CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
Plitidepsindrug
Likely dose
Plitidepsin as a 3-hour infusion every 2 weeksAI-extracted
Key inclusion· 7
  • ✓Age ≥18 years
  • ✓ECOG performance status ≤2
  • ✓Life expectancy ≥3 months
  • ✓Relapsed or refractory multiple myeloma (MM relapses following response to standard/high-dose chemotherapy, or refractory disease with failure to achieve CR, PR, or SD to most recent chemotherapy)
Key exclusion· 13
  • ✕Prior therapy with Aplidin (plitidepsin)
  • ✕History of unstable angina, myocardial infarction, valvular heart disease, or congestive heart failure
  • ✕Previous mediastinal radiotherapy
  • ✕Uncontrolled arterial hypertension despite optimal medical therapy

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

Search/NCT00229203
NCT00229203Phase 2Completed
CompareCT.gov

"Phase II Multicenter, Open-Label, Clinical and Pharmacokinetic Study of Aplidin® As A 3-Hour Infusion Every 2 Weeks Alone or in Combination With Dexamethasone, in Pre-Treated Patients With Relapsing or Refractory Multiple Myeloma."

PharmaMar·interventional·Posted Sep 29, 2005·Updated Dec 24, 2009

In Brief

A Phase 2 clinical trial evaluating Plitidepsin for Multiple Myeloma. Completed, enrolled 51 participants across 1 site.

Detailed Summary

This is a phase II study to determine the efficacy following treatment with Aplidin® 5 mg/m2, given as a 3 hours intravenous infusion every 2 weeks, in patients with relapsed or refractory multiple myeloma (MM).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 29, 2005
Enrollment StartFeb 1, 2005
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 20.8 years ago

Interventions

Plitidepsindrug

3-hour infusion every 2 weeks alone or in combination with dexamethasone