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Velcade Receives Additional Approvals In Europe – The approved uses of Velcade (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 (Decadron) or Velcade plus thalidomide (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 (Alkeran) and prednisone 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 and June 28 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 (Norpramin, Pertofrane) in com­bi­na­tion with Neupogen (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 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 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, 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 description and related Oncopeptides press release.

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Stem Cell Mobilization With Cyclophosphamide And G-CSF Is More Effective And Less Expensive Than Mozobil And G-CSF – Findings from a recent study show that cyclo­phos­phamide (Cytoxan) plus granulocyte colony-stimulating factor (G-CSF) is more ef­fec­tive than Mozobil (plerixafor) plus G-CSF as a stem cell mobilization ther­apy for mul­ti­ple myeloma patients. Both Mozobil and cyclo­phos­phamide in­crease the number of stem cells that can be harvested during collection. Patients in the recent study who re­ceived the cyclo­phos­pha­mide-G-CSF com­bi­na­tion collected sig­nif­i­cantly more stem cells than patients who re­ceived Mozobil plus G-CSF (16.6 × 10⁶ cells/kg versus 11.6 × 10⁶ cells/kg). In addi­tion, the in­ves­ti­ga­tors found that the total cost of stem cell mobilization was less with cyclo­phos­pha­mide plus G-CSF than with Mozobil plus G-CSF. However, cyclo­phos­phamide plus G-CSF was asso­ci­ated with sig­nif­i­cantly higher rates of side effects, antibiotic use, and hospi­tal­iza­tion. For more in­for­ma­tion, please see the study in Bone Marrow Transplantation (abstract).

Psychosocial Support May Be Appropriate For Newly Diagnosed Myeloma Patients - Results from a German study in­di­cate that about half of newly diag­nosed mul­ti­ple myeloma patients desire psychosocial sup­port soon after their diag­nosis. Psychosocial sup­port in­cludes services in­tended to help a myeloma patient with the psychological, emotional, social, and practical effects of their diag­nosis and treat­ment.  Of the 114 myeloma patients in­cluded in the study, 51 per­cent desired psychosocial sup­port, with depressed and younger patients having the greatest interest. Specifically, patients were most interested in relaxation techniques (21 per­cent), psychological counseling (20 per­cent), and peer sup­port groups (18 per­cent). At the time of diag­nosis, 24 per­cent of patients reported signs of depression and 8 per­cent reported signs of anxiety. Based on their findings, the re­searchers rec­om­mend that a variety of dif­fer­en­t types of psychosocial sup­port be offered to myeloma patients at the time of diag­nosis. For more in­for­ma­tion, please refer to the study in the journal Psycho-Oncology (abstract).

Preclinical Study Indicates Melphalan-Flufenamide May Be Effective In Multiple Myeloma – Results from a pre­clin­i­cal study in­di­cate that a new mel­phalan-based treat­ment may be ef­fec­tive for mul­ti­ple myeloma. The treat­ment, known as mel­phalan-flufenamide or J1, is being devel­oped by the Swedish pharma­ceu­tical com­pany Oncopeptides and consists of melphalan (Alkeran) 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. Specifically, the results showed that  melphalan-flufenamide ef­fec­tively killed myeloma cells that were resistant to Velcade (bor­tez­o­mib) and mel­phalan alone. The re­searchers found that even low doses of mel­phalan-flufenamide were ef­fec­tive and should be safer than the doses of mel­phalan cur­rent used to treat myeloma. For more in­for­ma­tion, please refer to the study in Clinical Cancer Research (abstract).

Clinical Trial To Study WT1 Vaccine In Multiple Myeloma Patients – The Memorial Sloan-Kettering Cancer Center has launched a pilot trial to study the Wilms Tumor 1 (WT1) vaccine in mul­ti­ple myeloma patients who just re­ceived a stem cell trans­plant. WT1 is a pro­tein that is often present in myeloma cells. The goal of the study is to de­ter­mine whether the vaccine activates the patient’s immune sys­tem against myeloma cells with WT1. Eligible patients must be at least 18 years old, have WT1-positive myeloma, and be eli­gible to undergo an au­tol­o­gous stem cell trans­plant. For more in­for­ma­tion on the trial, please see the clinical trial description.