EUCTR2008-003752-30-IT进行中（未招募）不适用
An International, Multicenter, Randomized, Double-Blind, Study of Vorinostat (MK-0683) or Placebo in Combination with Bortezomib in Patients Multiple MyelomaMK-0683-088 - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •A patient must satisfy each of the following criteria in order to qualify for participation in
- •1. Patient, or the patient?s legal representative, has voluntarily agreed to participate by
- •giving written informed consent. For those institutions that do not allow a legal
- •representative to provide consent on behalf of a patient, patients must be able to
- •provide written informed consent for themselves.
- •2. Patient is ≥18 years of age on the day of signing informed consent.
- •3. Patient has an established diagnosis of multiple myeloma based on the myeloma
- •diagnostic criteria located in Appendix 6.2. [9; 10]
- •4. Patient has received at least 1 but not more than 3 prior anti-myeloma regimens and
- •has progressive disease after the most recent treatment regimen as per the European
- •Blood and Marrow Transplantation Group (EBMT) Criteria located in Appendix 6.6
- •5. Patient who received prior bortezomib-containing regimen and meets the following
- •criteria is also eligible:
- •While on prior bortezomib-based therapy, the patient must have achieved a
- •minimal response (MR), partial response (PR), or complete response (CR).
- •Patient was not considered bortezomib refractory. Bortezomib refractory is
- •defined as no response on prior bortezomib-containing regimens or
- •progression on or within 60 days of a bortezomib-containing regimen.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A patient meeting any of the following criteria is not eligible to participate in the study:
- •1. Patient has had any prior allogeneic bone marrow transplant (patient with prior
- •autologous transplant are eligible).
- •2. Patient plans to undergo any type of bone marrow transplantation (allogeneic, or
- •autologous) within 4 weeks after initiating study therapy.
- •3. Patient has had prior treatment with vorinostat or HDAC inhibitors (e.g.,
- •depsipeptide, MS-275, LAQ-824, PXD-101, LBH589, MGCD0103, CRA024781,
- •etc.). Patients who have received compounds with HDAC inhibitor-like activity, such
- •as valproic acid, as anti-tumor therapy should not be enrolled in this study. (Patients
- •who have received such compounds for other indications, e.g. valproic acid for
- •epilepsy, may enroll after a 30-day washout period.)
- •4. Patient was unable to tolerate prior treatment with bortezomib.
- •5. Patient has uncontrolled intercurrent illness or circumstances that could limit
- •compliance with the study, including, but not limited to the following: acute or
- •chronic graft versus host disease, uncontrolled hypertension, symptomatic congestive
- •heart failure, unstable angina pectoris, myocardial infarction within past 6 months,
- •uncontrolled cardiac arrhythmia, renal failure, psychiatric or social conditions that
- •may interfere with patient compliance, or any other condition (including laboratory
- •abnormalities) that in the opinion of the Investigator places the patient at
- •unacceptable risk for adverse outcome if he/she were to participate in the study.
研究者
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