Aplidin - Dexamethasone in Relapsed/Refractory Myeloma

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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