Combination therapy with lenalidomide plus dexamethasone (Rev/Dex) for newly diagnosed myeloma
Open accessAbstract
We report the results of a phase 2 trial using lenalidomide plus dexamethasone (Rev/Dex) as initial therapy for myeloma. Thirtyfour patients were enrolled. Lenalidomide was given orally 25 mg daily on days 1 to 21 of a 28-day cycle. Dexamethasone was given orally 40 mg daily on days 1 to 4, 9 to 12, and 17 to 20 of each cycle. Objective response was defined as a decrease in serum monoclonal protein level by 50% or greater and a decrease in urine M protein level by at least 90% or to a level less than 200 mg/24 hours, confirmed by 2 consecutive determinations at least 4 weeks apart. Thirty-one of 34 patients achieved an objective response, including 2 (6%) achieving complete response (CR) and 11 (32%) meeting criteria for both very good partial response and near complete response, resulting in an overall objective response rate of 91%. Of the 3 remaining patients not achieving an objective response, 2 had minor response (MR) and one had stable disease. Fortyseven percent of patients experienced grade III or higher nonhematologic toxicity, most commonly fatigue (15%), muscle weakness (6%), anxiety (6%), pneumonitis (6%), and rash (6%). Rev/Dex is a highly active regimen with manageable side effects in the treatment of newly diagnosed myeloma.
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Thalidomide maintenance increased complete remission rates (62% versus 43%; P<0.001) and event-free survival (56% versus 44% at 5 years; P=0.01), but produced no overall survival benefit (5-year OS about 65% in both groups; P=0.90).
“Such maintenance therapy was first attempted with thalidomide, resulting in an increase in complete remission (CR) rates (62% versus 43% without maintenance; P <0.001) and an event-free survival (EFS) benefit (56% versus 44% at 5 years; P = 0.01), but no overall survival (OS) benefit (5-year OS ~65% in both groups; P = 0.90)32.”
From Cancer therapies based on targeted protein degradation — lessons learned with lenalidomide (2021) · cites this paper as [32]
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- Authors
- Rajkumar, S. V., Hayman, S. R., Lacy, M. Q., Dispenzieri, A., Geyer, S. M., Kabat, B., Zeldenrust, S. R., Kumar, S., Greipp, P. R., Fonseca, R., Lust, J. A., Russell, S. J., Kyle, R. A., Witzig, T. E., & Gertz, M. A.
- Affiliations
- Mayo Clinic (US)
- From the Divisions of Hematology and Biostatistics, Mayo Clinic, Rochester, MN; and the Division of Hematology/Oncology, Mayo Clinic, Scottsdale, AZ.
- ORCID
- Venue
- Blood
- Publisher
- American Society of Hematology
- Published
- 2005-12-15
- Volume
- 106
- Issue
- 13
- Pages
- 4050-4053
- ISSN
- 0006-4971 (ISSN-L)
- 1528-0020
- PMC
- PMC1895238
- OpenAlex
- W2168929741
- Cited by
- 648
- References
- 21
- Citations by year
- 2026: 8 · 2025: 8 · 2024: 14 · 2023: 7 · 2022: 17 · 2021: 12 · 2020: 18 · 2019: 8 · 2018: 14 · 2017: 16 · 2016: 18 · 2015: 19 · 2014: 16 · 2013: 39 · 2012: 39
- FWCI
- 47.43
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Blood (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Cancer Institute (CA10080, R01CA093842, CA 93842, R01CA107476)
- Topics
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Health Sciences › Medicine › Genetics › Chronic Lymphocytic Leukemia Research
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Keywords
- lenalidomide, dexamethasone, multiple myeloma, newly diagnosed multiple myeloma, combination therapy, initial treatment, objective response rate, complete response, non-hematologic toxicity, fatigue, pneumonitis, monoclonal protein
- MeSH terms
- Lenalidomide, Adult, Aged, Dexamethasone, Drug Therapy, Combination, Female, Hematologic Tests, Humans, Male, Middle Aged, Multiple Myeloma, Thalidomide, Survival Rate
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