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

Kód výsledku v 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>

Nalezeny alternativní kódy

RIV/00843989:_____/20:E0108601

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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).

Název v anglickém jazyce

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

Popis výsledku anglicky

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).

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30205 - Hematology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2020

Kód důvěrnosti údajů

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

Název periodika

Clinical Lymphoma Myeloma & Leukemia

ISSN

2152-2650

e-ISSN

—

Svazek periodika

20

Číslo periodika v rámci svazku

10

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

16

Strana od-do

629-644

Kód UT WoS článku

000585113900001

EID výsledku v databázi Scopus

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