Aplidin - Dexamethasone in Relapsed/Refractory Myeloma

Randomized, Multicenter, Open-label, Phase III Study of Plitidepsin in Combination With Dexamethasone vs. Dexamethasone Alone in Patients With Relapsed/Refractory Multiple 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