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

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PharmaMar
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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