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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Percent of Particpants Achieving Overall Combined Complete Response (CR) Following Induction
研究概览
简要总结
The purpose of this Phase 2 randomized study is to evaluate the efficacy and safety of treatment with a regimen of VELCADE, dexamethasone, and thalidomide (VDT) or VELCADE, dexamethasone, thalidomide, and cyclophosphamide (VDTC) in subjects with newly diagnosed symptomatic multiple myeloma who have received no prior treatment and are candidates to receive high-dose therapy and autologous bone marrow/stem cell transplantation.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between ≥18 and ≤70 years
- •Patient is a candidate for HDT combined with an autologous SCT
- •Karnofsky Performance Status score of ≥60%
- •Multiple myeloma diagnosed according to the following standard criteria AND requiring systemic therapy:
- •Presence of M-component in serum and/or urine, plus clonal plasma cells in the bone marrow and/or a documented clonal plasmacytoma
- •PLUS 1 or more of the following:
- •Calcium elevation (>11.5 mg/dL or >2.65 mmol/L)
- •Renal insufficiency (creatinine >2 mg/dL or >177 umol/L)
- •Anemia (hemoglobin <10 g/dL [<12.5 mmol/L] or at least 2 mg/dL [1.25 mmol/L] below normal)
- •Bone disease (lytic lesions or osteopenia)
- •AND fulfill criteria for measurable disease, as defined by at least 1 of the following 3 measurements:
- •Serum M-protein ≥1 g/dL (≥10 g/L)
- •Urine M-protein ≥200 mg/24 h
- •Serum free light chain (FLC) assay: Involved FLC level ≥10 mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal
- •Women of childbearing potential must agree to use 2 methods of contraception.
- •Males must agree to use barrier contraception.
- •Subjects (or their legally acceptable representatives) must have signed an informed consent document.
- •To participate in the optional pharmacogenomic component of this study, subjects (or their legally acceptable representative) must have signed the informed consent form. Refusal to consent for this component does not exclude a subject from participation in the clinical study.
排除标准
- •Diagnosis of smoldering OR non-secretory multiple myeloma or monoclonal gammopathy of undetermined significance (MGUS).
- •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.
- •Radiation therapy and/or plasmapheresis within 15 days before randomization.
- •History of allergic reaction attributable to compounds being given (VELCADE, thalidomide, dexamethasone, and/or cyclophosphamide) or compounds containing boron or mannitol.
- •Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.
- •Uncontrolled or severe cardiovascular disease
- •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
- •Pregnant or lactating women: A serum β-hCG pregnancy test must be performed at the Screening visit for female subjects of childbearing potential.
- •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, as well as family members of the employees or the investigator.
研究组 & 干预措施
1
bortezomib, dexamethasone, and thalidomide
干预措施: bortezomib, dexamethasone, and thalidomide (Drug)
2
bortezomib, dexamethasone, thalidomide, and cyclophosphamide
干预措施: bortezomib, dexamethasone, thalidomide, and cyclophosphamide (Drug)
结局指标
主要结局
Percent of Particpants Achieving Overall Combined Complete Response (CR) Following Induction
时间窗: all data included in clinical database as of 10 April 2009
Percent of Particpants Achieving Overall combined complete response (CR w/normalized serum κ:λ ratio + CR + near complete response (nCR)) following induction therapy. * CR criteria: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow. * κ:λ ratio: normal free light chain (FLC) ratio * nCR criteria: positive immunofixation analysis of serum or urine as the only evidence of disease; disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow.
次要结局
- Percent of Participants Achieving Overall Combined Complete Response (CR) Following High-dose Chemotherapy (HDT)/Stem Cell Transplantation (SCT)(all data included in clinical database as of 10 April 2009)