5 results
Primary: to demonstrate that at least one dose regimen of BYM338 in sporadic inclusion body myositis patients will increase the distance traveled as measured by change from baseline at Week 52 of the 6 minute walking distance test relative to…
The present study is aimed at identifying the specific routes of plitidepsin excretion and elimination following its administration to patients with advanced tumors. Also, the study design may allow the identification and quantification, if possible…
Main Objective:To evaluate the long-term safety and tolerability of BYM338 in the treatment of sIBM and to further evaluate the effect of three BYM338dose regimens against placebo in increasing the distance traveled as measured by the 6 Minute…
The primary objective is to compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone as measured by progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma (MM). Secondary objectives…
Primary: Assess the effect of i.v. infusions of BYM338 on muscle volume of the thigh (assessed by MRI) at 4, 8, 16 and 24 weeks, compared to placebo, in COPD patients with pulmonary cachexia.Secondary: Effect on 6-minute walk test, safety and…