Aplidin - Dexamethasone in Relapsed/Refractory 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