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
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30205 - Hematology
Result continuities
Project
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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
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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
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