Lendexal in Patients With Primary Systemic Amyloidosis (AL) Newly Diagnosed

Summary

Primary outcome measure: \- Hematologic response rate to the association of Lenalidomide, Cyclophosphamide and Dexamethasone. Secondary outcome measures: * Organ response rate. * Predictors of response (cardiac biomarkers, serum free light chains). * Toxicity * Safety (type, frequency, severity and relationship of adverse events to the study drug). * Duration of response. * Time to progression. * Overall survival

Timeline

Start

2010-10

Primary completion

2012-09

Completion

2016-12

Publications

• Cibeira MT, Oriol A, Lahuerta JJ, Mateos MV, de la Rubia J, Hernandez MT, Granell M, Fernandez de Larrea C, San Miguel JF, Blade J; PETHEMA cooperative study group. A phase II trial of lenalidomide, dexamethasone and cyclophosphamide for newly diagnosed patients with systemic immunoglobulin light chain amyloidosis. Br J Haematol. 2015 Sep;170(6):804-13. doi: 10.1111/bjh.13500. Epub 2015 May 14.

Drugs

Indications