595492 Disclosed herein are processes for preparing 3-(4-amino-1-oxo-1,3- dihydro-isoindol-2-yl)-piperidine-2,6-dione (I) (lenalidomide) and its intermediate 3-(1-oxo- 4-nitro-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione, and the use of lenalidomide for reducing levels of TNF? and/or for elevating levels of adenosine 3,5-cyclic monophosphate, and in the treatment of an autoimmune disease, an immune disease, cancer, an oncogenic, oncological or cancerous condition, undesired angiogenesis, multiple myeloma, myelodysplastic syndromes, inflammation, an inflammatory disorder or a viral infection.