Multiple Myeloma Clinical Trial

Aplidin – Dexamethasone in Relapsed/Refractory Myeloma

Summary

Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma.

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Full Description

Phase III Study in Patients with Relapsed/Refractory Multiple Myeloma to compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone measured by progression-free survival (PFS) and to evaluate tumor response, duration of response (DR), overall survival (OS) and to rule out any effect of plitidepsin on the duration of the QT/QTc interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years.
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 treatment-for-multiple-myeloma-induction-therapy/" >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:

Concomitant diseases/conditions
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

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

255

Study ID:

NCT01102426

Recruitment Status:

Completed

Sponsor:

PharmaMar

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There is 1 Location for this study

See Locations Near You

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
Wien , , Austria
205
Wien , , Austria
208
Wien , , Austria
304
Brugge , , Belgium
301
Brussels , , Belgium
303
Brussels , , Belgium
302
Gent , , Belgium
502
Brno , , Czechia
503
Hradec Kralove , , Czechia
501
Praha , , 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 , , Germany
703
Heidelberg , , Germany
702
Munchen , , Germany
704
Würzburg , , Germany
1301
Athens , , Greece
1303
Patras , , 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
1502
Anyang , , Korea, Republic of
1501
Daejeon , , Korea, Republic of
1507
Hwasun , , Korea, Republic of
1506
Incheon , , Korea, Republic of
1505
Jeonju , , Korea, Republic of
1508
Seongnam , , Korea, Republic of
1503
Seoul , , Korea, Republic of
1504
Seoul , , Korea, Republic of
1509
Seoul , , Korea, Republic of
901
Rotterdam , , Netherlands
902
Rotterdam , , Netherlands
1601
Christchurch , , New Zealand
1602
Takapuna , , New Zealand
1704
Opole , , Poland
1703
Warszawa , , Poland
1802
Braga , , Portugal
1801
Porto , , Portugal
2001
San Juan , , Puerto Rico
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

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

255

Study ID:

NCT01102426

Recruitment Status:

Completed

Sponsor:


PharmaMar

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