CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 255 enrolled
Drug / intervention
Plitidepsin +1 moredrug
Likely dose
Plitidepsin 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01102426
NCT01102426Phase 3Completed
CompareCT.gov

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

PharmaMar·interventional·Posted Apr 13, 2010·Updated Nov 10, 2020

In Brief

A Phase 3 clinical trial evaluating Plitidepsin and Dexamethasone for Relapsed/Refractory Multiple Myeloma. Completed, enrolled 255 participants across 82 sites in 19 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsed/Refractory Multiple Myeloma
CountriesAustralia, Austria, Belgium, Czechia, France, Germany, Greece, Ireland, Italy, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 13, 2010
Enrollment StartJun 1, 2010
Primary CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 16.2 years ago

Interventions

Plitidepsindrug

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.

Dexamethasonedrug

4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.