Conditions: Multiple Myeloma
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 34
Healthy volunteers: no

Brief summary:
The purposes of this study are:

* To determine the maximum tolerated dose (MTD) for the combination of oral vorinostat and bortezomib in participants with advanced multiple myeloma
* To assess the safety and tolerability of this regimen and to document the participant's clinical status (by anti-tumor activity) for this combination, as determined per standard of care.

Detailed description:

Arms:
arm 1: Vorinostat capsules given twice daily (b.i.d.); bortezomib injection given on Days 4, 8, 11, and 15 of each cycle. arm 2: Vorinostat capsules given b.i.d.; bortezomib injection given on Days 4, 8, 11, and 15 of each cycle. arm 3: Vorinostat given once daily (q.d.); bortezomib given on Days 1, 4, 8, and 11 of each cycle. arm 4: Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle. arm 5: Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle. arm 6: Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.

Interventions: intervention 1: vorinostat intervention 2: bortezomib
Intervention descriptions: intervention 1: Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break). intervention 2: Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.

Protocol document: