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.
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).
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
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There is 1 Location for this study
Tuscaloosa Alabama, , United States
Los Angeles California, , United States
Jacksonville Florida, , United States
New York New York, , United States
Canton Ohio, , United States
Adelaide , , Australia
Canberra , , Australia
Geelong , , Australia
Parkville , , Australia
Perth , , Australia
South Brisbane , , Australia
Woodville , , Australia
Graz , , Austria
Innsbruck , , Austria
Salzburg , , Austria
Wien , , Austria
Wien , , Austria
Wien , , Austria
Brugge , , Belgium
Brussels , , Belgium
Brussels , , Belgium
Gent , , Belgium
Brno , , Czechia
Hradec Kralove , , Czechia
Praha , , Czechia
Lille , , France
Nantes , , France
Rouen , , France
Vandœuvre-lès-Nancy , , France
Düsseldorf , , Germany
Essen , , Germany
Frankfurt , , Germany
Frankfurt , , Germany
Freiburg , , Germany
Heidelberg , , Germany
Munchen , , Germany
Würzburg , , Germany
Athens , , Greece
Patras , , Greece
Thessaloniki , , Greece
Dublin , , Ireland
Bari , , Italy
Genova , , Italy
Reggio Emilia , , Italy
Rozzano , , Italy
San Giovanni Rotondo , , Italy
Torino , , Italy
Anyang , , Korea, Republic of
Daejeon , , Korea, Republic of
Hwasun , , Korea, Republic of
Incheon , , Korea, Republic of
Jeonju , , Korea, Republic of
Seongnam , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Rotterdam , , Netherlands
Rotterdam , , Netherlands
Christchurch , , New Zealand
Takapuna , , New Zealand
Opole , , Poland
Warszawa , , Poland
Braga , , Portugal
Porto , , Portugal
San Juan , , Puerto Rico
Barcelona , , Spain
Barcelona , , Spain
Barcelona , , Spain
Madrid , , Spain
Madrid , , Spain
Murcia , , Spain
Palma de Mallorca , , Spain
Salamanca , , Spain
San Sebastián , , Spain
Valencia , , Spain
Taipei , , Taiwan
Taipei , , Taiwan
Taipei , , Taiwan
Bournemouth , , United Kingdom
Bradford , , United Kingdom
London , , United Kingdom
Nottingham , , United Kingdom
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