Lenalidomide, bortezomib, and dexamethasone combination therapy in patients with newly diagnosed multiple myeloma - PubMed (original) (raw)
Clinical Trial
. 2010 Aug 5;116(5):679-86.
doi: 10.1182/blood-2010-02-268862. Epub 2010 Apr 12.
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 Delaney, Teru Hideshima, Constantine S Mitsiades, Robert Knight, Dixie-Lee Esseltine, Kenneth C Anderson
Affiliations
- PMID: 20385792
- PMCID: PMC3324254
- DOI: 10.1182/blood-2010-02-268862
Clinical Trial
Lenalidomide, bortezomib, and dexamethasone combination therapy in patients with newly diagnosed multiple myeloma
Paul G Richardson et al. Blood. 2010.
Abstract
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/m(2) (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/m(2), 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.
Figures
Figure 1
Kaplan-Meier estimate for PFS among all patients treated with lenalidomide-bortezomib-dexamethasone with/without ASCT (N = 66). Dashed lines indicate 95% CIs.
Figure 2
Kaplan-Meier estimate for PFS according to receipt of ASCT, from 1 year after treatment initiation.
References
- Harousseau JL, Attal M, Avet-Loiseau H. The role of complete response in multiple myeloma. Blood. 2009;114(15):3139–3146. - PubMed
- Kyle RA, Leong T, Li S, et al. Complete response in multiple myeloma: clinical trial E9486, an Eastern Cooperative Oncology Group study not involving stem cell transplantation. Cancer. 2006;106(9):1958–1966. - PubMed
- van de Velde H, Liu X, Chen G, et al. Complete response correlates with long-term survival and progression-free survival in high-dose therapy in multiple myeloma. Haematologica. 2007;92(10):1399–1406. - PubMed
- Kastritis E, Zervas K, Symeonidis A, et al. Improved survival of patients with multiple myeloma after the introduction of novel agents and the applicability of the International Staging System (ISS): an analysis of the Greek Myeloma Study Group (GMSG). Leukemia. 2009;23(6):1152–1157. - PubMed
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