TY - JOUR
TI - Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure
AU - Wang, M.
AU - Dimopoulos, M.A.
AU - Chen, C.
AU - Cibeira, M.T.
AU - Attal, M.
AU - Spencer, A.
AU - Rajkumar, S.V.
AU - Yu, Z.
AU - Olesnyckyj, M.
AU - Zeldis, J.B.
AU - Knight, R.D.
AU - Weber, D.M.
JO - Blood advances
PY - 2008
VL - 112
TODO - 12
SP - 4445-4451
PB - American Society of Hematology
SN - null
TODO - 10.1182/blood-2008-02-141614
TODO - 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
TODO - 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.
ER -