mieloma múltiple multiple myeloma MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Sponsors
Merck & Co., Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the duration of PFS in patients with multiple myeloma, after at least 1 prior treatment regimen, treated with bortezomib and vorinostat compared to patients treated with bortezomib and placebo.; Secondary Objective: •To assess the tolerability of vorinostat administered in combination with bortezomib •To determine the OS of patients with multiple myeloma, after at least 1 prior treatment regimen, treated with bortezomib and vorinostat compared to patients treated with bortezomib and placebo •To determine the TTP in patients with multiple myeloma, after at least 1 prior treatment regimen, treated with bortezomib and vorinostat compared to patients treated with bortezomib and placebo •To determine the objective RR of patients with multiple myeloma, after at least 1 prior treatment regimen, treated with bortezomib and vorinostat compared to patients treated with bortezomib and placebo using the European Blood and Marrow Transplant Group (EBMT) Criteria •To measure pharmacokinetic parameters and conduct pharmacokinetic/ pharmacodynamic modeling to explore exposure/response relationships in patients treated with bortezomib together with vorinostat compared to bortezomib together with placebo ;Primary end point(s): The primary efficacy endpoint for this study is PFS, the time from randomization to disease progression or death due to any cause. | — |
Countries
Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hungary, Italy, Portugal, Spain, United Kingdom
Outcome results
None listed