title: Survival effect of venous thromboembolism in patients with multiple myeloma treated with lenalidomide and high-dose dexamethasone.
abstract: PURPOSE We conducted a retrospective analysis of the survival effect of venous thromboembolism (VTE) development in patients with multiple myeloma (MM). METHODS Two identically designed, multicenter, double-blind, phase III clinical trials (MM-009 and MM-010) were conducted in Europe and the United States to assess the effect of lenalidomide in combination with dexamethasone versus dexamethasone plus placebo in patients with relapsed or refractory MM, after failing at least one prior line of treatment. In this retrospective analysis, we evaluated incidence and survival effect of thromboembolism in 353 patients randomly assigned to receive 25 mg of lenalidomide on days 1 through 21 of a 28-day cycle, plus 40 mg of oral dexamethasone on days 1 through 4, 9 through 12, and 17 through 20 for the first four cycles; after the fourth cycle, 40 mg of dexamethasone was administered on days 1 through 4 only. Results Seventeen percent of patients experienced a thromboembolic episode. The development of VTE did not significantly affect overall survival (P = .90) or time to progression (P = .34). No significant survival impact was observed in a subgroup of patients who received prophylactic anticoagulation (overall survival P = .7, time to progression P = .1). CONCLUSION Patients with MM treated with lenalidomide and high-dose dexamethasone who developed a VTE did not experience shorter overall survival or time to progression.
authors.affiliation: Division of Hematology, Blood/Marrow Transplant and Myeloma Program, 30 N 1900 E, 5C402, University of Utah, Salt Lake City, UT 84132, USA. maurizio.zangari@hsc.utah.edu
authors.forename: Maurizio
authors.initials: M
authors.lastname: Zangari
authors.forename: Guido
authors.initials: G
authors.lastname: Tricot
authors.forename: Latha
authors.initials: L
authors.lastname: Polavaram
authors.forename: Fenghuang
authors.initials: F
authors.lastname: Zhan
authors.forename: Ashlie
authors.initials: A
authors.lastname: Finlayson
authors.forename: Robert
authors.initials: R
authors.lastname: Knight
authors.forename: Tommy
authors.initials: T
authors.lastname: Fu
authors.forename: Donna
authors.initials: D
authors.lastname: Weber
authors.forename: Meletios A
authors.initials: MA
authors.lastname: Dimopoulos
authors.forename: Ruben
authors.initials: R
authors.lastname: Niesvizky
authors.forename: Louis
authors.initials: L
authors.lastname: Fink
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D003907:Dexamethasone / Q000008:administration & dosage*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives*; D054556:Venous Thromboembolism / Q000401:mortality*
chemical_list: D000970:Antineoplastic Agents; D013792:Thalidomide; D003907:Dexamethasone; D000077269:Lenalidomide