CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 502 enrolled
Drug / intervention
Bortezomib +4 moredrug
Likely dose
Not stated in 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/NCT00507416
NCT00507416Phase 3Completed

Randomized Phase 3b Study of Three Treatment Regimens in Subjects With Previously Untreated Multiple Myeloma Who Are Not Considered Candidates for High-Dose Chemotherapy and Autologous Stem Cell Transplantation: VELCADE, Thalidomide, and Dexamethasone Versus VELCADE and Dexamethasone Versus VELCADE, Melphalan, and Prednisone

Millennium Pharmaceuticals, Inc.·interventional·Posted Jul 26, 2007·Updated May 1, 2014

In Brief

A Phase 3 clinical trial evaluating Bortezomib, Dexamethasone, and 3 other interventions for Multiple Myeloma. Completed, enrolled 502 participants across 235 sites in 2 countries.

Detailed Summary

This is a randomized, open label, multicenter clinical trial to compare the efficacy and safety of Velcade (bortezomib) and dexamethasone versus Velcade, thalidomide, and dexamethasone versus Velcade, melphalan, and prednisone in patients with previously untreated multiple myeloma not considered candidates for high-dose chemotherapy and autologous stem cell transplantation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 26, 2007
Enrollment StartJun 1, 2007
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 18.9 years ago

Interventions

Bortezomibdrug

Bortezomib bolus intravenous (IV) injection

Dexamethasonedrug

Dexamethasone for oral administration

Melphalandrug

Melphalan for oral administration

Prednisonedrug

Prednisone for oral administration

Thalidomidedrug

Thalidomide for oral administration