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A Noninterventional, Observational, European Post-Authorization Safety Study of Patients With Relapsed/Refractory Multiple Myeloma Treated With Lenalidomide

The result's identifiers

  • Result code in IS VaVaI

    <a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61988987%3A17110%2F20%3AA21027J6" target="_blank" >RIV/61988987:17110/20:A21027J6 - isvavai.cz</a>

  • Alternative codes found

    RIV/00843989:_____/20:E0108601

  • Result on the web

    <a href="https://reader.elsevier.com/reader/sd/pii/S2152265020302342?token=59BB11D4A061DC392F6DA4B051B91F934DDD99027CEFEE7950B7C158FD23AF1AB987A6C25D0DF17497ED014E962DDBB5" target="_blank" >https://reader.elsevier.com/reader/sd/pii/S2152265020302342?token=59BB11D4A061DC392F6DA4B051B91F934DDD99027CEFEE7950B7C158FD23AF1AB987A6C25D0DF17497ED014E962DDBB5</a>

  • DOI - Digital Object Identifier

    <a href="http://dx.doi.org/10.1016/j.clml.2020.05.006" target="_blank" >10.1016/j.clml.2020.05.006</a>

Alternative languages

  • Result language

    angličtina

  • Original language name

    A Noninterventional, Observational, European Post-Authorization Safety Study of Patients With Relapsed/Refractory Multiple Myeloma Treated With Lenalidomide

  • Original language description

    Given the key role of lenalidomide in the treatment of relapsed/refractory multiple myeloma, it is important to evaluate the safety of lenalidomide in real-world populations of patients who may not qualify for clinical trial participation. This noninterventional, European post-authorization safety study confirms that the real-world safety profile of lenalidomide is similar to what has been reported in clinical trials. Introduction: Lenalidomide plus dexamethasone is effective and well tolerated in relapsed/refractory multiple myeloma (RRMM). In this observational, noninterventional European post-authorization safety study, the safety profile of lenalidomide plus dexamethasone was investigated and compared with that of other agents in the treatment of RRMM in a real-world setting. Patients and Methods: Patients had received >= 1 prior antimyeloma therapy; prior lenalidomide was excluded. Treatment was per investigator's routine practice. Adverse events were analyzed by incidence rates per 100 person-years to account for differences in observation length and treatment duration. Results: In total, 2150 patients initiated lenalidomide, and 1479 initiated any other antimyeloma therapy, predominately bortezomib (80.3%), which was primarily administered intravenously (74.3%). The incidence rate of neuropathy was lower with lenalidomide (10.5) than with bortezomib (78.9) or thalidomide (38.7). Lenalidomide also had a lower incidence rate of infections (68.7) versus bortezomib (95.9) and thalidomide (76.0). Conversely, the incidence rate of neutropenia was higher with lenalidomide (38.0) than with bortezomib (18.2) or thalidomide (25.7).

  • Czech name

  • Czech description

Classification

  • Type

    J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database

  • CEP classification

  • OECD FORD branch

    30205 - Hematology

Result continuities

  • Project

  • Continuities

    I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Others

  • Publication year

    2020

  • Confidentiality

    S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Data specific for result type

  • Name of the periodical

    Clinical Lymphoma Myeloma & Leukemia

  • ISSN

    2152-2650

  • e-ISSN

  • Volume of the periodical

    20

  • Issue of the periodical within the volume

    10

  • Country of publishing house

    US - UNITED STATES

  • Number of pages

    16

  • Pages from-to

    629-644

  • UT code for WoS article

    000585113900001

  • EID of the result in the Scopus database