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: Attal, Michel
Caillot, Denis
Moreau, Philippe
Facon, Thierry
Hulin, Cyrille
Garderet, Laurent
Decaux, Olivier
Leyvraz, Serge
Vekemans, Marie-Christiane
Michallet, Mauricette
Dumontet, Charles
Roussel, Murielle
Leleu, Xavier
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: 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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