Phase I study of plitidepsin in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma.


Journal

Cancer medicine
ISSN: 2045-7634
Titre abrégé: Cancer Med
Pays: United States
ID NLM: 101595310

Informations de publication

Date de publication:
02 2023
Historique:
revised: 23 06 2022
received: 30 03 2022
accepted: 02 08 2022
pubmed: 22 9 2022
medline: 3 3 2023
entrez: 21 9 2022
Statut: ppublish

Résumé

Previous studies showed antitumor activity for plitidepsin plus dexamethasone (DXM) in relapsed/refractory multiple myeloma (r/r MM), and in vitro synergism with bortezomib (BTZ) or DXM against MM cells. This phase I trial evaluated plitidepsin (3-h intravenous infusion Day 1 and 15), BTZ (subcutaneous bolus Day 1, 4, 8, and 11), and DXM (orally Day 1, 8, 15, and 22), every 4 weeks in 36 r/r MM patients. Twenty-two patients were treated using a standard dose escalation design (10 at the recommended dose [RD] cohort), and 14 additional patients were treated to expand the RD cohort. No dose-limiting toxicities (DLTs) occurred during dose escalation. The highest dose level evaluated (plitidepsin 5.0 mg/m

Identifiants

pubmed: 36127823
doi: 10.1002/cam4.5250
pmc: PMC9972151
doi:

Substances chimiques

Bortezomib 69G8BD63PP
plitidepsin Y76ID234HW
Dexamethasone 7S5I7G3JQL
Depsipeptides 0

Types de publication

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

Langues

eng

Sous-ensembles de citation

IM

Pagination

3999-4009

Informations de copyright

© 2022 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

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Auteurs

María Victoria Mateos (MV)

Hospital Universitario de Salamanca, Salamanca, Spain.

Felipe Prosper (F)

Clínica Universidad de Navarra, Pamplona, Spain.
Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Instituto de Salud Carlos III, Madrid, Spain.

Jesús Martin Sánchez (J)

Hospital Universitario Virgen del Rocio, Sevilla, Spain.

Enrique M Ocio (EM)

Hospital Universitario de Salamanca, Salamanca, Spain.
Hospital Universitario Marqués de Valdecilla (IDIVAL), Universidad de Cantabria, Santander, Spain.

Albert Oriol (A)

Institut Català d'Oncologia, Hospital Germans Trias i Pujol, Badalona, Spain.

Cristina Motlló (C)

Institut Català d'Oncologia, Hospital Germans Trias i Pujol, Badalona, Spain.

Jean-Marie Michot (JM)

Institut Gustave Roussy, Villejuif, France.

Isidro Jarque (I)

Hospital Universitario La Fe, Valencia, Spain.

Rebeca Iglesias (R)

M.D. Anderson Cancer Center, Madrid, Spain.

María Solé (M)

Hospital Universitario Virgen del Rocio, Sevilla, Spain.

Sara Martínez (S)

PharmaMar, Madrid, Spain.

Carmen Kahatt (C)

PharmaMar, Madrid, Spain.

Salvador Fudio (S)

PharmaMar, Madrid, Spain.

Gema Corral (G)

PharmaMar, Madrid, Spain.

Ali Zeaiter (A)

PharmaMar, Madrid, Spain.

Lola Montilla (L)

PharmaMar, Madrid, Spain.

Vincent Ribrag (V)

Institut Gustave Roussy, Villejuif, France.

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Classifications MeSH