Trial of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Multiple Myeloma Patients Double Refractory to Bortezomib and Lenalidomide

PHASE2TerminatedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

May 8, 2017

Primary Completion Date

July 30, 2018

Study Completion Date

July 30, 2018

Conditions
Multiple Myeloma
Interventions
DRUG

plitidepsin

Patients received plitidepsin as a 3-hour i.v. infusion at a dose of 5 mg/m2 on Days 1 and 15 every Four Weeks.

DRUG

Bortezomib

BTZ as a 3-5 second bolus s.c. injection at a dose of 1.3 mg/m2 on Days 1, 4, 8 and 11 every four weeks

DRUG

Dexamethasone

DXM orally at a dose of 40 mg/day on Days 1, 8, 15 and 22 every four weeks

Trial Locations (13)

15706

Complexo Hospitalario Universitario de Santiago, Santiago de Compostela

17007

Institut Català d´Oncologia Girona, Girona

30008

Hospital General Universitario J.M. Morales Meseguer, Murcia

31008

Clinica Universidad de Navarra, Pamplona

37007

Hospital Universitario de Salamanca, Salamanca

41013

Complejo Hospitalario Regional Virgen Del Rocio, Seville

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola

59037

CHRU de Lille - Hôpital Claude Huriez, Lille

94800

Institut Gustave Roussy, Villejuif

95123

Policlinico Vittorio Emanuele Hospital, Catania

00126

Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino

08916

Hospital Universitario Germans Trias i Pujol, Badalona

08908

Institut Català d´Oncologia L´Hospitalet, L'Hospitalet de Llobregat

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PharmaMar

INDUSTRY