CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 646 enrolled
Drug / intervention
Bortezomib (VELCADE) +2 moredrug
Likely dose
Bortezomib 1.3 mg/m² IV on days 1, 4, 8, 11 of each 21-day cycle (up to 8 cycles); Doxorubicin HCL liposome (DOXIL/CAELYX) IV on day 4 of each 21-day cycle (up to 8 cycles)AI-extracted
Key inclusion· 3
  • ✓At least 1 prior therapy with either response followed by progressive disease or primary refractory disease
  • ✓Prior doxorubicin cumulative dose ≤240 mg/m² (or equivalent anthracycline dose)
  • ✓Normal cardiac function with LVEF within institutional normal limits
Key exclusion· 7
  • ✕Prior treatment with VELCADE (bortezomib)
  • ✕Progressive disease while receiving anthracycline-containing regimen
  • ✕No change in disease status (primary refractory to first therapy) — conflicting inclusion criterion
  • ✕Non-secretory disease

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

Search/NCT00103506
NCT00103506Phase 3Completed
CompareCT.gov

A Randomized Controlled Study of DOXIL/CAELYX (Doxorubicin HCL Liposome Injection) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma

Janssen Research & Development, LLC·interventional·Posted Feb 10, 2005·Updated Oct 19, 2015

In Brief

A Phase 3 clinical trial evaluating Bortezomib (VELCADE) and Doxorubicin hydrochloride (DOXIL/CAELYX) for Multiple Myeloma. Completed, enrolled 646 participants across 108 sites in 17 countries.

Detailed Summary

The purpose of this study is to evaluate time to progression, overall survival, response rate and safety for the two open-label treatment groups; DOXIL/CAELYX in combination with VELCADE vs. VELCADE monotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesArgentina, Australia, Austria, Belgium, Canada, Czechia, France, Israel, Netherlands, Poland, Portugal, Russia, Singapore, South Africa, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 10, 2005
Enrollment StartDec 1, 2004
Primary CompletionMay 1, 2014
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9.4 yearsPosted 21.4 years ago

Interventions

Bortezomib (VELCADE)drug

1.3 mg/m\^2 by rapid (bolus) i.v. administration given on Days 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.

Bortezomib (VELCADE)drug

1.3 mg/m\^2 by rapid (bolus) i.v. administration given on Days 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles..

Doxorubicin hydrochloride (DOXIL/CAELYX)drug

mg/m\^2 by i.v. infusion will be given on Day 4 of every 21-day cycle after the administration of bortezomib (VELCADE) for up to 8 cycles.