EUCTR2008-003752-30-ES进行中（未招募）1 期
Estudio internacional, multicéntrico, aleatorizado, doble ciego de Vorinostat (MK-0683) o placebo en combinación con bortezomib en pacientes con mieloma multiple An International, Multicenter, Randomized, Double-Blind Study of Vorinostat (MK-0683) or Placebo in Combination with Bortezomib in Patients with Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 637
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
入选标准
- •1. Patient has an established diagnosis of multiple myeloma based on the myeloma diagnostic criteria.
- •2. 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.
- •3. 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.
- •4. Patient has measurable disease, defined as any quantifiable serum M-protein value and, where applicable, urine light chain of =200 mg/24 hours.
- •5. Patient has adequate organ function.
- •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
- •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 is receiving corticosteroid therapy (>10 mg of prednisone or equivalent). However, use of =10 mg of prednisone or equivalent is allowed for reasons other than myeloma.
研究者
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