Carfilzomib, bendamustine, and dexamethasone in patients with advanced multiple myeloma: The EMN09 phase 1/2 study of the European Myeloma Network.


Journal

Cancer
ISSN: 1097-0142
Titre abrégé: Cancer
Pays: United States
ID NLM: 0374236

Informations de publication

Date de publication:
15 09 2021
Historique:
revised: 22 03 2021
received: 05 11 2020
accepted: 16 04 2021
pubmed: 29 6 2021
medline: 9 3 2022
entrez: 28 6 2021
Statut: ppublish

Résumé

Combined therapy with carfilzomib, bendamustine, and dexamethasone was evaluated in this multicenter phase 1/2 trial conducted within the European Myeloma Network (EMN09 trial). Sixty-three patients with relapsed/refractory multiple myeloma who had received ≥2 lines of prior therapy were included. The phase 1 portion of the study determined the maximum tolerated dose of carfilzomib with bendamustine set at 70 mg/m On the basis of the phase 1 results, the recommended phase 2 dose for carfilzomib was 27 mg/m In heavily pretreated patients who have relapsed/refractory multiple myeloma, combined carfilzomib, bendamustine, and dexamethasone is an effective treatment option administered in the outpatient setting. Infection prophylaxis and attention to patients with cardiovascular predisposition are required.

Sections du résumé

BACKGROUND
Combined therapy with carfilzomib, bendamustine, and dexamethasone was evaluated in this multicenter phase 1/2 trial conducted within the European Myeloma Network (EMN09 trial).
METHODS
Sixty-three patients with relapsed/refractory multiple myeloma who had received ≥2 lines of prior therapy were included. The phase 1 portion of the study determined the maximum tolerated dose of carfilzomib with bendamustine set at 70 mg/m
RESULTS
On the basis of the phase 1 results, the recommended phase 2 dose for carfilzomib was 27 mg/m
CONCLUSIONS
In heavily pretreated patients who have relapsed/refractory multiple myeloma, combined carfilzomib, bendamustine, and dexamethasone is an effective treatment option administered in the outpatient setting. Infection prophylaxis and attention to patients with cardiovascular predisposition are required.

Identifiants

pubmed: 34181755
doi: 10.1002/cncr.33647
doi:

Substances chimiques

Oligopeptides 0
carfilzomib 72X6E3J5AR
Dexamethasone 7S5I7G3JQL
Bendamustine Hydrochloride 981Y8SX18M

Types de publication

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

Langues

eng

Sous-ensembles de citation

IM

Pagination

3413-3421

Subventions

Organisme : Onyx/Amgen
Organisme : Mundipharma Germany
Organisme : HOVON Foundation
Organisme : FoNeSa ONLUS

Informations de copyright

© 2021 The Authors. Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society.

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Auteurs

Francesca Gay (F)

Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero Universitaria Città della Salute e della Scienza, Torino, Italy.

Andreas Günther (A)

Division of Stem Cell Transplantation and Immunotherapy, University of Kiel, Kiel, Germany.

Massimo Offidani (M)

Hematology Clinic, AOU Ospedali Riuniti di Ancona, Ancona, Italy.

Monika Engelhardt (M)

Department for Hematology and Oncology, University of Freiburg, Faculty of Freiburg, Freiburg, Germany.

Marco Salvini (M)

Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero Universitaria Città della Salute e della Scienza, Torino, Italy.

Vittorio Montefusco (V)

Hematology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.

Francesca Patriarca (F)

Hematology and Transplant Unit, University of Udine, Udine, Italy.

Sara Aquino (S)

Ematologia e Centro Trapianti, IRCCS Ospedale Policlinico San Martino, Genova, Italy.

Wolfram Pönisch (W)

Department of Hematology, University of Leipzig, Leipzig, Germany.

Stefano Spada (S)

Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero Universitaria Città della Salute e della Scienza, Torino, Italy.

Natalie Schub (N)

Division of Stem Cell Transplantation and Immunotherapy, University of Kiel, Kiel, Germany.

Silvia Gentili (S)

UODS Ematologia AV3, Civitanova Marche, Italy.

Ralph Wäsch (R)

Department for Hematology and Oncology, University of Freiburg, Faculty of Freiburg, Freiburg, Germany.

Paolo Corradini (P)

Hematology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.

Christian Straka (C)

Department of Hematology and Oncology, Munich Clinic Schwabing, Munich, Germany.

Antonio Palumbo (A)

Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero Universitaria Città della Salute e della Scienza, Torino, Italy.

Hermann Einsele (H)

Department of Medicine II, University Hospital of Würzburg, Würzburg, Germany.

Mario Boccadoro (M)

Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero Universitaria Città della Salute e della Scienza, Torino, Italy.

Pieter Sonneveld (P)

Department of Hematology, Erasmus University Medical Center Cancer Institute, Rotterdam, The Netherlands.

Martin Gramatzki (M)

Division of Stem Cell Transplantation and Immunotherapy, University of Kiel, Kiel, Germany.

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