Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma

Phase I Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma

Study of Plitidepsin (Aplidin®) to determine the recommended dose (RD) of plitidepsin in Combination with Bortezomib and Dexamethasone in Patients with Relapsed and/or Refractory Multiple Myeloma.

Phase I Multicenter, Open-label, Dose-escalating Clinical and Pharmacokinetic Trial of Plitidepsin (Aplidin®) to determine the recommended dose (RD) of plitidepsin in combination with bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM), to determine the efficacy of the combination plitidepsin/bortezomib/dexamethasone, to evaluate the safety and tolerability of the combination in patients with relapsing and/or refractory MM and to study the pharmacokinetics (PK) and pharmacodynamics (PDy) of plitidepsin in combination with bortezomib and dexamethasone.

Inclusion Criteria:

• Age ≥ 18 years.
• Prior autologous transplantation (HSCT) patients are allowed.
• Patients must have received at least one previous treatment line of induction, chemotherapy, chemotherapy and transplantation or previous treatment with bortezomib or another proteasome drug

Exclusion Criteria:

• Previous treatment with plitidepsin.
• Active or metastatic primary malignancy other than MM.
• Serious concomitant systemic disorders
• History of hypersensitivity reactions to bortezomib, polyoxyl 35 castor oil or mannitol
• Neuropathy
• Pregnant and/or lactating women
• HIV infection
• Active hepatitis B or C virus infection.
• Treatment with any Investigational Medicinal Product (IMP) in the 30 days before inclusion in the study
• Plasma cell leukemia at the time of study entry
• Contraindication for the use of steroids