A phase 2 study of ibrutinib in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61988987%3A17110%2F20%3AA21025A1" target="_blank" >RIV/61988987:17110/20:A21025A1 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11110/20:10411601 RIV/65269705:_____/20:00072713 RIV/00843989:_____/20:E0108436 RIV/00064165:_____/20:10411601

Výsledek na webu

<a href="https://onlinelibrary.wiley.com/doi/epdf/10.1111/ejh.13377" target="_blank" >https://onlinelibrary.wiley.com/doi/epdf/10.1111/ejh.13377</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1111/ejh.13377" target="_blank" >10.1111/ejh.13377</a>

Jazyk výsledku

angličtina

Název v původním jazyce

A phase 2 study of ibrutinib in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma

Popis výsledku v původním jazyce

Objective: We evaluated ibrutinib, a once-daily inhibitor of Bruton's tyrosine kinase,combined with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma who had received 1-3 prior therapies.Methods: This was a phase 2, single-arm, open-label, multicentre study (NCT02902965). The primary endpoint was progression-free survival (PFS).Results: Seventy-six patients were enrolled; 74 received ≥1 dose of study treat-ment. After median follow-up of 19.6 months, median PFS was 8.5 months (95% CI: 6.2-10.8); median overall survival was not reached. Overall response rate was 57% (95% CI: 45-68), and median duration of response was 9.5 months (95% CI: 6.9-10.6). Grade 3/4 AEs occurred in 73% of patients and fatal AEs occurred in 15% of patients. Incidence of major haemorrhage was 5%; one patient died from cerebral haemor-rhage. After an observed increased incidence of serious (42%) and fatal (11%) in-fections, enrolment was suspended to implement risk-minimisation measures. The safety profile was otherwise consistent with known safety profiles of the individual drugs.Conclusion: Ibrutinib combined with bortezomib and dexamethasone elicited clinical responses. However, efficacy assessments conducted at potential restart of enrol-ment indicated that the targeted PFS could not be reached with additional patient enrolment, and the study was terminated.

Název v anglickém jazyce

A phase 2 study of ibrutinib in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma

Popis výsledku anglicky

Objective: We evaluated ibrutinib, a once-daily inhibitor of Bruton's tyrosine kinase,combined with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma who had received 1-3 prior therapies.Methods: This was a phase 2, single-arm, open-label, multicentre study (NCT02902965). The primary endpoint was progression-free survival (PFS).Results: Seventy-six patients were enrolled; 74 received ≥1 dose of study treat-ment. After median follow-up of 19.6 months, median PFS was 8.5 months (95% CI: 6.2-10.8); median overall survival was not reached. Overall response rate was 57% (95% CI: 45-68), and median duration of response was 9.5 months (95% CI: 6.9-10.6). Grade 3/4 AEs occurred in 73% of patients and fatal AEs occurred in 15% of patients. Incidence of major haemorrhage was 5%; one patient died from cerebral haemor-rhage. After an observed increased incidence of serious (42%) and fatal (11%) in-fections, enrolment was suspended to implement risk-minimisation measures. The safety profile was otherwise consistent with known safety profiles of the individual drugs.Conclusion: Ibrutinib combined with bortezomib and dexamethasone elicited clinical responses. However, efficacy assessments conducted at potential restart of enrol-ment indicated that the targeted PFS could not be reached with additional patient enrolment, and the study was terminated.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

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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

EUROPEAN JOURNAL OF HAEMATOLOGY

ISSN

0902-4441

e-ISSN

1600-0609

Svazek periodika

104

Číslo periodika v rámci svazku

5

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

8

Strana od-do

435-442

Kód UT WoS článku

000526168200009

EID výsledku v databázi Scopus

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