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
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30205 - Hematology
Result continuities
Project
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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
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