A phase 2 study of ibrutinib in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma
Hájek, R (Faculty of Medicine. University of Ostrava)
Pour, L. (University Hospital Brno (República Txeca))
Ozcan, M. (Ankara University School of Medicine)
Martin Sánchez, J. (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
García Sanz, R. (Hospital Universitario de Salamanca)
Anagnostopoulos, Achilles (George Papanicolaou General Hospital (Tessalònica, Grècia))
Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras)
Cascavilla, N. (Istituto di Ricovero e Cura A Carattere Scientifico (IRCCS))
Terjung, A. (Pharmacyclics Switzerland GmbH. an AbbVie Company)
Lee, Y. (Pharmacyclics LLC. an AbbVie Company)
Briso, E. M. (Pharmacyclics Switzerland GmbH. an AbbVie Company)
Dobkowska, E. (Pharmacyclics Switzerland GmbH. an AbbVie Company)
Hauns, B. (Pharmacyclics Switzerland GmbH. an AbbVie Company)
Špička, I. (Charles University. Faculty of Medicine in Hradec Králové)
Universitat Autònoma de Barcelona

Date:	2020
Abstract:	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.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Bortezomib ; Dexamethasone ; Ibrutinib ; Multiple myeloma
Published in:	European Journal of Haematology, Vol. 104 Núm. 5 (january 2020) , p. 435-442, ISSN 1600-0609

DOI: 10.1111/ejh.13377
PMID: 31883396

8 p, 354.8 KB

The record appears in these collections:
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP) > Josep Carreras Leukaemia Research Institute
Articles > Research articles
Articles > Published articles