NCT00111319已完成3 期
An Open-Label, Randomized Study of VELCADE/Melphalan/Prednisone Versus Melphalan/Prednisone in Subjects With Previously Untreated Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Time to progression
研究概览
简要总结
The primary reason for this study is to determine whether the addition of VELCADE (bortezomib) for injection to standard melphalan/prednisone (MP) therapy improves the time to disease progression (TTP) in subjects with previously untreated multiple myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Subjects must satisfy the following criteria to be enrolled in the study:
- •Male or female
- •Not a candidate for HDT/SCT due to: age - subject is 65 years or older or in subjects less than 65 years of age - presence of important comorbid condition(s) likely to have a negative impact on tolerability of HDT/SCT.
- •Symptomatic multiple myeloma or asymptomatic multiple myeloma with related organ or tissue damage. Asymptomatic multiple myeloma-related organ or tissue damage can include presence of asymptomatic lytic bone lesion or plasmacytoma, or presence of anemia, renal function impairment, or hypercalcemia, as long as the criteria for pre-treatment clinical laboratory values indicated below are met.
- •Presence of measurable disease, defined as:
- •For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value.
- •For oligosecretory or nonsecretory multiple myeloma, measurable disease is defined by the presence of measurable soft tissue or organ (not bone) plasmacytomas as determined by clinical examination or applicable radiographs.
- •Karnofsky performance status score of equal or greater then 60%.
- •Willing and able to complete the PRO instruments
- •Agrees to use an acceptable barrier method for contraception for the duration of the study (for male subjects); If female subjects are still having menstrual periods and are not surgically sterile, they must be practicing an effective method of birth control before entry, and throughout the study, and have a negative serum B-HCG pregnancy test at screening.
- •Have pretreatment clinical laboratory values meeting the criteria as described in the protocol within 14 days before randomization.
- •Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •Diagnosis of smoldering multiple myeloma or monoclonal gammopathy of undetermined significance (MGUS, hypercalcemia, and renal insufficiency related to the monoclonal protein; and (if determined) proportion of plasma cells in the bone marrow of 10% or less.
- •Diagnosis of Waldenström's disease or other conditions in which IgM M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
- •Prior or current systemic therapy for multiple myeloma including steroids (with the exception of emergency use of a short course [maximum of 4 days] of steroids before randomization or of prior or current use of bisphosphonates)
- •Radiation therapy within 30 days before randomization
- •Plasmapheresis within 30 days before randomization
- •Major surgery within 30 days before randomization (kyphoplasty is not considered major surgery)
- •History of allergic reaction attributable to compounds containing boron or mannitol
- •Peripheral neuropathy or neuropathic pain Grade 2 or higher.
- •Uncontrolled or severe cardiovascular disease, including myocardial infarction, within 6 months of enrollment, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
- •Other malignancy within the past 5 years. Exceptions if treated and not active include the following: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix
- •Concurrent medical condition or disease (e.g., active systemic infection, uncontrolled diabetes) that is likely to interfere with study procedures or results, or that, in the opinion of the investigator would constitute a hazard for participating in this study
- •Use of any investigational drugs within 30 days before randomization
- •Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, or family members of the employees or the investigator.
结局指标
主要结局
Time to progression
次要结局
- Progression-free survival, overall response rate, overall survival, time to first response, duration of response, CR rate, and patient reported outcomes as assessed using the EORTC QLQ-C30, FACIT-F and EQ-5D instruments.
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
A Study of PS-341 Given to Patients With Multiple Myeloma Who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039Multiple MyelomaNCT00063726Millennium Pharmaceuticals, Inc.600
已完成
2 期
A Study to Evaluate Two Different Regimens of VELCADE in Combination With Dexamethasone, Thalidomide and Cyclophosphamide (VDT vs VDTC) in Newly Diagnosed Multiple MyelomaMultiple MyelomaNCT00531453Millennium Pharmaceuticals, Inc.98
已完成
不适用
An Observational Study of Chinese Multiple Myeloma Patients Treated With VelcadeMultiple MyelomaNCT01675245Xian-Janssen Pharmaceutical Ltd.532
已完成
3 期
A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple MyelomaMultiple MyelomaNCT02195479Janssen Research & Development, LLC706
进行中（未招募）
1 期
A Phase 2, Randomized Study of VELCADE (bortezomib), Dexamethasone and Thalidomide versus VELCADE (bortezomib), Dexamethasone, Thalidomide and Cyclophosphamide in Subjects with Previously Untreated Multiple Myeloma who are Candidates for Autologous Transplantation - NDMedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myelomaMULTIPLE MYELOMAEUCTR2006-006050-10-ITJANSSEN-CILAG INTERNATIONAL NV98