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 myeloma diagnostic criteria. 2. Patient has relapsed or refractory multiple myeloma after at least 2 prior treatment regimens as per the EBMT response criteria and meets both of the following conditions: • Patient's myeloma was refractory to bortezomib; defined as no response on prior bortezomib-containing regimens or progression on or within 60 days of a bortezomib-containing regimen. • Patient was exposed to an IMiD (thalidomide or lenalidomide); defined as patients who received at least 1 dose of an IMiD and were intolerant to or whose myeloma relapsed or was refractory to IMiD containing regimen. 3. Patient has received at least 2 prior (standard or experimental) anti-myeloma regimens. 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 is eligible). 2. Patient plans to undergo any type of bone marrow transplantation (allogeneic, or autologous) within 4 weeks after initiating study therapy. 3. Patient had prior treatment with vorinostat or other 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To define the objective response rate associated with the administration of vorinostat in combination with bortezomib to patients with relapsed or refractory multiple myeloma after at least 2 prior treatment regimens.; Secondary Objective: To assess the tolerability and adverse experience profile of vorinostat administered in combination with bortezomib. To assess the time to disease progression associated with the administration of vorinostat in combination with bortezomib. To evaluate the progression-free survival associated with the administration of vorinostat in combination with bortezomib. To evaluate overall survival associated with the administration of vorinostat in combination with bortezomib. ;Primary end point(s): The primary endpoint for this study is response rate, defined as the percentage of subjects who achieve partial response or better during the study. | — |
Countries
Belgium, Germany, Greece, Italy, Spain, United Kingdom
Outcome results
None listed