mg/m(2) IV over 3 h d1,cyclophosphamide 200 mg/m(2) IV d1,3,5 and dexamethasone 20mg IV d1-4 in patients with relapsed or refractory MM.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 30 months
ORR is defined as the proportion of patients with CR, nCR or partial response (PR) based on modified EBMT criteria per investigator assessment
次要结局
- Progression Free Survival (PFS)(30 months)
- Overall survival (OS)(30 months)
- Safety of combination therapy assessed using the National Cancer institute-Common Toxicology Criteria (NCI-CTC) grade scale for AEs and Lab assessments(30 months)
研究者
wanghua
professor
Sun Yat-sen University