CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 256 enrolled
Drug / intervention
Thalidomide +4 moredrug
Likely dose
Thalidomide 100 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/NCT01539083
NCT01539083Phase 3Completed

An Open-label, Randomised Trial of Bortezomib Consolidation (With Thalidomide and Prednisolone) Vs Thalidomide and Prednisolone Alone in Previously Untreated Subjects With Multiple Myeloma After Receiving Bortezomib, Cyclophosphamide, Dexamethasone (VCD) Induction and Autologous Stem Cell Transplant

Janssen Scientific Affairs, LLC·interventional·Posted Feb 27, 2012·Updated Feb 4, 2025

In Brief

A Phase 3 clinical trial evaluating Thalidomide, Bortezomib, and 3 other interventions for Multiple Myeloma. Completed, enrolled 256 participants across 23 sites in 3 countries.

Detailed Summary

The purpose of this study is to determine if bortezomib when added to consolidation treatment with thalidomide and prednisolone leads to an improved response in patients with multiple myeloma who have undergone autologous stem cell transplant and initial treatment with bortezomib, cyclophosphamide, and dexamethasone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, China, South Korea
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 27, 2012
Enrollment StartJan 13, 2012
Primary CompletionDec 30, 2015
Study CompletionJan 9, 2018
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 14.3 years ago

Interventions

Thalidomidedrug

Thalidomide 100 mg tablet, orally.

Bortezomibdrug

Bortezomib 1.3 milligram per square meter (mg/m\^2) solution for injection subcutaneously (SC).

Cyclophosphamidedrug

Cyclophosphamide 300 mg/m\^2 orally.

Dexamethasonedrug

Dexamethasone 20 mg orally.

Prednisolonedrug

Prednisolone 50 mg orally.