NCT00777738已完成2 期
A Phase IIA Trial Testing the Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia
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
- 34
- 试验地点
- 1
- 主要终点
- Complete and partial remission, defined by the 2nd Workshop on Waldenstrom's macroglobulinemia
研究概览
简要总结
This trial is designed to evaluate the efficacy and toxicity of Bortezomib , an inhibitor of proteasome used in multiple myeloma, in patients with advanced Waldenström's Macroglobulinemia disease.
详细描述
Open, prospective, multicenter, non controlled phase IIA trial
Primary objectives Evaluation of the efficacy and safety of Velcade in monotherapy for patients with advanced stage Waldenström Macroglobulinemia.
Secondary objectives Evaluation of the activity of the association of High Dose Dexamethasone (HD DXM) with Velcade for patients resistant to Velcade Alone For all patients
- Overall survival
- Safety
- Quality of life
- Duration of response
sample size: With type I error alpha of 5% and type II error beta of 20% and a two-sided test, the number of patients needed in this study is 34 Number of centers: 28 Centers participating to the French cooperative group CLL/WM
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
- •● Established diagnosis of Waldenström macroglobulinemia (the 2nd Workshop on Waldenstrom's macroglobulinemia)
- •Patient must have had 1 (or 2) lines of chemotherapy containing alkylating agent and/or Fludarabine :and /or monoclonal antibody and must have :
- •Life expectancy > 3 months
- •Age > 18 years
- •ECOG performance status 0-1-2
- •ANC > 1 x 109/L
- •Creatinine clearance, calculated according to the formula of cockcroft and Gault > 40 ml/min
- •Total bilirubin < 2x ULN
- •ASAT, ALAT < 2x ULN
- •A negative serum pregnancy test one week prior to treatment must be available both for pre-menopausal women and for women who are < 2 years after the onset of menopause
- •Adequate contraceptive methods for males and pre-menopausal females for 6 months after treatment discontinuation.
- •Written informed consent
- •Platelets> 100X 109
排除标准
- •Active secondary malignancy or chemotherapy/radiotherapy for any neoplastic disease other than Waldenström macroglobulinemia prior to the study
- •Medical condition requiring the long-term (estimated to be more than one month) use of oral corticosteroids
- •Patients with active bacterial, viral or fungal infection
- •Known infection with HIV, Hepatitis B (except post vaccinal profile) or C
- •Treatment with any, other investigational agent or participating in another trial within 30 days prior to entering this study
- •Lactation/pregnancy
- •Concurrent severe diseases which exclude the administration of therapy heart insufficiency NYHA grade III/IV, LEVF < 50% and or RF < 30%, myocardial infarction within the past 6 months prior to study
- •Severe pulmonary or heart problems (acute diffuse pulmonary and pericardial disease)
- •Severe chronic obstructive lung disease with hypoxemia
- •Severe diabetes mellitus
- •Hypertension difficult to control
- •Impaired renal function with creatinine clearance < 40 ml/min according to the formula of Cockcroft and Gault
- •Cerebral dysfunction
- •Richter's syndrome
- •Neuropathy> grade 1
- •Positive Beta HCG
- •Severe Hepato cellular alteration
研究组 & 干预措施
bortezomib
Experimental
bortezomib
干预措施: BORTEZOMIB (Drug)
结局指标
主要结局
Complete and partial remission, defined by the 2nd Workshop on Waldenstrom's macroglobulinemia
时间窗: 3 months and 6 months
次要结局
- Duration of the response(during the study)
- Overall survival(during the study)
- Quality of life(months 0, 3, 12, 24)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Bortezomib and Combination Chemotherapy in Treating Younger Patients With Recurrent, Refractory, or Secondary Acute Myeloid LeukemiaAdult Acute Monoblastic Leukemia (M5a)Adult Acute Monocytic Leukemia (M5b)Adult Acute Myeloblastic Leukemia With Maturation (M2)Adult Acute Myeloblastic Leukemia Without Maturation (M1)Adult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myelomonocytic Leukemia (M4)Childhood Acute Basophilic LeukemiaChildhood Acute Eosinophilic LeukemiaChildhood Acute Erythroleukemia (M6)Childhood Acute Megakaryocytic Leukemia (M7)Childhood Acute Minimally Differentiated Myeloid Leukemia (M0)Childhood Acute Monoblastic Leukemia (M5a)Childhood Acute Monocytic Leukemia (M5b)Childhood Acute Myeloblastic Leukemia With Maturation (M2)Childhood Acute Myeloblastic Leukemia Without Maturation (M1)Childhood Acute Myelomonocytic Leukemia (M4)Recurrent Adult Acute Myeloid LeukemiaRecurrent Childhood Acute Myeloid LeukemiaSecondary Acute Myeloid LeukemiaNCT00666588National Cancer Institute (NCI)52
Unknown
2 期
Bortezomib and Pegylated Liposomal Doxorubicin in BRCA Wild-type Platinum-resistant Recurrent Ovarian Cancer PatientsOvarian Neoplasm EpithelialHigh Grade Serous CarcinomaNCT03509246Seoul National University Hospital44
已完成
2 期
Bortezomib With or Without Irinotecan in Treating Patients With Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Head and NeckRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityRecurrent Verrucous Carcinoma of the LarynxRecurrent Verrucous Carcinoma of the Oral CavityStage IV Squamous Cell Carcinoma of the HypopharynxStage IV Squamous Cell Carcinoma of the LarynxStage IV Squamous Cell Carcinoma of the NasopharynxStage IV Verrucous Carcinoma of the LarynxStage IVA Squamous Cell Carcinoma of the Lip and Oral CavityStage IVA Squamous Cell Carcinoma of the OropharynxStage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVA Verrucous Carcinoma of the Oral CavityStage IVB Squamous Cell Carcinoma of the Lip and Oral CavityStage IVB Squamous Cell Carcinoma of the OropharynxStage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVB Verrucous Carcinoma of the Oral CavityStage IVC Squamous Cell Carcinoma of the Lip and Oral CavityStage IVC Squamous Cell Carcinoma of the OropharynxStage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVC Verrucous Carcinoma of the Oral CavityTongue CancerNCT00103259National Cancer Institute (NCI)71
进行中（未招募）
2 期
Bortezomib in Patients With Metastatic Castration-Resistant Prostate Cancer With PTEN DeletionMetastatic Castration-resistant Prostate CancerNCT06029998University of Utah22
已完成
2 期
Fase II Study With BRB for Non-Hodgkin Lymphoplasmacytic Lymphoma/Waldenstrom Macroglobulinemia'sWaldenstrom's MacroglobulinemiaNCT02371148Fondazione Italiana Linfomi - ETS38