Cited by 1,147Multiple Myeloma Research and TreatmentsBone health and treatmentsProtein Degradation and Inhibitors

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Lenalidomide after Stem-Cell Transplantation for Multiple Myeloma

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McCarthy, Philip L., Owzar, Kouros, Hofmeister, Craig C., Hurd, David D., Hassoun, Hani, Richardson, Paul G., Giralt, Sergio, Stadtmauer, Edward A., Weisdorf, Daniel J., Vij, Ravi, Moreb, Jan S., Callander, Natalie Scott, Van Besien, Koen, Gentile, Teresa, Isola, Luis, Maziarz, Richard T., Gabriel, Don A., Bashey, Asad, Landau, Heather, Martin, Thomas, Qazilbash, Muzaffar H., Levitan, Denise, McClune, Brian, Schlossman, Robert, Hars, Vera, Postiglione, John, Jiang, Chen, Bennett, Elizabeth, Barry, Susan, Bressler, Linda, Kelly, Michael, Seiler, Michele, Rosenbaum, Cara, Hari, Parameswaran, Pasquini, Marcelo C., Horowitz, Mary M., Shea, Thomas C., Devine, Steven M., Anderson, Kenneth C., Linker, Charles·2012·New England Journal of Medicine

DOI 10.1056/nejmoa1114083PMC PMC3744390

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Abstract

BACKGROUND: Data are lacking on whether lenalidomide maintenance therapy prolongs the time to disease progression after autologous hematopoietic stem-cell transplantation in patients with multiple myeloma. METHODS: Between April 2005 and July 2009, we randomly assigned 460 patients who were younger than 71 years of age and had stable disease or a marginal, partial, or complete response 100 days after undergoing stem-cell transplantation to lenalidomide or placebo, which was administered until disease progression. The starting dose of lenalidomide was 10 mg per day (range, 5 to 15). RESULTS: The study-drug assignments were unblinded in 2009, when a planned interim analysis showed a significantly longer time to disease progression in the lenalidomide group. At unblinding, 20% of patients who received lenalidomide and 44% of patients who received placebo had progressive disease or had died (P<0.001); of the remaining 128 patients who received placebo and who did not have progressive disease, 86 crossed over to lenalidomide. At a median follow-up of 34 months, 86 of 231 patients who received lenalidomide (37%) and 132 of 229 patients who received placebo (58%) had disease progression or had died. The median time to progression was 46 months in the lenalidomide group and 27 months in the placebo group (P<0.001). A total of 35 patients who received lenalidomide (15%) and 53 patients who received placebo (23%) died (P=0.03). More grade 3 or 4 hematologic adverse events and grade 3 nonhematologic adverse events occurred in patients who received lenalidomide (P<0.001 for both comparisons). Second primary cancers occurred in 18 patients who received lenalidomide (8%) and 6 patients who received placebo (3%). CONCLUSIONS: Lenalidomide maintenance therapy, initiated at day 100 after hematopoietic stem-cell transplantation, was associated with more toxicity and second cancers but a significantly longer time to disease progression and significantly improved overall survival among patients with myeloma. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00114101.).

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Authors: McCarthy, P. L., Owzar, K., Hofmeister, C. C., Hurd, D. D., Hassoun, H., Richardson, P. G., Giralt, S., Stadtmauer, E. A., Weisdorf, D. J., Vij, R., Moreb, J. S., Callander, N. S., Van Besien, K., Gentile, T., Isola, L., Maziarz, R. T., Gabriel, D. A., Bashey, A., Landau, H., Martin, T., Qazilbash, M. H., Levitan, D., McClune, B., Schlossman, R., Hars, V., Postiglione, J., Jiang, C., Bennett, E., Barry, S., Bressler, L., Kelly, M., Seiler, M., Rosenbaum, C., Hari, P., Pasquini, M. C., Horowitz, M. M., Shea, T. C., Devine, S. M., Anderson, K. C., & Linker, C.
Affiliations: Roswell Park Comprehensive Cancer Center (US)
The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (US)
Duke University (US)
Memorial Sloan Kettering Cancer Center (US)
Dana-Farber Cancer Institute (US)
Abramson Cancer Center (US)
University of Minnesota Medical Center (US)
Washington University in St. Louis (US)
University of Florida (US)
University of Wisconsin–Madison (US)
State University of New York (US)
Mount Sinai Hospital (US)
Oregon Health & Science University (US)
University of North Carolina at Chapel Hill (US)
BMT Group (United States) (US)
University of California, San Francisco (US)
The University of Texas MD Anderson Cancer Center (US)
University of Chicago (US)
University of Chicago Medical Center (US)
Medical College of Wisconsin (US)
ORCID: McCarthy, Philip L.
Owzar, Kouros
Hofmeister, Craig C.
Hassoun, Hani
Richardson, Paul G.
Giralt, Sergio
Stadtmauer, Edward A.
Weisdorf, Daniel J.
Vij, Ravi
Moreb, Jan S.
Callander, Natalie Scott
Gentile, Teresa
Isola, Luis
Maziarz, Richard T.
Landau, Heather
Martin, Thomas
Qazilbash, Muzaffar H.
McClune, Brian
Jiang, Chen
Bennett, Elizabeth
Kelly, Michael
Rosenbaum, Cara
Hari, Parameswaran
Pasquini, Marcelo C.
Horowitz, Mary M.
Devine, Steven M.
Anderson, Kenneth C.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2012-05-10
Volume: 366
Issue: 19
Pages: 1770-1781
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1114083
PMC: PMC3744390
OpenAlex: W2125721471
Semantic Scholar: b20a8f57aae32a45c1804976b107b4ba1609688f
Cited by: 1,147
References: 42
Citations by year: 2026: 28 · 2025: 30 · 2024: 40 · 2023: 40 · 2022: 51 · 2021: 74 · 2020: 81 · 2019: 70 · 2018: 82 · 2017: 104 · 2016: 107 · 2015: 100 · 2014: 113 · 2013: 144 · 2012: 81
FWCI: 93.26
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Digital Commons@Becker (Washington University School of Medicine) (submittedVersion)
Funders: National Heart, Lung, and Blood Institute (U10HL069334, U10HL069301, U10HL069348, U10HL109526, U01HL069294, U10HL069294, U10HL069330, U10HL069315, U10HL069290, U10HL069286, UG1HL069286, UG1HL069315)
National Cancer Institute (U10CA033601, P50CA100707, U10CA031946, U10CA021115, U24CA076518)
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, multiple myeloma, autologous stem cell transplantation, maintenance therapy, time to progression, overall survival, secondary malignancies, hematologic adverse events, drug toxicity
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, Maintenance Chemotherapy

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