Phase 1 study of selinexor plus carfilzomib and dexamethasone for the treatment of relapsed/refractory multiple myeloma.


Journal

British journal of haematology
ISSN: 1365-2141
Titre abrégé: Br J Haematol
Pays: England
ID NLM: 0372544

Informations de publication

Date de publication:
08 2019
Historique:
received: 26 11 2018
accepted: 22 03 2019
pubmed: 28 5 2019
medline: 4 6 2020
entrez: 25 5 2019
Statut: ppublish

Résumé

Selinexor, an oral Selective Inhibitor of Nuclear Export, targets Exportin 1 (XPO1, also termed CRM1). Non-clinical studies support combining selinexor with proteasome inhibitors (PIs) and corticosteroids to overcome resistance in relapsed/refractory multiple myeloma (RRMM). We conducted a phase I dose-escalation trial of twice-weekly selinexor in combination with carfilzomib and dexamethasone (SKd) to determine maximum tolerated dose in patients with RRMM (N = 21), with an expansion cohort to assess activity in carfilzomib-refractory disease and identify a recommended phase II dose (RP2D). During dose escalation, there was one dose-limiting toxicity (cardiac failure). The RP2D of twice-weekly SKd was selinexor 60 mg, carfilzomib 20/27 mg/m

Identifiants

pubmed: 31124580
doi: 10.1111/bjh.15969
pmc: PMC6772147
doi:

Substances chimiques

Hydrazines 0
Oligopeptides 0
Triazoles 0
selinexor 31TZ62FO8F
carfilzomib 72X6E3J5AR
Dexamethasone 7S5I7G3JQL

Banques de données

ClinicalTrials.gov
['NCT02199665']

Types de publication

Clinical Trial, Phase I Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

549-560

Informations de copyright

© 2019 British Society for Haematology and John Wiley & Sons Ltd.

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Auteurs

Andrzej J Jakubowiak (AJ)

University of Chicago Medical Center, Chicago, IL, USA.

Jagoda K Jasielec (JK)

University of Chicago Medical Center, Chicago, IL, USA.

Cara A Rosenbaum (CA)

Weill Cornell Medical College, New York, NY, USA.

Craig E Cole (CE)

Department of Medicine, Division of Hematology/Oncology, University of Michigan School of Medicine, Ann Arbor, MI, USA.

Ajai Chari (A)

Tisch Cancer Institute/Multiple Myeloma Program, Mount Sinai School of Medicine, New York, NY, USA.

Joseph Mikhael (J)

Mayo Clinic, Phoenix, AZ, and International Myeloma Foundation, Los Angeles, CA, USA.

Jennifer Nam (J)

University of Chicago Medical Center, Chicago, IL, USA.

Amanda McIver (A)

University of Chicago Medical Center, Chicago, IL, USA.

Erica Severson (E)

University of Chicago Medical Center, Chicago, IL, USA.

Leonor A Stephens (LA)

University of Chicago Medical Center, Chicago, IL, USA.

Kathryn Tinari (K)

University of Chicago Medical Center, Chicago, IL, USA.

Shaun Rosebeck (S)

University of Chicago Medical Center, Chicago, IL, USA.

Todd M Zimmerman (TM)

University of Chicago Medical Center, Chicago, IL, USA.

Tyler Hycner (T)

University of Chicago Medical Center, Chicago, IL, USA.

Agata Turowski (A)

University of Chicago Medical Center, Chicago, IL, USA.

Theodore Karrison (T)

University of Chicago Medical Center, Chicago, IL, USA.

Jeffrey A Zonder (JA)

Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA.

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