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

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

doi:10.1182/blood-2010-02-268862

Cited by 861Multiple Myeloma Research and TreatmentsBone health and treatmentsProtein Degradation and Inhibitors

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

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Richardson, Paul G., Weller, Edie, Lonial, Sagar, Jakubowiak, Andrzej J., Jagannath, Sundar, Raje, Noopur S., Avigan, David E., Xie, Wanling +17 more·2010·Blood

DOI 10.1182/blood-2010-02-268862PMC PMC3324254

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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/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.

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Authors: Richardson, P. G., Weller, E., Lonial, S., Jakubowiak, A. J., Jagannath, S., Raje, N. S., Avigan, D. E., Xie, W., Ghobrial, I. M., Schlossman, R. L., Mazumder, A., Munshi, N. C., Vesole, D. H., Joyce, R., Kaufman, J. L., Doss, D., Warren, D. L., Lunde, L. E., Kaster, S., DeLaney, C., Hideshima, T., Mitsiades, C. S., Knight, R., Esseltine, D.-L., & Anderson, K. C.
Affiliations: Dana-Farber Cancer Institute (US)
Emory University (US)
University of Michigan (US)
Saint Vincent's Catholic Medical Center (US)
Massachusetts General Hospital (US)
Beth Israel Deaconess Medical Center (US)
Celgene (United States) (US)
Takeda Oncology (United States) (US)
ORCID: Richardson, Paul G.
Weller, Edie
Lonial, Sagar
Jakubowiak, Andrzej J.
Jagannath, Sundar
Raje, Noopur S.
Avigan, David E.
Xie, Wanling
Ghobrial, Irene M.
Munshi, Nikhil C.
Vesole, David H.
Joyce, Robin
Kaufman, Jonathan L.
Hideshima, Teru
Mitsiades, Constantine S.
Knight, Robert
Anderson, Kenneth C.
Venue: Blood
Publisher: American Society of Hematology
Published: 2010-08-05
Volume: 116
Issue: 5
Pages: 679-686
ISSN: 0006-4971 (ISSN-L)
1528-0020
DOI: 10.1182/blood-2010-02-268862
PMC: PMC3324254
OpenAlex: W1969648097
Cited by: 861
References: 54
Citations by year: 2026: 9 · 2025: 28 · 2024: 21 · 2023: 19 · 2022: 37 · 2021: 44 · 2020: 42 · 2019: 37 · 2018: 50 · 2017: 66 · 2016: 74 · 2015: 59 · 2014: 81 · 2013: 111 · 2012: 86
FWCI: 57.85
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: Blood (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Funders: National Institutes of Health (5p01ca078378-15)
Takeda Oncology
National Cancer Institute (P01-CA078378, P50CA100707)
Topics: Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
Health Sciences › Medicine › Oncology › Bone health and treatments
Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein Degradation and Inhibitors
Keywords: lenalidomide, bortezomib, dexamethasone, multiple myeloma, newly diagnosed multiple myeloma, first-line therapy, combination chemotherapy, maintenance therapy, autologous stem cell transplantation, sensory neuropathy, hematologic toxicity, progression-free survival, overall survival
MeSH terms: Bortezomib, Lenalidomide, Antineoplastic Combined Chemotherapy Protocols, Boronic Acids, Combined Modality Therapy, Dexamethasone, Fatigue, Hematologic Diseases, Humans, Multiple Myeloma, Pain, Pyrazines, Remission Induction, Sensation Disorders, Thalidomide, Survival Analysis, Treatment Outcome, Stem Cell Transplantation

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

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