title: Thromboembolic events with lenalidomide-based therapy for multiple myeloma.
abstract: BACKGROUND
  The purpose was to evaluate the incidence and risk factors of thromboembolism associated with lenalidomide therapy in newly diagnosed myeloma.
  
  
  METHODS
  A pooled analysis was performed of patients with previously untreated multiple myeloma enrolled in clinical trials of lenalidomide-based therapy at the Mayo Clinic, Rochester, Minnesota, and the Italian Myeloma Network, Italy. The incidence of thrombosis, the effect of risk factors such as steroid dose and erythropoietin supplementation, and the effect of prophylaxis were examined.
  
  
  RESULTS
  In all, 125 patients enrolled in 3 clinical trials were identified. Patients were stratified based on the concomitant corticosteroid dose. Fifty-two patients were in the high-dose group (dexamethasone 40 mg, 12 days a month); 73 patients were in the low-dose group (prednisone at any dose; or dexamethasone 40 mg, 4 days a month). A total of 110 patients were initiated on thromboprophylaxis; of these, 104 patients (95%) received aspirin. Ten patients (8%) developed deep vein thrombosis, including 4 who were not receiving any thromboprophylaxis at the time of the event. The rate of thromboembolic events was not different between patients who received concomitant erythropoietin therapy and those who did not, 4.8% and 8.6%, respectively (P= .54). A higher number of venous thrombotic episodes occurred in the high-dose corticosteroid group compared with the low-dose corticosteroid therapy group (12% vs 6%), but the difference was not statistically significant (P= .3).
  
  
  CONCLUSIONS
  The incidence of deep vein thrombosis is lower than previously reported in the literature. There was a trend to a higher incidence of thrombosis in patients receiving high-dose corticosteroid therapy.
authors.affiliation: Division of Hematology, Department of Internal Medicine, Mayo Clinic College of Medicine, Rochester, Minnesota 55905, USA.
authors.forename: Smitha Patiyil
authors.initials: SP
authors.lastname: Menon
authors.forename: S Vincent
authors.initials: SV
authors.lastname: Rajkumar
authors.forename: Martha
authors.initials: M
authors.lastname: Lacy
authors.forename: Patrizia
authors.initials: P
authors.lastname: Falco
authors.forename: Antonio
authors.initials: A
authors.lastname: Palumbo
mesh_terms: D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000009:adverse effects; D003907:Dexamethasone / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D006801:Humans; D015994:Incidence; D000077269:Lenalidomide; D008297:Male; D008558:Melphalan / Q000627:therapeutic use; D008875:Middle Aged; D009101:Multiple Myeloma / Q000150:complications / Q000188:drug therapy*; D019653:Myeloablative Agonists / Q000627:therapeutic use; D011241:Prednisone / Q000627:therapeutic use; D012307:Risk Factors; D015996:Survival Rate; D013792:Thalidomide / Q000009:adverse effects / Q000031:analogs & derivatives*; D020246:Venous Thrombosis / Q000139:chemically induced* / Q000517:prevention & control
chemical_list: D000893:Anti-Inflammatory Agents; D000970:Antineoplastic Agents; D005343:Fibrinolytic Agents; D019653:Myeloablative Agonists; D013792:Thalidomide; D003907:Dexamethasone; D000077269:Lenalidomide; D008558:Melphalan; D011241:Prednisone