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@article{1775023,
author = {Hajek, R and Pour, Luděk and Ozcan, M and Sanchez, JM and Sanz, RG and Anagnostopoulos, A and Oriol, A and Cascavilla, N and Terjung, A and Lee, YH and Briso, EM and Dobkowska, E and Hauns, B and Spicka, I},
article_location = {Hoboken},
article_number = {5},
doi = {http://dx.doi.org/10.1111/ejh.13377},
keywords = {bortezomib; dexamethasone; ibrutinib; multiple myeloma},
language = {eng},
issn = {0902-4441},
journal = {European Journal of Haematology},
note = {Bez afiliace k MU.},
title = {A phase 2 study of ibrutinib in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma},
volume = {104},
year = {2020}
}
TY - JOUR
ID - 1775023
AU - Hajek, R - Pour, Luděk - Ozcan, M - Sanchez, JM - Sanz, RG - Anagnostopoulos, A - Oriol, A - Cascavilla, N - Terjung, A - Lee, YH - Briso, EM - Dobkowska, E - Hauns, B - Spicka, I
PY - 2020
TI - A phase 2 study of ibrutinib in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma
JF - European Journal of Haematology
VL - 104
IS - 5
SP - 435-442
EP - 435-442
PB - Wiley-Blackwell
SN - 09024441
N1 - Bez afiliace k MU.
KW - bortezomib
KW - dexamethasone
KW - ibrutinib
KW - multiple myeloma
N2 - 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 treatment. 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 haemorrhage. After an observed increased incidence of serious (42%) and fatal (11%) infections, 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 enrolment indicated that the targeted PFS could not be reached with additional patient enrolment, and the study was terminated.
ER -
HAJEK, R, Luděk POUR, M OZCAN, JM SANCHEZ, RG SANZ, A ANAGNOSTOPOULOS, A ORIOL, N CASCAVILLA, A TERJUNG, YH LEE, EM BRISO, E DOBKOWSKA, B HAUNS and I SPICKA. A phase 2 study of ibrutinib in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma. \textit{European Journal of Haematology}. Hoboken: Wiley-Blackwell, 2020, vol.~104, No~5, p.~435-442. ISSN~0902-4441. Available from: https://dx.doi.org/10.1111/ejh.13377.
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