Velcade Receives Additional Approvals In Europe – The approved uses of Velcade ^[1] (bor­tez­o­mib) for mul­ti­ple myeloma patients were recently ex­panded in the Euro­pean Union. These addi­tional approved uses in­clude treat­ment of newly diag­nosed trans­plant-eligible myeloma patients with Velcade plus dexa­meth­a­sone ^[2] (Decadron) or Velcade plus thalidomide ^[3] (Thalomid) and dexa­meth­a­sone, as well as retreatment of re­lapsed myeloma patients with Velcade for those who responded to prior Velcade ther­apy.  Previously, Velcade was approved in com­bi­na­tion with melphalan ^[4] (Alkeran) and prednisone ^[5] for the treat­ment of newly diag­nosed myeloma patients who are in­eli­gible for stem cell trans­plan­ta­tion, or as a single agent for the treat­ment of re­lapsed myeloma patients with one prior ther­apy who have had a trans­plant or are in­eli­gible for a trans­plant.   For more in­for­ma­tion, please see the August 8 ^[6] and June 28 ^[7] Johnson & Johnson press releases about the new ap­­prov­als for newly diag­nosed and re­lapsed myeloma patients.

Pilot Clinical Trial To Test Whether Anti-Depressant Desipramine Assists With Stem Cell Mobilization – Researchers from the Albert Einstein College of Medicine in New York City have launched a clin­i­cal trial that will de­ter­mine how well the antidepressant desipramine ^[8] (Norpramin, Pertofrane) in com­bi­na­tion with Neupogen ^[9] (filgrastim), which is a type of granulocyte colony-stimulating factor (G-CSF), works to mobilize stem cells in mul­ti­ple myeloma patients undergoing stem cell trans­plan­ta­tion. A pre­vi­ous study ^[10] in mice showed that desipramine plus G-CSF mobilized more stem cells than G-CSF alone.  For more in­for­ma­tion about the study or how to en­roll, see the clinical trial ^[11] description.

Clinical Trial To Study Modified Version Of Melphalan Plus Dexa­meth­a­sone For Re­lapsed / Re­frac­tory Myeloma – A new Phase 1/2 clin­i­cal trial is testing the ef­fi­cacy and safety of a modified version of mel­pha­lan in com­bi­na­tion with dexa­meth­a­sone for re­lapsed and re­frac­tory myeloma patients. The modified version of mel­phalan, known as mel­phalan-flufenamide or melflufen ^[12], is being devel­oped by the Swedish pharma­ceu­ti­cal com­pany Oncopeptides and consists of melphalan bound to flufenamide.  The drug only be­comes active once it enters a cell and mel­phalan is released from flufenamide.  Cancer cells more efficiently ac­ti­vate the drug, in­creas­ing the con­cen­tra­tion of mel­phalan in cancer cells com­pared to healthy cells. The study is sponsored by Oncopeptides and is being conducted in the United States and Europe. For more in­for­ma­tion about the study or how to en­roll, see the clinical trial ^[13] description and related Oncopeptides press release ^[14].