@article{3004433,
    title = "Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure",
    author = "Wang, M. and Dimopoulos, M.A. and Chen, C. and Cibeira, M.T. and Attal, M. and Spencer, A. and Rajkumar, S.V. and Yu, Z. and Olesnyckyj, M. and Zeldis, J.B. and Knight, R.D. and Weber, D.M.",
    journal = "Blood advances",
    year = "2008",
    volume = "112",
    number = "12",
    pages = "4445-4451",
    publisher = "American Society of Hematology",
    doi = "10.1182/blood-2008-02-141614",
    keywords = "bortezomib;  dexamethasone;  lenalidomide;  placebo;  thalidomide;  vincristine;  antineoplastic agent;  dexamethasone;  drug derivative;  lenalidomide;  thalidomide, adult;  anemia;  article;  bone marrow suppression;  cancer relapse;  cancer survival;  clinical assessment;  clinical trial;  controlled clinical trial;  controlled study;  deep vein thrombosis;  disease duration;  drug dose reduction;  drug efficacy;  fatigue;  febrile neutropenia;  gastrointestinal symptom;  human;  infection;  lung embolism;  major clinical study;  multiple myeloma;  neutropenia;  peripheral neuropathy;  priority journal;  progression free survival;  prospective study;  therapy effect;  thrombocytopenia;  treatment response;  adjuvant chemotherapy;  dose response;  drug effect;  drug resistance;  evaluation;  middle aged;  mortality;  multicenter study;  multiple myeloma;  phase 3 clinical trial;  randomized controlled trial;  recurrent disease;  retrospective study;  survival;  treatment outcome, Antineoplastic Combined Chemotherapy Protocols;  Chemotherapy, Adjuvant;  Clinical Trials, Phase III as Topic;  Dexamethasone;  Dose-Response Relationship, Drug;  Drug Resistance, Neoplasm;  Humans;  Middle Aged;  Multiple Myeloma;  Placebos;  Randomized Controlled Trials as Topic;  Recurrence;  Retrospective Studies;  Survival Analysis;  Thalidomide;  Treatment Outcome",
    abstract = "This analysis assessed the efficacy and safety of lenalidomide + dexamethasone in patients with relapsed or refractory multiple myeloma (MM) previously treated with thalidomide. Of 704 patients, 39% were thalidomide exposed. Thalidomide-exposed patients had more prior lines of therapy and longer duration of myeloma than thalidomide-naive patients. Lenalidomide + dexamethasone led to higher overall response rate (ORR), longer time to progression (TTP), and progression-free survival (PFS) versus placebo + dexamethasone despite prior thalidomide exposure. Among lenalidomide + dexamethasone-treated patients, ORR was higher in thalidomide-naive versus thalidomide-exposed patients (P = .04), with longer median TTP (P = .04) and PFS (P = .02). Likewise for dexamethasone alone-treated patients (P = .03 for ORR, P = .03 for TTP, P = .06 for PFS). Prior thalidomide did not affect survival in lenalidomide + dexamethasone-treated patients (36.1 vs 33.3 months, P > .05). Thalidomide-naive and thalidomide-exposed patients had similar toxicities. Lenalidomide + dexamethasone resulted in higher rates of venous thromboembolism, myelosuppression, and infections versus placebo + dexamethasone, independent of prior thalidomide exposure. Lenalidomide + dexamethasone was superior to placebo + dexamethasone, independent of prior thalidomide exposure. Although prior thalidomide may have contributed to inferior TTP and PFS compared with thalidomide-naive patients, these parameters remained superior compared with placebo + dexamethasone; similar benefits compared with placebo + dexamethasone were not evident for thalidomide-exposed patients in terms of overall survival. Studies were registered at http://www.clinicaltrials. gov under NCT00056160 and NCT00424047. © 2008 by The American Society of Hematology."
}