Conditions: Multiple Myeloma
Keywords: Myeloma DACi Bortezomib Combination Panobinostat LBH589D relapsed Velcade® Combination,
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 767
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Panobinostat intervention 2: Bortezomib intervention 3: Dexamethasone intervention 4: Placebo
Intervention descriptions: intervention 1: Panobinostat was administered 3x week ( 2 weeks on 1 week off) intervention 2: Bortezomib was administered 2 x week ( 2weeks on 1 week off) intervention 3: Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration intervention 4: Placebo was administered 3x week ( 2 weeks on 1 week off)

Protocol document: