RT Journal Article
T1 A phase 2 study of ibrutinib in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma.
A1 Hajek, Roman
A1 Pour, Ludek
A1 Ozcan, Muhit
A1 Martin Sánchez, Jesus
A1 García Sanz, Ramon
A1 Anagnostopoulos, Achilles
A1 Oriol, Albert
A1 Cascavilla, Nicola
A1 Terjung, Andreas
A1 Lee, Yihua
A1 Briso, Eva M
A1 Dobkowska, Edyta
A1 Hauns, Bernhard
A1 Špička, Ivan
K1 bortezomib
K1 dexamethasone
K1 ibrutinib
K1 multiple myeloma
AB 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. This was a phase 2, single-arm, open-label, multicentre study (NCT02902965). The primary endpoint was progression-free survival (PFS). 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. 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.
YR 2020
FD 2020-03-07
LK http://hdl.handle.net/10668/14899
UL http://hdl.handle.net/10668/14899
LA en
DS RISalud
RD Apr 10, 2025