Randomized Phase III Study of Lenalidomide Versus Placebo in RBC Transfusion-Dependent Patients With Lower-Risk Non-del(5q) Myelodysplastic Syndromes and Ineligible for or Refractory to Erythropoiesis-Stimulating Agents

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064165%3A_____%2F16%3A10337410" target="_blank" >RIV/00064165:_____/16:10337410 - isvavai.cz</a>

Alternative codes found

RIV/00216208:11110/16:10337410

Result on the web

<a href="http://dx.doi.org/10.1200/JCO.2015.66.0118" target="_blank" >http://dx.doi.org/10.1200/JCO.2015.66.0118</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1200/JCO.2015.66.0118" target="_blank" >10.1200/JCO.2015.66.0118</a>

Result language

angličtina

Original language name

Randomized Phase III Study of Lenalidomide Versus Placebo in RBC Transfusion-Dependent Patients With Lower-Risk Non-del(5q) Myelodysplastic Syndromes and Ineligible for or Refractory to Erythropoiesis-Stimulating Agents

Original language description

Purpose: This international phase III, randomized, placebo-controlled, double-blind study assessed the efficacy and safety of lenalidomide in RBC transfusion-dependent patients with International Prognostic Scoring System lower-risk non-del(5q) myelodysplastic syndromes ineligible for or refractory to erythropoiesis-stimulating agents. Patients and Methods: In total, 239 patients were randomly assigned (2:1) to treatment with lenalidomide (n = 160) or placebo (n = 79) once per day (on 28-day cycles). The primary end point was the rate of RBC transfusion independence (TI) >= 8 weeks. Secondary end points were RBC-TI >= 24 weeks, duration of RBC-TI, erythroid response, health-related quality of life (HRQoL), and safety.

Czech name

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Czech description

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Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

FD - Oncology and haematology

OECD FORD branch

—

Project

—

Continuities

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Publication year

2016

Confidentiality

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

Name of the periodical

Journal of Clinical Oncology

ISSN

0732-183X

e-ISSN

—

Volume of the periodical

34

Issue of the periodical within the volume

25

Country of publishing house

US - UNITED STATES

Number of pages

11

Pages from-to

2988-2996

UT code for WoS article

000382470100009

EID of the result in the Scopus database

2-s2.0-84983628285