At a glance
ClinicalIndex Comparison Record- ✓Age ≥20 years
- ✓Established diagnosis of multiple myeloma based on diagnostic criteria
- ✓1 to 3 prior anti-myeloma regimens with progressive disease after most recent treatment
- ✓Adequate organ function
- ✕Prior allogeneic bone marrow transplant or planned bone marrow transplantation during study
- ✕Known hypersensitivity to vorinostat or bortezomib components
- ✕Active hepatitis B or C, HIV positive, or plasma cell leukemia
- ✕Prior treatment with vorinostat or HDAC inhibitors
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Open-Label, Phase I Study of MK-0683 in Combination With Bortezomib in Patients With Relapsed and/or Refractory Multiple Myeloma
In Brief
A Phase 1 clinical trial evaluating Vorinostat and Bortezomib for Multiple Myeloma. Completed, enrolled 9 participants.
Detailed Summary
The primary purpose of this clinical study is to determine the recommended clinical doses of vorinostat (MK-0683) and bortezomib administered in combination to participants with relapsed and/or refractory multiple myeloma (MM). It was hypothesized that administration of vorinostat in combination with bortezomib is sufficiently safe and tolerated well enough to permit further study in participants with relapsed and/or refractory MM. Study results are based on data collected up to the data cut-off date of 20-March-2011.
Study Details
Timeline
Interventions
Vorinostat (MK-0683) three or four 100 mg capsules taken by mouth with food.
Bortezomib (1.0 or 1.3 mg/m\^2) intravenous infusion.