Lenalidomide Maintenance After Autologous Stem-Cell Transplantation in Newly Diagnosed Multiple Myeloma: A Meta-Analysis
Open accessAbstract
Purpose Lenalidomide maintenance therapy after autologous stem-cell transplantation (ASCT) demonstrated prolonged progression-free survival (PFS) versus placebo or observation in several randomized controlled trials (RCTs) of patients with newly diagnosed multiple myeloma (NDMM). All studies had PFS as the primary end point, and none were powered for overall survival (OS) as a primary end point. Thus, a meta-analysis was conducted to better understand the impact of lenalidomide maintenance in this setting. Patients and Methods The meta-analysis was conducted using primary-source patient-level data and documentation from three RCTs (Cancer and Leukemia Group B 100104, Gruppo Italiano Malattie Ematologiche dell'Adulto RV-MM-PI-209, and Intergroupe Francophone du Myélome 2005-02) that met the following prespecified inclusion criteria: an RCT in patients with NDMM receiving ASCT followed by lenalidomide maintenance versus placebo or observation with patient-level data available and achieved database lock for primary efficacy analysis. Results Overall, 1,208 patients were included in the meta-analysis (605 patients in the lenalidomide maintenance group and 603 in the placebo or observation group). The median PFS was 52.8 months for the lenalidomide group and 23.5 months for the placebo or observation group (hazard ratio, 0.48; 95% CI, 0.41 to 0.55). At a median follow-up time of 79.5 months for all surviving patients, the median OS had not been reached for the lenalidomide maintenance group, whereas it was 86.0 months for the placebo or observation group (hazard ratio, 0.75; 95% CI, 0.63 to 0.90; P = .001). The cumulative incidence rate of a second primary malignancy before disease progression was higher with lenalidomide maintenance versus placebo or observation, whereas the cumulative incidence rates of progression, death, or death as a result of myeloma were all higher with placebo or observation versus lenalidomide maintenance. Conclusion This meta-analysis demonstrates a significant OS benefit and confirms the PFS benefit with lenalidomide maintenance after ASCT in patients with NDMM when compared with placebo or observation.
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There is an increased risk for the development of both secondary hematologic and solid organ cancers, especially in post-transplant maintenance with lenalidomide.
“There is an increased risk for the development of both secondary hematologic and solid organ cancers, especially in post-transplant maintenance with lenalidomide [56].”
From Epidemiology, Staging, and Management of Multiple Myeloma (2021) · cites this paper as [56]
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Self-citationLenalidomide Maintenance after Stem-Cell Transplantation for Multiple Myeloma
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Self-citationLenalidomide after Stem-Cell Transplantation for Multiple Myeloma
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“There is an increased risk for the development of both secondary hematologic and solid organ cancers, especially in post-transplant maintenance with lenalidomide [56].”
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- Authors
- McCarthy, P. L., Holstein, S. A., Petrucci, M. T., Richardson, P. G., Hulin, C., Tosi, P., Bringhen, S., Musto, P., Anderson, K. C., Caillot, D., Gay, F., Moreau, P., Marit, G., Jung, S.-H., Yu, Z., Winograd, B., Knight, R. D., Palumbo, A., & Attal, M.
- Affiliations
- Roswell Park Comprehensive Cancer Center (US)
- Philip L. McCarthy, Roswell Park Cancer Institute, Buffalo, NY; Sarah A. Holstein, University of Nebraska Medical Center, Omaha, NE; Maria Teresa Petrucci, University La Sapienza; Antonio Palumbo, Takeda Italia, Rome; Patrizia Tosi, Rimini Hospital, Rimini; Sara Bringhen and Francesca Gay, University of Torino, Torino; Pellegrino Musto, Cancer Institute for Research and Care and The Referral Cancer Center of Basilicata, Rionero in Vulture, Italy; Paul G. Richardson and Kenneth C. Anderson, Dana-Farber...
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2017-10-10
- Volume
- 35
- Issue
- 29
- Pages
- 3279-3289
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- PMC
- PMC5652871
- OpenAlex
- W2737964630
- Cited by
- 698
- References
- 4
- Citations by year
- 2026: 44 · 2025: 51 · 2024: 57 · 2023: 90 · 2022: 79 · 2021: 94 · 2020: 117 · 2019: 79 · 2018: 68 · 2017: 16
- FWCI
- 12.08
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- Journal of Clinical Oncology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Institutional Research Information System University of Turin (University of Turin) (submittedVersion, other-oa)
- HAL (submittedVersion)
- CINECA IRIS Institutional Research Information System (University of Bari Aldo Moro) (submittedVersion)
- Funders
- Celgene
- National Cancer Institute (U10CA180882, U10CA180821)
- 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, maintenance therapy, autologous stem cell transplantation, newly diagnosed multiple myeloma, progression-free survival, overall survival, second primary malignancy, individual patient data
- MeSH terms
- Lenalidomide, Adult, Aged, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Multiple Myeloma, Risk Factors, Thalidomide, Time Factors, Transplantation, Autologous, Randomized Controlled Trials as Topic, Treatment Outcome, Chemotherapy, Adjuvant, Disease Progression, Disease-Free Survival, Angiogenesis Inhibitors, Stem Cell Transplantation, Kaplan-Meier Estimate, Young Adult, Maintenance Chemotherapy
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