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Lenalidomide Maintenance after Stem-Cell Transplantation for Multiple Myeloma
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BACKGROUND: High-dose chemotherapy with autologous stem-cell transplantation is a standard treatment for young patients with multiple myeloma. Residual disease is almost always present after transplantation and is responsible for relapse. This phase 3, placebo-controlled trial investigated the efficacy of lenalidomide maintenance therapy after transplantation. METHODS: We randomly assigned 614 patients younger than 65 years of age who had nonprogressive disease after first-line transplantation to maintenance treatment with either lenalidomide (10 mg per day for the first 3 months, increased to 15 mg if tolerated) or placebo until relapse. The primary end point was progression-free survival. RESULTS: Lenalidomide maintenance therapy improved median progression-free survival (41 months, vs. 23 months with placebo; hazard ratio, 0.50; P<0.001). This benefit was observed across all patient subgroups, including those based on the β(2)-microglobulin level, cytogenetic profile, and response after transplantation. With a median follow-up period of 45 months, more than 70% of patients in both groups were alive at 4 years. The rates of grade 3 or 4 peripheral neuropathy were similar in the two groups. The incidence of second primary cancers was 3.1 per 100 patient-years in the lenalidomide group versus 1.2 per 100 patient-years in the placebo group (P=0.002). Median event-free survival (with events that included second primary cancers) was significantly improved with lenalidomide (40 months, vs. 23 months with placebo; P<0.001). CONCLUSIONS: Lenalidomide maintenance after transplantation significantly prolonged progression-free and event-free survival among patients with multiple myeloma. Four years after randomization, overall survival was similar in the two study groups. (Funded by the Programme Hospitalier de Recherche Clinique and others; ClinicalTrials.gov number, NCT00430365.).
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“Lenalidomide is the standard of care for maintenance therapy for most patients.142–147”
From Multiple myeloma: 2024 update on diagnosis, risk-stratification, and management (2024) · cites this paper as [142]
Experimental — accuracy not yet measuredIn the citing paper
“Patients who have disease progression while not on treatment with lenalidomide can often be re-treated effectively with this agent37,38, sometimes multiple times, and typically in combination with proteasome inhibitors such as carfilzomib39 and ixazomib40 or with daratumumab41.”
From Cancer therapies based on targeted protein degradation — lessons learned with lenalidomide (2021) · cites this paper as [38]
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Metadata
- Authors
- Attal, M., Lauwers-Cances, V., Marit, G., Caillot, D., Moreau, P., Facon, T., Stoppa, A. M., Hulin, C., Benboubker, L., Garderet, L., Decaux, O., Leyvraz, S., Vekemans, M.-C., Voillat, L., Michallet, M., Pegourie, B., Dumontet, C., Roussel, M., Leleu, X., Mathiot, C., Payen, C., Avet-Loiseau, H., & Harousseau, J.-L.
- Affiliations
- Hôpital Purpan (FR)
- CHU Dijon Bourgogne (FR)
- Hôpital Claude Huriez (FR)
- Institut Paoli-Calmettes (FR)
- Centre Hospitalier Régional et Universitaire de Nancy (FR)
- Hôpital Saint-Antoine (FR)
- Hôpital Pontchaillou (FR)
- Centre Hospitalier Universitaire Vaudois (CH)
- Centre Hospitalier Universitaire de Besançon (FR)
- Hôpital Edouard Herriot (FR)
- Institut Curie (FR)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2012-05-10
- Volume
- 366
- Issue
- 19
- Pages
- 1782-1791
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2128084036
- Semantic Scholar
- c28c0ef900dcfd0347dbf26ecd97d5547f948a9a
- Cited by
- 1,155
- References
- 24
- Citations by year
- 2026: 32 · 2025: 36 · 2024: 43 · 2023: 61 · 2022: 70 · 2021: 85 · 2020: 79 · 2019: 68 · 2018: 83 · 2017: 98 · 2016: 108 · 2015: 86 · 2014: 102 · 2013: 133 · 2012: 68
- FWCI
- 82.78
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- HAL (submittedVersion)
- Digital Access to Libraries (submittedVersion)
- Dépôt institutionnel de l'Université libre de Bruxelles (Université Libre de Bruxelles) (submittedVersion)
- IRIS (submittedVersion)
- SERVAL (Université de Lausanne) (submittedVersion)
- Topics
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Health Sciences › Medicine › Clinical Neurology › Multiple Sclerosis Research Studies
- Keywords
- lenalidomide, maintenance therapy, multiple myeloma, autologous stem cell transplantation, progression-free survival, event-free survival, secondary malignancies, peripheral neuropathy, young patients, residual disease
- MeSH terms
- Lenalidomide, Adult, Aged, Antineoplastic Agents, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle Aged, Multiple Myeloma, Thalidomide, Neoplasms, Second Primary, Disease-Free Survival, Stem Cell Transplantation, Kaplan-Meier Estimate, Young Adult, Maintenance Chemotherapy
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