Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61988987%3A17110%2F21%3AA2202CSZ" target="_blank" >RIV/61988987:17110/21:A2202CSZ - isvavai.cz</a>

Alternative codes found

RIV/00216208:11110/21:10429358 RIV/65269705:_____/21:00074475 RIV/00064165:_____/21:10429358

Result on the web

<a href="https://www.webofscience.com/wos/woscc/full-record/WOS:000663124100024" target="_blank" >https://www.webofscience.com/wos/woscc/full-record/WOS:000663124100024</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/S0140-6736(21)00592-4" target="_blank" >10.1016/S0140-6736(21)00592-4</a>

Result language

angličtina

Original language name

Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial

Original language description

Background Isatuximab is an anti-CD38 monoclonal antibody approved in combination with pomalidomide-dexamethasone and carfilzomib-dexamethasone for relapsed or refractory multiple myeloma. This phase 3, openlabel study compared the efficacy of isatuximab plus carfilzomib-dexamethasone versus carfilzomib-dexamethasone in patients with relapsed multiple rnyeloma. Methods This was a prospective, randomised, open-label, parallel-group, phase 3 study done at 69 study centres in 16 countries across North America, South America, Europe, and the Asia-Pacific region. Patients with relapsed or refractory multiple rnyelorna aged at least 18 years who had received one to three previous lines of therapy and had measurable serum or urine M-protein were eligible. Patients were randomly assigned (3:2) to isatuximab plus carfilzomib-dexamethasone (isatuximab group) or carfilzomib-dexamethasone (control group). Patients in the isatuximab group received isatuximab 10 mg/kg intravenously weekly for the first 4 weeks, then every 2 weeks. Both groups received time approved schedule of intravenous carfilzomib and oral or intravenous dexamethasone. Treatment continued until progression or unacceptable toxicity. The primary endpoint was progression-free survival and was assessed in the intention-to-treat population according to assigned treatment. Safety was assessed in all patients who received at least one dose according to treatment received. The study is registered at ClinicalTrials.gov, NCT03275285. Findings Between Nov 15,2017, and March 21,2019,302 patients with a median of two previous lines of therapy were enrolled. 179 were randomly assigned to the isatuximab group and 123 to the control group.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30218 - General and internal medicine

Project

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Continuities

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Publication year

2021

Confidentiality

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

Name of the periodical

Lancet

ISSN

0140-6736

e-ISSN

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Volume of the periodical

397

Issue of the periodical within the volume

10292

Country of publishing house

GB - UNITED KINGDOM

Number of pages

11

Pages from-to

2361-2371

UT code for WoS article

000663124100024

EID of the result in the Scopus database

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