NCT02237261已完成2 期
Bendamustine, Prednisone and Velcade® for First-line Treatment of Patients With Symptomatic Multiple Myeloma Not Eligible for High-dose Chemotherapy Followed by Autologous Stem Cell Transplantation (BPV).
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
- 46
- 试验地点
- 15
- 主要终点
- Overall Response Rate (ORR) of BPV
研究概览
简要总结
The purpose of this study is to improve efficacy of treatment for patients with newly diagnosed multiple myeloma who are not eligible for high-dose chemotherapy followed by autologous stem cell transplantation by Bendamustin, Bortezomib (Velcade), and Prednisone.
详细描述
- Objectives Primary
-Therapeutic efficacy of BPV regimen for multiple myeloma as evidenced by the overall response defined as partial response (PR) or better
Secondary
- to assess overall survival (OS) and progression-free survival (PFS)
- to determine response duration
- to investigate improvements of renal function
- to evaluate safety and toxicity (with respect to adverse events of CTCAE grade ≧3 and SAEs)
- to analyze the efficacy for genetically defined subgroups of myeloma patients based on iFISH and gene-expression profiling
- Investigational Medicinal Products Bortezomib Bendamustine both in combination with Prednisone
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed multiple myeloma requiring systemic treatment (according to CRAB criteria as specified in the appendix I) with following characteristics: Subject is not a candidate for high-dose chemotherapy and stem cell transplantation due to age, presence of comorbidities likely to have a negative impact on tolerability of HDT-SCT, or subject preference
- •Measurable disease, defined as any quantifiable monoclonal protein value, defined by at least one of the following three measurements (Durie et al., 2006):
- •Serum M-protein ≥ 10g/l
- •Urine light-chain (M-protein) of ≥ 200 mg/24 hours
- •Serum FLC assay: involved FLC level ≥ 10 mg/dl provided sFLC ratio is abnormal
- •Age>18 years
- •WHO performance status 0-3 (WHO=3 is allowed only when related to MM and not to co-morbid conditions) (see appendix III)
- •For women of childbearing potential: negative pregnancy test at inclusion
- •All patients must be willing and capable to use adequate contraception during the complete therapy.
- •All patients must agree to abstain from donating blood while on study
- •Ability to understand character and individual consequences of the clinical trial
- •Written informed consent (must be available before enrolment in the trial)
排除标准
- •Subjects presenting any of the following criteria will not be included in the trial
- •Patient has known hypersensitivity to bortezomib, bendamustine and prednisone or to any of the constituent compounds (incl. boron and mannitol).
- •Systemic AL amyloidosis (except for patients with AL amyloidosis of the skin or the bone marrow)
- •Chemotherapy or radiotherapy during the past 5 years except patients with local radiotherapy in case of local myeloma progression. (Note: patients may have received a cumulative dose of up to 160 mg of dexamethasone or equivalent as emergency therapy within 3 weeks prior to study entry.)
- •Plasma cell leukemia which requires the presence of 20% of plasma cell in peripheral blood leukocytes and at least 2 plasma cells/nl.
- •Severe cardiac dysfunction (NYHA classification III-IV, see appendix III)
- •Significant hepatic dysfunction (serum bilirubin ≥ 2 mg/dl or ASAT and/or ALAT ≥ 2.5 times normal level), unless related to myeloma
- •Patients known to be HIV-positive
- •Patients with active, uncontrolled infections
- •Patients with peripheral neuropathy or neuropathic pain of CTC grade 2 or higher (as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0, see appendix V)
- •Second malignancy during the past 5 years except:
- •Adequately treated basal cell or squamous cell skin cancer, or
- •Carcinoma in situ of the cervix, or
- •Prostate cancer < Gleason score 6 with undetectable prostate-specific antigen (PSA) over 12 months, or
- •Ductal breast carcinoma in situ with full surgical resection (i.e., negative margins), or
- •Similar malignant condition as a.- d. with an expected5-year disease free survival larger than 95%
- •Patients with acute diffuse infiltrative pulmonary and pericardial disease
- •Autoimmune hemolytic anemia with positive Coombs test or immune thrombocytopenia
- •Platelet count < 50 x 109/l (transfusion support within 14 days before the test is not allowed), unless related to myeloma
- •Hemoglobin < 7.5g/dl, unless related to myeloma
- •Absolute neutrophil count (ANC) < 0.75 x 109/l (the use of colony stimulating factors within 14 days before the test is not allowed), unless related to myeloma
- •Pregnancy and lactation
- •Participation in other clinical trials within one month prior to enrolment except for supportive care studies and vaccination studies. (Note: this does not include long-term follow-up periods without active drug treatment of previous studies during the last 6 months).
- •No subject will be allowed to enrol in this trial more than once.
研究组 & 干预措施
Bendamustine, Bortezomib, Prednisone
Experimental
Induction: Bortezomib: 1.3 mg/m2 subcutaneous for 7 days and Bendamustine: 90 mg/m2 intravenous for 2 days and in addition Prednison: : 60 mg/m2 per os for 4 days Consolidation: Bortezomib: 1.3 mg/m2 subcutaneous for 4 days and Bendamustine: 90 mg/m2 intravenous for 2 days and in addition Prednison 60 mg/m2 per os for 4 days
干预措施: Bendamustine, Bortezomib, Prednisone (Drug)
结局指标
主要结局
Overall Response Rate (ORR) of BPV
时间窗: 2 years
ORR is defined as PR or better
次要结局
- Number and percentage of patients achieving a complete response(2 years)
- Progression-free survival (PFS)(2 years)
- Overall survival (OS)(2 years)
- Time-to-progression (TTP)(2 years)
- Duration of response (DOR)(2 years)
- Renal response according to IMWG (CRrenal, PRrenal, MRrenal)(2 years)
- Disease-free survival (DFS)(2 years)
- Toxicity (with respect to adverse events of CTCAE grade ≧3 and SAEs)(2 years)
- Time to objective Response (TOR)(2 years)
- Time to treatment failure (TTF)(2 years)
研究者
Dr. Marc Raab
Marc S. Raab MD, Medical Hospital V (Hematology, Oncology, Rheumatology), Section multiple myeloma
University Hospital Heidelberg
研究点 (15)
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