NCT00148317已完成2 期
A Sequential Phase II Trial of the Combination of Bortezomib (VELCADE), Dexamethasone (DECADRON) and Pegylated Liposomal Doxorubicin (DOXIL) Followed by High Dose Cyclophosphamide in Multiple Myeloma Patients
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
- 38
- 试验地点
- 1
- 主要终点
- Efficacy of Drug Combination as Therapy for Myeloma (Overall Response Rate)
研究概览
简要总结
PRIMARY STUDY OBJECTIVES
- To evaluate the efficacy of the combination of bortezomib, dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as a therapy for two different subsets of multiple myeloma patients:
- Patients post first line therapy
- Patients with relapsed/refractory disease who are bortezomib-naïve
- To evaluate the safety of the combination of bortezomib and dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as therapy for patients with multiple myeloma.
SECONDARY STUDY OBJECTIVES
- To evaluate the role of the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide on the ability to collect > 10 x 106 CD34+ cells/kg in < 7 collections (for both subsets of multiple myeloma patients).
- To evaluate the survival of patients who receive the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide (for both subsets of patients).
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
- •Subject must voluntarily sign and understand written informed consent.
- •Confirmed diagnosis of multiple myeloma as specified by the SWOG criteria and is detailed in Appendix I.
- •Measurable disease as defined the following:
- •For patients post induction therapy, any measurable paraprotein in the serum or urine and/or any plasmacytoma present on physical exam or imaging.
- •For patients with relapsed/refractory disease, > 0.5 g/dL serum monoclonal protein, > 0.1 g/dL serum free light chains, > 0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s).
- •Age > or = than 18 years at the time of signing the informed consent form.
- •Karnofsky performance status> or =70% (>60% if due to bony involvement of myeloma).
- •Group A (post-induction therapy)- patients who have received only one prior treatment regimen (eg VAD, Thal/Dex, BLT-D, MP, BiRD, or DVd) with at least 20 patients having received a Revlimid based regimen or Group B(>1st line of therapy)- patients with relapsed/refractory multiple myeloma who have received two or more prior treatment regimens .
- •If the patient is a woman of childbearing age, she must have a negative serum or urine pregnancy test within 7 days of starting study and must use effective contraception throughout the course of the study.
- •Life expectancy > 12 weeks.
- •Absolute neutrophil count (ANC)> or = 1500 cells/mm3 (> or = 1000 for patients with bone marrow biopsy displaying > 50% involvement by myeloma)
- •Platelets count > or = 50,000/mm3 (> or = 30,000 for patients with bone marrow biopsy displaying > 50% involvement by myeloma)
- •Hemoglobin > 9.0 g/dL
- •Serum SGOT/AST <3.0 x upper limits of normal (ULN)
- •Serum SGPT/ALT <3.0 x upper limits of normal (ULN)
- •Serum creatinine < 2.5 mg/dL or creatinine clearance > 40ml/min
- •Serum total bilirubin < 1.5 x ULN
- •Patients must have a MUGA scan with LVEF >50%
排除标准
- •Patients with non-secretory MM (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine) unless measurable disease is available with imaging techniques such as MRI and PET scan.
- •Prior treatment with bortezomib.
- •Peripheral neuropathy of > Grade 2 as defined by CTCAE Version 3.0 (see Appendix II)
- •History of allergic reactions to compounds containing mannitol, bortezomib, conventional formulation of doxorubicin HCL or the components of DOXIL.
- •Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for ³ 5 years.
- •NYHA Class III or IV heart disease. History of active unstable angina, congestive heart disease, serious uncontrolled cardiac arrhythmia or myocardial infarction within 6 months.
- •Female patients who are pregnant or breastfeeding. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
- •Known HIV or hepatitis A, B, or C positivity
- •Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
- •Any concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to, uncontrolled hypertension, uncontrolled diabetes, active uncontrolled infection, and/or acute chronic liver disease (i.e., hepatitis, cirrhosis).
- •No prior anti-myeloma therapy within 2 weeks of treatment initiation.
研究组 & 干预措施
Treatment Arm
Experimental
干预措施: Bortezomib (Drug)
Treatment Arm
Experimental
干预措施: dexamethasone (Drug)
Treatment Arm
Experimental
干预措施: liposomal doxorubicin (Drug)
Treatment Arm
Experimental
干预措施: cyclophoshamide (Drug)
Treatment Arm
Experimental
干预措施: filgrastim (Drug)
结局指标
主要结局
Efficacy of Drug Combination as Therapy for Myeloma (Overall Response Rate)
时间窗: Best response at any point during each respective study phase was collected - once after consolidation/prior to mobilization (approximately 6 cycles after start of treatment), and once after mobilization
Myeloma response criteria developed by Bladé et al. was used to categorize response.
次要结局
- Progression Free Survival(Date of progression, assessed from start of trial to Final data cut off date (15 April 2011))
- Yield of CD34+ Stem Cells(Occurred after mobilization, and prior to Stem cell transplant; a 7 day limit was imposed on stem cell collection)
研究者
研究点 (1)
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