A phase 2 study of ibrutinib in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma
Jazyk angličtina Země Anglie, Velká Británie Médium print-electronic
Typ dokumentu klinické zkoušky, fáze II, časopisecké články, multicentrická studie
Grantová podpora
Pharmacyclics LLC, an AbbVie Company
PubMed
31883396
PubMed Central
PMC7216833
DOI
10.1111/ejh.13377
Knihovny.cz E-zdroje
- Klíčová slova
- bortezomib, dexamethasone, ibrutinib, multiple myeloma,
- MeSH
- adenin aplikace a dávkování analogy a deriváty MeSH
- bortezomib aplikace a dávkování MeSH
- chemorezistence MeSH
- dexamethason aplikace a dávkování MeSH
- dospělí MeSH
- Kaplanův-Meierův odhad MeSH
- lidé středního věku MeSH
- lidé MeSH
- mnohočetný myelom diagnóza farmakoterapie mortalita MeSH
- opakovaná terapie MeSH
- piperidiny aplikace a dávkování MeSH
- prognóza MeSH
- protokoly protinádorové kombinované chemoterapie škodlivé účinky terapeutické užití MeSH
- recidiva MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- staging nádorů MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
- Názvy látek
- adenin MeSH
- bortezomib MeSH
- dexamethason MeSH
- ibrutinib MeSH Prohlížeč
- piperidiny MeSH
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.
Ankara University School of Medicine Ankara Turkey
Faculty of Medicine University of Ostrava Ostrava Czech Republic
General Hospital of Thessaloniki G Papanikolaou Thessaloniki Greece
Hospital Universitario Virgen del Rocio Sevilla Spain
IRCCS Casa Sollievo della Sofferenza Hospital San Giovanni Rotondo Italy
Pharmacyclics LLC an AbbVie Company Sunnyvale CA USA
Pharmacyclics Switzerland GmbH an AbbVie Company Schaffhausen Switzerland
University Hospital Brno Brno Czech Republic
University Hospital of Ostrava Ostrava Poruba Poruba Czech Republic
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