ACVDL Treatment for Patients With Newly Diagnosed Multiple Myeloma (ACVDL)
2019年2月27日 更新者:Vejle Hospital
An Open-Label Phase II Study of the Safety and Efficacy of Doxorubicin and Cyclophosphamide in Combination With Bortezomib, Lenalidomide, and Dexamethasone for Treatment of Patients With Newly Diagnosed Multiple Myeloma
The purpose of this study is to evaluate the efficacy and safety of the combination treatment of doxorubicin, cyclophosphamide, bortezomib, dexamethasone, and lenalidomide in newly diagnosed multiple myeloma patients.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
35
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Vejle、丹麦
- Department of Hematology
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male or female subjects ≥ 18 years at the time of signing informed consent.
Subject is diagnosed with symptomatic multiple myeloma based on the International Myeloma Working Group Diagnostic Criteria (Kyle 2009):
- Monoclonal plasma cells in the bone marrow ≥ 10% and/or presence of a biopsy-proven plasmacytoma.
- Monoclonal protein present in the serum and/or urine. If no monoclonal protein is detected (non-secretory disease), then ≥ 30% monoclonal bone marrow plasma cells and/or a biopsy-proven plasmacytoma is required.
- Myeloma-related organ dysfunction
The myeloma disease burden must be measurable with at least one of the following criteria (Durie et al. 2006):
- Serum M-protein ≥ 10 g/l
- Urine M-protein ≥ 200 mg/24 h
- Involved FLC ≥ 100 mg/l provided serum FLC ratio is abnormal
- Bone marrow plasma cells > 30%
- Subject has a Karnofsky performance status of ≥ 60.
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Subject is willing and able to comply with the protocol as judged by the investigator.
Exclusion Criteria:
- Any prior systemic therapy for multiple myeloma.
- Other therapies such as biologic therapy and chemotherapy less than 3 months prior to screening.
- Any prior treatment with doxorubicin or other anthracycline.
- Concurrent or recent (less than 2 weeks prior to Screening) radiotherapy or surgery.
- Prior glucocorticoid treatment of multiple myeloma exceeding dexamethasone 20mg/day for a maximum of 7 days. Topical glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted.
- More than or equal to grade 2 peripheral neuropathy according to the NCI-CTC criteria on clinical examination within 14 days before enrolment (Day 1 of Cycle 1).
- Evidence of mucosal or internal bleeding and/or platelet counts < 50 x 10^9/l. Platelet transfusions may not be used to meet PLT eligibility criteria.
- Absolute neutrophil count (ANC) < 1 x 10^9/l. Growth factors may not be used to meet ANC eligibility criteria.
- Hemoglobin < 5.0 mmol/l. The subject may be included after correction of the hemoglobin level by transfusion or treatment with erythropoietin.
- Alanine aminotransferase (ALAT) > 2 x ULN.
- Myocardial infarction within 6 months prior to enrolment or New York Heart Association (NYHA) Class IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant.
- Clinically relevant active infection or serious co-morbid medical conditions, such as chronic obstructive or chronic restrictive pulmonary disease, and cirrhosis.
- Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the subject at unacceptable risk if he/she were to participate in the study.
- Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in situ prostate cancer for which the subject has been disease-free for at least 3 years.
- Female subject is pregnant or breast-feeding. The first serum pregnancy test to be done within 10-14 days prior to the study treatment start and repeated serum pregnancy test to be done within 24 hours prior to the start of study treatment.
- Female subjects who are of childbearing potential (biologically capable of becoming pregnant) or men with partners of childbearing potential, who are unwilling or unable to use effective means of contraception. The means of contraception must be TWO acceptable methods of birth control, one highly effective method (hormonal contraceptives pills, injections or implants, tubal ligation, partner's vasectomy) and one additional effective method (condom, diaphragm, cervical cap) AT THE SAME TIME, at least 28 days before she or he starts ACVDL and for at least 28 days after the last dose of ACVDL.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Uncontrolled diabetes mellitus at the discretion of the investigator.
- Hypersensitivity and/or contraindication to any one of the Investigational Medicinal Products (IMP), acyclovir or similar anti-viral drug.
- POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes).
- Known HIV infection.
- Known active hepatitis B or C viral infection.
- Known intolerance to steroid therapy.
- Current or recent (within 30 days prior to Screening) treatment with another investigational drug.
- Unable to comply with the administration of the study treatment.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:ACVDL
ACVDL is a combination of doxorubicin, cyclophosphamide, bortezomib, dexamethasone, and lenalidomide
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50 mg/m2 IV on day 1 of a 21-day cycle
1.3 mg/m2 IV push on days 2 and 9 of a 21-day cycle
15 mg orally on days 1-14 of a 21-day cycle
20 mg orally on days 2, 3, 9, and 10 of a 21-day cycle
750 mg/m2 IV on day 1 of a 21-day cycle
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Response rate
大体时间:4 weeks after completion of 8 treatment cycles
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4 weeks after completion of 8 treatment cycles
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次要结果测量
结果测量 |
大体时间 |
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无进展生存期
大体时间:4年
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4年
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进展时间
大体时间:4年
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4年
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Complete response rate
大体时间:4 weeks after completion of 8 treatment cycles
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4 weeks after completion of 8 treatment cycles
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Very good partial response rate
大体时间:4 weeks after completion of 8 treatment cycles
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4 weeks after completion of 8 treatment cycles
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2011年11月1日
初级完成 (实际的)
2014年5月1日
研究完成 (实际的)
2018年8月28日
研究注册日期
首次提交
2011年11月21日
首先提交符合 QC 标准的
2011年11月24日
首次发布 (估计)
2011年11月29日
研究记录更新
最后更新发布 (实际的)
2019年3月1日
上次提交的符合 QC 标准的更新
2019年2月27日
最后验证
2019年2月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- SDU/VS-HKU/CTC-2011-01
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Doxorubicin的临床试验
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National Cheng-Kung University HospitalNational Cheng Kung University; The Industrial Technology Research Institute完全的