Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria: Adults with refractory or relapsed multiple myeloma Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (a measurement to determine participant's ability to perform daily activities) Adequate bone marrow reserve Adequate hepatic and renal function Ability to swallow capsules 3 weeks or more since prior chemotherapy and have recovered from prior toxicities Exclusion Criteria: Participants who plan to have a bone marrow transplant within 4 weeks of start of treatment Participants with prior treatment with other investigational agents with a similar anti-tumor mechanism Participants with other active/uncontrolled clinically significant illness Pregnant or nursing female participants Participants who received bortezomib within 3 months of start of this trial
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
vorinostat 200 mg + bortezomib 0.7 mg/m^2
vorinostat 200 mg + bortezomib 0.9 mg/m^2
vorinostat 300 mg + bortezomib 1.3 mg/m^2
vorinostat 400 mg + bortezomib 0.9 mg/m^2
vorinostat 400 mg + bortezomib 1.1 mg/m^2
vorinostat 400 mg + bortezomib 1.3 mg/m^2
Vorinostat capsules given twice daily (b.i.d.); bortezomib injection given on Days 4, 8, 11, and 15 of each cycle.
Vorinostat capsules given b.i.d.; bortezomib injection given on Days 4, 8, 11, and 15 of each cycle.
Vorinostat given once daily (q.d.); bortezomib given on Days 1, 4, 8, and 11 of each cycle.
Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.
Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.
Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.