NCT00857324终止1 期
A Phase I/II, Multi-Center, Open Label Study of Vorinostat Plus Melphalan and Prednisone (ZMP) in Advanced, Refractory Multiple Myeloma Patients
Tiziana Marangon4 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- The maximum tolerated dose (MTD) of Vorinostat in association with MP
研究概览
简要总结
The purpose of this study is to determine whether the association of ZMP is safe and provides benefits in patients with relapsed/refractory MM.
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
- •Age ≥ 18 years
- •Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
- •Patient has given 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performance of any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- •Female patient is either post-menopausal for 24 consecutive months or surgically sterilized or agree to continuous abstinence from heterosexual sexual contact or willing to use effective contraception for 4 weeks prior to beginning study drug therapy, during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of therapy; female patients not pregnant or nursing; female with a negative pregnancy test.
- •Male patient agrees to use an acceptable method for contraception during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of Vorinostat therapy.
- •Patient was previously diagnosed with symptomatic MM based on standard criteria, and has measurable disease.
- •Patient is relapsed or refractory after a minimum of 3 weeks from prior therapies (patients must have recovered from toxicities related to prior therapies).
- •Patient has a Karnofsky performance status ≥ 60%.
- •Patient has a life-expectancy > 3 months.
排除标准
- •Any serious medical condition, laboratory abnormality, or psychiatric illness or social situation that would prevent the subject from signing the informed consent form or limit the compliance with study medications and requirements.
- •Pregnant or beast feeding females.
- •Use of any other concomitant standard/experimental anti-myeloma drug or therapy.
- •Known positive for HIV or active infectious hepatitis, type B or C.
- •Known congenital long QT syndrome.
- •Ongoing therapy with anti-arrhythmic drugs or other medicinal products which led to QT prolongation and cumulative high dose of anthracycline.
- •Any clinically significant illness that would, in the investigator's opinion, increase the patient's risk for toxicity. Patients has not plasmacell leukaemia defined as the presence of more than 20% plasma cells in the peripheral blood and an absolute plasma cell count of at least 2000/uL.
- •Patients has not a currently active malignancy, except non melanoma skin cancer and carcinoma in situ of the cervix. Patients should not be considered to have a currently active second malignancy if they have completed therapy for a prior malignancy and are disease free from prior malignancies for >5 years and are considered by their physicians to be at less then 30% risk of relapse
- •History of allergic reactions related to study drugs.
- •Prior exposure to HDACi. Patients exposed to valproic acid could be eligible with a wash out period of at least 30 days.
- •Patients scheduled to undergo autologous or allogenic bone marrow transplant within 4 week of the initiation of Vorinostat administration.
研究组 & 干预措施
ZMP
Experimental
Combination with Vorinostat, Melphalan and Prednisone
干预措施: Vorinostat (Drug)
结局指标
主要结局
The maximum tolerated dose (MTD) of Vorinostat in association with MP
时间窗: 1 year
A significant number of PR or higher (>40%) following the proposed ZMP therapy
时间窗: 1 year
The dose limiting toxicity (DLT)of Vorinostat with MP
时间窗: one year
次要结局
- Duration of Progression Free Survival(5 Years)
- Duration of Overall Survival(5 years)
研究者
Tiziana Marangon
Sponsor
University of Turin, Italy
研究点 (4)
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