Clinical experiment designed to assess clinical efficacy targeting N/A in Human patients. Primary outcome: Progression-free survival
A multicentre, randomised, placebo-controlled, double-blind phase 3 clinical trial comparing the efficacy and safety of panobinostat in combination with bortezomib and dexamethasone versus placebo with bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma. The study enrolled 768 patients who had received between one and three previous treatment regimens. Patients were randomly assigned 1:1 to receive either panobinostat (20 mg orally on days 1, 3, 5, 8, 10, 12) or placebo, both combined with bortezomib (1.3 mg/m² IV on days 1, 4, 8, 11) and dexamethasone (20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12) in 21-day cycles. The trial was stratified by number of previous treatment lines and previous bortezomib use. The primary endpoint was progression-free survival assessed according to modified European Group for Blood and Marrow Transplantation criteria.
Randomized, double-blind, placebo-controlled phase 3 trial with 21-day treatment cycles. Panobinostat 20mg orally on days 1,3,5,8,10,12 or placebo, combined with bortezomib 1.3mg/m² IV on days 1,4,8,11 and dexamethasone 20mg orally on days 1,2,4,5,8,9,11,12. Randomization 1:1 via interactive web-based system, stratified by prior treatment lines and bortezomib use.
Improved progression-free survival with panobinostat combination based on preclinical synergistic anti-myeloma activity
Statistically significant improvement in progression-free survival in the panobinostat group compared to placebo group
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