Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT02100657|
Recruitment Status : Completed
First Posted : April 1, 2014
Last Update Posted : July 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Plitidepsin Drug: Bortezomib Drug: Dexamethasone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||June 2018|
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
- Recommended dose of plitidepsin in combination with bortezomib and dexamethasone [ Time Frame: After 28-day cycle ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100657
|Institut Gustave Roussy|
|Villejuif, France, 94805|
|Hospital Universitario Germans Trias I Pujol|
|Badalona, Barcelona, Spain, 08916|
|Clínica Universidad de Navarra|
|Pamplona, Navarra, Spain, 31008|
|MD Anderson Cancer Center Madrid|
|Madrid, Spain, 28033|
|Hospital Universitario Salamanca|
|Salamanca, Spain, 37007|
|Hospital Universitario Virgen del Rocío|
|Sevilla, Spain, 41013|
|Hospital Universitari i Politècnic la Fe|
|Valencia, Spain, 46026|