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NCT01023308: Phase 3 - Panobinostat or Placebo With Bortezomib & Dex in Relapsed Myeloma PANORAMA-1

Updated: Mar 28, 2022

PANORAMA



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.


Sponsor:

Novartis Pharmaceuticals


International Study

Multiple Locations

ClinicalTrials.gov Identifier: NCT01023308


 


 

Drug: Panobinostat

Drug: Bortezomib

Drug: Dexamethasone

Drug: Placebo

 

Lancet Oncol; Oct. 2014


Adv Ther. 2016 Nov


Lancet Haematol. 2016 Nov


Blood. 2016 Feb


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