Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma
Status:
Completed
Trial end date:
2015-07-30
Target enrollment:
Participant gender:
Summary
Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of
HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded
protein aggregates and triggers myeloma cell death. Combination of pan-DAC and protease
inhibition by co-treatment with panobinostat (PAN) and bortezomib (BTZ) has demonstrated
synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. Furthermore,
clinical experience in advanced multiple myeloma (MM) patients treated by oral panobinostat
and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and
manageable toxicity profile.
Given the medical need for improved treatment strategies for patients with previously treated
and relapsed MM, the purpose of this prospective, multinational, randomized, double-blind,
placebo-controlled, parallel group Phase III study is to compare the results in
progression-free survival of 2 combination therapies, panobinostat with bortezomib and
dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously
treated MM whose disease has recurred or progressed.