NCT01102426

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: PharmaMar · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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).

Conditions

• Relapsed/Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Plitidepsin	plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
DRUG	Dexamethasone	4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.

Timeline

• Start date: 2010-06-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2010-04-13
• Last updated: 2020-11-10
• Results posted: 2020-10-22

Locations

82 sites across 19 countries: United States, Australia, Austria, Belgium, Czechia, France, Germany, Greece, Ireland, Italy, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom