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
- Conditions
- mieloma múltiple multiple myelomaMedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
- Registration Number
- EUCTR2008-003752-30-ES
- Lead Sponsor
- Merck & Co., Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 637
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method