Calendario›AMGN›AMG 531

AMG 531

A Safety and Efficacy Study to Evaluate AMG 531 Treatment in Subject With Myelodysplastic Syndrome Receiving Revlimid

Ensayo de AMGEN INC en Myelodysplastic Syndromes · Thrombocytopenia (del registro, en inglés).

Más ensayos de: Síndromes mielodisplásicos.

Fase

Fase 2

Estado

Completado

Participantes

39

previstos

Fin del objetivo primario

mar 2009

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en dic 2006.

Qué mide

Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period through interim follow-up visit (up to 16 weeks)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a dose and schedule finding study of AMG 531 designed to assess the activity of AMG 531 to reduce the rate of clinically significant bleeding and blood transfusions in subjects with myelodysplastic syndrome (MDS) receiving lenalidomide. Subjects with MDS that are planned to receive at least four cycles of lenalidomide for treatment of their disease are appropriate to screen for this study. All subjects meeting the eligibility criteria will receive lenalidomide 10 mg capsule by mouth daily every day of each 28-day cycle. Subjects will receive AMG 531 or placebo once a week by subcutaneous injection for 16 weeks.

Más ensayos de AMGN

Todos los de AMGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00418665), actualizada en ene 2011.