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Brief Title: Trial of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Multiple Myeloma Patients Double Refractory to Bortezomib and Lenalidomide
Official Title: Phase II Trial of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Multiple Myeloma Patients Double Refractory to Bortezomib and Lenalidomide
Study ID: NCT03117361
Brief Summary: This is a multi-center, open-label, single arm, non-comparative phase II trial, designed to evaluate the efficacy of plitidepsin in combination with bortezomib and dexamethasone in patients with Multiple Myeloma (MM) double refractory to bortezomib and lenalidomide.
Detailed Description: This is a multi-center, open-label, single arm, non-comparative phase II trial, designed to evaluate the efficacy of plitidepsin in combination with bortezomib and dexamethasone in patients with MM double refractory to bortezomib and lenalidomide.The primary endpoint will be overall response rate (ORR), including stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and partial response (PR). Approximately 64 evaluable patients will be needed for the evaluation of the primary endpoint, ORR. An early futility analysis will be performed with the efficacy data collected from the first 20 evaluable patients. The futility analysis will commence once patient number 20 has completed two full treatment cycles. Patient recruitment will not be halted during the conduct of this futility analysis.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
CHRU de Lille - Hôpital Claude Huriez, Lille, , France
Institut Gustave Roussy, Villejuif, , France
Policlinico Vittorio Emanuele Hospital, Catania, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino, , Italy
Hospital Universitario Germans Trias i Pujol, Badalona, Barcelona, Spain
Clinica Universidad de Navarra, Pamplona, Navarra, Spain
Institut Català d´Oncologia Girona, Girona, , Spain
Institut Català d´Oncologia L´Hospitalet, Hospitalet de Llobregat, , Spain
Hospital General Universitario J.M. Morales Meseguer, Murcia, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Complexo Hospitalario Universitario de Santiago, Santiago De Compostela, , Spain
Complejo Hospitalario Regional Virgen Del Rocio, Sevilla, , Spain