Aplidin - Dexamethasone in Relapsed/Refractory Myeloma

PHASE3CompletedINTERVENTIONAL
Enrollment

255

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

November 30, 2017

Study Completion Date

November 30, 2017

Conditions
Relapsed/Refractory Multiple Myeloma
Interventions
DRUG

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.

DRUG

Dexamethasone

4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.

Trial Locations (82)

Unknown

1107, Tuscaloosa

1103, Los Angeles

1105, Jacksonville

1102, New York

1104, Canton

108, Adelaide

102, Canberra

101, Geelong

105, Parkville

106, Perth

104, South Brisbane

109, Woodville

202, Graz

204, Innsbruck

203, Salzburg

201, Vienna

205, Vienna

208, Vienna

304, Bruges

301, Brussels

303, Brussels

302, Ghent

502, Brno

503, Hradec Králové

501, Prague

601, Lille

602, Nantes

606, Rouen

604, Vandœuvre-lès-Nancy

709, Düsseldorf

705, Essen

706, Frankfurt

707, Frankfurt

708, Freiburg im Breisgau

703, Heidelberg

702, München

704, Würzburg

1301, Athens

1303, Pátrai

1302, Thessaloniki

1401, Dublin

806, Bari

801, Genova

805, Reggio Emilia

803, Rozzano

804, San Giovanni Rotondo

802, Torino

901, Rotterdam

902, Rotterdam

1601, Christchurch

1602, Takapuna

1704, Opole

1703, Warsaw

1802, Braga

1801, Porto

2001, San Juan

1502, Anyang

1501, Daejeon

1507, Hwasun

1506, Incheon

1505, Jeonju

1508, Seongnam

1503, Seoul

1504, Seoul

1509, Seoul

1201, Barcelona

1203, Barcelona

1209, Barcelona

1207, Madrid

1210, Madrid

1206, Murcia

1204, Palma de Mallorca

1208, Salamanca

1202, San Sebastián

1205, Valencia

1901, Taipei

1902, Taipei

1903, Taipei

1003, Bournemouth

1004, Bradford

1001, London

1005, Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PharmaMar

INDUSTRY