Aplidin - Dexamethasone in Relapsed/Refractory Myeloma
Aplidin - Dexamethasone in Relapsed/Refractory Myeloma
Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients
 with relapsed/refractory multiple myeloma.
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).
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
 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