Dicho ensayo de Fase III empezo a principios del 2003 .....Jesus San Miguel es una autoridad Mundial en este tipo de Cancer y es uno de los avaladores de la Lenalidomide .
Nuestra Aplidin lo tendra dificil ante los cientos de ensayos clinicos que hay en marcha para Myeloma Multiple .... pero como vemos Sousa lo avala a ultranza ...de por medio tambien esta Jesus San Miguel en los ensayos .....y parece ser que se esta planeando una Fase III en combinacion con todo un Crack .... con Velcade ( Bortezomib ) Farmaco del viejo conocido J&J en EEUU y de Millenium en EU ....Horror o garantia .... veremos tras la experiencia del Yondelis con J&J .
Resultados de la Fase III del Lenalidomide :
Methods Of 351 patients who had received at least one previous antimyeloma therapy, 176 were randomly assigned to receive 25 mg of oral lenalidomide and 175 to receive placebo on days 1 to 21 of a 28-day cycle. In addition, all patients received 40 mg of oral dexamethasone on days 1 to 4, 9 to 12, and 17 to 20 for the first four cycles and subsequently, after the fourth cycle, only on days 1 to 4. Patients continued in the study until the occurrence of disease progression or unacceptable toxic effects. The primary end point was time to progression.
Results The time to progression was significantly longer in the patients who received lenalidomide plus dexamethasone (lenalidomide group) than in those who received placebo plus dexamethasone (placebo group) (median, 11.3 months vs. 4.7 months; P<0.001). A complete or partial response occurred in 106 patients in the lenalidomide group (60.2%) and in 42 patients in the placebo group (24.0%, P<0.001), with a complete response in 15.9% and 3.4% of patients, respectively (P<0.001). Overall survival was significantly improved in the lenalidomide group (hazard ratio for death, 0.66; P=0.03). Grade 3 or 4 adverse events that occurred in more than 10% of patients in the lenalidomide group were neutropenia (29.5%, vs. 2.3% in the placebo group), thrombocytopenia (11.4% vs. 5.7%), and venous thromboembolism (11.4% vs. 4.6%).
Aqui teneis una video conferencia del Doctor Jesus San Miguel sobre nuetra Aplidin en Myeloma ( 2005 ) :
http://myeloma.org/main.jsp?type=article&id=1684