⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

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

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: