Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Phase I Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma|
- Recommended dose of plitidepsin in combinatio with bortezomib and dexamethasone [ Time Frame: After 28-day cycle ] [ Designated as safety issue: Yes ]
To determine the recommended dose (RD) of plitidepsin in combination with bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM).
To define the RD, patients will be evaluated for DLTs during the first 28-day cycle. The RD will be the highest DL at which fewer than two out of six (33%) of evaluable patients experience a DLT during the first 28-day cycle.
|Study Start Date:||June 2014|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Experimental: plitidepsin + bortezomib + dexamethasone
Plitidepsin will be administered as a 3-hour (h) intravenous (i.v.) infusion on Day (D) 1 and 15, every four weeks (q4wk).
Bortezomib will be administered as a subcutaneous (s.c.) injection on D1, 4, 8 and 11, q4wk, for a maximum of eight cycles.
Dexamethasone will be taken orally on D1, 8, 15 and 22, q4wk, for a maximum of eight cycles.
|Drug: Plitidepsin Drug: Bortezomib Drug: Dexamethasone|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02100657
|Institut Gustave Roussy||Recruiting|
|Contact: Dr. Vincent Ribrag|
|Hospital Universitario Germans Trias I Pujol||Recruiting|
|Contact: Albert Oriol|
|Contact: Rebeca Iglesias|
|Clínica Universitaria de Navarra||Recruiting|
|Contact: Felipe Prosper|
|Hospital Universitario Salamanca||Recruiting|
|Contact: María V. Mateos|
|Hospital Universitario Virgen del Rocío||Recruiting|
|Contact: José Pérez|
|Hospital Universitario La Fé||Recruiting|
|Contact: Javier De la Rubia|