Lenalidomide, bortezomib, and dexamethasone combination therapy in patients with newly diagnosed multiple myeloma

Paul G. Richardson, Edie Weller, Sagar Lonial, Andrzej J. Jakubowiak, Sundar Jagannath, Noopur S. Raje, David E. Avigan, Wanling Xie, Irene M. Ghobrial, Robert L. Schlossman, Amitabha Mazumder, Nikhil C. Munshi, David H. Vesole, Robin Joyce, Jonathan L. Kaufman, Deborah Doss, Diane L. Warren, Laura E. Lunde, Sarah Kaster, Carol DeLaneyTeru Hideshima, Constantine S. Mitsiades, Robert Knight, Dixie Lee Esseltine, Kenneth C. Anderson

Research output: Contribution to journalArticlepeer-review

733 Scopus citations


This phase 1/2 study is the first prospective evaluation of lenalidomide-bortezomib-dexamethasone in front-line myeloma. Patients (N = 66) received 3-week cycles (n = 8) of bortezomib 1.0 or 1.3 mg/m2 (days 1, 4, 8, 11), lenalidomide 15 to 25 mg (days 1-14), and dexamethasone 40 or 20 mg (days 1, 2, 4, 5, 8, 9, 11, 12). Responding patients proceeded to maintenance or transplantation. Phase 2 dosing was determined to be bortezomib 1.3 mg/m2, lenalidomide 25 mg, and dexamethasone 20 mg. Most common toxicities included sensory neuropathy (80%) and fatigue (64%), with only 27%/2% and 32%/3% grade 2/3, respectively. In addition, 32% reported neuropathic pain (11%/3%, grade 2/3). Grade 3/4 hematologic toxicities included lymphopenia (14%), neutropenia (9%), and thrombocytopenia (6%). Thrombosis was rare (6% overall), and no treatment-related mortality was observed. Rate of partial response was 100% in both the phase 2 population and overall, with 74% and 67% each achieving very good partial response or better. Twenty-eight patients (42%) proceeded to undergo transplantation. With median follow-up of 21 months, estimated 18-month progression-free and overall survival for the combination treatment with/without transplantation were 75% and 97%, respectively. Lenalidomide-bortezomib-dexamethasone demonstrates favorable tolerability and is highly effective in the treatment of newly diagnosed myeloma. This study is registered at http://clinicaltrials.gov as NCT00378105.

Original languageEnglish
Pages (from-to)679-686
Number of pages8
Issue number5
StatePublished - 5 Aug 2010
Externally publishedYes


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