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Cited by 1,155Multiple Myeloma Research and TreatmentsBone health and treatmentsMultiple Sclerosis Research Studies

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Lenalidomide Maintenance after Stem-Cell Transplantation for Multiple Myeloma

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Attal, Michel, Lauwers-Cances, Valerie, Marit, Gerald, Caillot, Denis, Moreau, Philippe, Facon, Thierry, Stoppa, Anne Marie, Hulin, Cyrille, Benboubker, Lofti, Garderet, Laurent, Decaux, Olivier, Leyvraz, Serge, Vekemans, Marie-Christiane, Voillat, Laurent, Michallet, Mauricette, Pegourie, Brigitte, Dumontet, Charles, Roussel, Murielle, Leleu, Xavier, Mathiot, Claire, Payen, Catherine, Avet-Loiseau, Hervé, Harousseau, Jean-Luc·2012·New England Journal of Medicine
DOI 10.1056/nejmoa1114138
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Abstract

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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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
DOI
10.1056/nejmoa1114138
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
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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