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Blood, 1 December 2008, Vol. 112, No. 12, pp. 4445-4451.
Prepublished online as a Blood First Edition Paper on September 17, 2008; DOI 10.1182/blood-2008-02-141614.
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Submitted February 26, 2008
Accepted July 25, 2008
Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure
Michael Wang*, Meletios A. Dimopoulos, Christine Chen, M. Teresa Cibeira, Michel Attal, Andrew Spencer, S. Vincent Rajkumar, Zhinuan Yu, Marta Olesnyckyj, Jerome B Zeldis, Robert D Knight, and Donna M Weber
Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston, TX, United States
Department of Clinical Therapeutics, University of Athens School of Medicine, Athens, Greece
Department of Medicine, Princess Margaret Hospital, Toronto, ON, Canada
Hematology Department, Institute of Hematology and Oncology, Hospital Clinic, IDIBAPS, University of Barcelona, Barcelona, Spain
Division of Hematology, Centre Hospitalier Universite de Purpan, Toulouse, France
Department of Malignant Hematology and Stem Cell Transplantation Service, The Alfred Hospital, Melbourne, Australia
Mayo Clinic Cancer Center, Rochester, MN, United States
Celgene Corporation, Summit, NJ, United States
* Corresponding author; email: miwang{at}mdanderson.org.
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. In conclusion, lenalidomide+dexamethasone was superior to placebo+dexamethasone in relapsed or refractory MM, 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 www.clinicaltrials.gov under: NCT00056160 and NCT00424047.
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