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

The result's identifiers

  • Result code in 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>

  • Alternative codes found

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

  • Result on the web

    <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>

Alternative languages

  • Result language

    angličtina

  • Original language name

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

  • Original language description

    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.

  • Czech name

  • Czech description

Classification

  • Type

    J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database

  • CEP classification

  • OECD FORD branch

    30205 - Hematology

Result continuities

  • Project

  • 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

    EUROPEAN JOURNAL OF HAEMATOLOGY

  • ISSN

    0902-4441

  • e-ISSN

    1600-0609

  • Volume of the periodical

    104

  • Issue of the periodical within the volume

    5

  • Country of publishing house

    US - UNITED STATES

  • Number of pages

    8

  • Pages from-to

    435-442

  • UT code for WoS article

    000526168200009

  • EID of the result in the Scopus database