Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
255 participants
INTERVENTIONAL
2010-06-30
2017-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Plitidepsin+Dexamethasone
plitidepsin + dexamethasone combination
Plitidepsin
plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
Dexamethasone
4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
Dexamethasone
dexamethasone single agent
Dexamethasone
4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
Interventions
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Plitidepsin
plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
Dexamethasone
4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
* Life expectancy ≥ 3 months.
* Patients previously diagnosed with multiple myeloma
* Patients must have relapsed or relapsed and refractory multiple myeloma (MM) after at least three but not more than six prior therapeutic regimens for MM, including induction therapy and stem cell transplant in candidate patients, which will be considered as only one regimen.
* Patients must have received previous bortezomib-containing and lenalidomide-containing regimens (or thalidomide where lenalidomide is not available)
* Women must have a negative serum pregnancy test
* Voluntarily signed and dated written informed consent
Exclusion Criteria
* Women who are pregnant or breast feeding.
* Concomitant medications that include corticosteroids, chemotherapy, or other therapy that is or may be active against MM
* Known hypersensitivity to any involved study drug or any of its formulation components
18 Years
ALL
No
Sponsors
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PharmaMar
INDUSTRY
Responsible Party
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Principal Investigators
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Óscar F. Ballester, M.D.
Role: PRINCIPAL_INVESTIGATOR
Edwards Comprehensive Cancer Center, Marshall University (Huntington)
Rubén Niesvizky, M.D.
Role: PRINCIPAL_INVESTIGATOR
NY Presbyterian Hosp. - Cornell University - NY
Locations
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1107
Tuscaloosa, Alabama, United States
1103
Los Angeles, California, United States
1105
Jacksonville, Florida, United States
1102
New York, New York, United States
1104
Canton, Ohio, United States
108
Adelaide, , Australia
102
Canberra, , Australia
101
Geelong, , Australia
105
Parkville, , Australia
106
Perth, , Australia
104
South Brisbane, , Australia
109
Woodville, , Australia
202
Graz, , Austria
204
Innsbruck, , Austria
203
Salzburg, , Austria
201
Vienna, , Austria
205
Vienna, , Austria
208
Vienna, , Austria
304
Bruges, , Belgium
301
Brussels, , Belgium
303
Brussels, , Belgium
302
Ghent, , Belgium
502
Brno, , Czechia
503
Hradec Králové, , Czechia
501
Prague, , Czechia
601
Lille, , France
602
Nantes, , France
606
Rouen, , France
604
Vandœuvre-lès-Nancy, , France
709
Düsseldorf, , Germany
705
Essen, , Germany
706
Frankfurt, , Germany
707
Frankfurt, , Germany
708
Freiburg im Breisgau, , Germany
703
Heidelberg, , Germany
702
München, , Germany
704
Würzburg, , Germany
1301
Athens, , Greece
1303
Pátrai, , Greece
1302
Thessaloniki, , Greece
1401
Dublin, , Ireland
806
Bari, , Italy
801
Genova, , Italy
805
Reggio Emilia, , Italy
803
Rozzano, , Italy
804
San Giovanni Rotondo, , Italy
802
Torino, , Italy
901
Rotterdam, , Netherlands
902
Rotterdam, , Netherlands
1601
Christchurch, , New Zealand
1602
Takapuna, , New Zealand
1704
Opole, , Poland
1703
Warsaw, , Poland
1802
Braga, , Portugal
1801
Porto, , Portugal
2001
San Juan, , Puerto Rico
1502
Anyang, , South Korea
1501
Daejeon, , South Korea
1507
Hwasun, , South Korea
1506
Incheon, , South Korea
1505
Jeonju, , South Korea
1508
Seongnam, , South Korea
1503
Seoul, , South Korea
1504
Seoul, , South Korea
1509
Seoul, , South Korea
1201
Barcelona, , Spain
1203
Barcelona, , Spain
1209
Barcelona, , Spain
1207
Madrid, , Spain
1210
Madrid, , Spain
1206
Murcia, , Spain
1204
Palma de Mallorca, , Spain
1208
Salamanca, , Spain
1202
San Sebastián, , Spain
1205
Valencia, , Spain
1901
Taipei, , Taiwan
1902
Taipei, , Taiwan
1903
Taipei, , Taiwan
1003
Bournemouth, , United Kingdom
1004
Bradford, , United Kingdom
1001
London, , United Kingdom
1005
Nottingham, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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APL-C-001-09
Identifier Type: -
Identifier Source: org_study_id