NCT01134484: Phase 3 - VELCADE-Thal-Dex (VTD) vs Thal-Dex (TD) Incorporated Into Double ASCT NDMM
Updated: Mar 28, 2022
GIMEMA (Gruppo Italiano Malattie Ematologiche dell'Adulto Italian Myeloma Network).
VELCADE-Thalidomide-Dexamethasone (VTD) vs Thalidomide-Dexamethasone (TD) Incorporated Into Double Autotransplantation for Untreated Multiple Myeloma (MM)
Thalidomide-Dexamethasone (TD) is a standard induction therapy for Multiple Myeloma (MM). The present study is designed to compare TD with VELCADE-Thalidomide-Dexamethasone (VTD) as induction therapy in preparation for, and as consolidation after, melphalan-based double autologous stem cell transplantation for previously untreated patients aged ≤65 years with symptomatic MM. Primary study endpoint is the rate of complete response (CR) plus near-complete response (nCR) to induction treatment. Secondary endpoints include the rate of CR plus nCR to double transplantation and subsequent consolidation therapy, time to progression (TTP), progression-free survival (PFS),overall survival (OS) and toxicity profile of both VTD and TD.
Information provided by (Responsible Party):
Michele Cavo, IRCCS Azienda Ospedaliero-Universitaria di Bologna
ClinicalTrials.gov Identifier: NCT01134484
Official Title: A Phase 3, Prospective, Randomized Clinical Study of VELCADE-Thalidomide-Dexamethasone (VTD) Versus Thalidomide-Dexamethasone (TD) for Previously Untreated Multiple Myeloma (MM) Patients Who Are Candidates to Receive Double Autologous Transplantation
Bortezomib : National Cancer Institute
Bortezomib : MedlinePlus Drug Information
Dexamethasone : National Cancer Institute
Dexamethasone : MedlinePlus Drug Information
Thalidomide : National Cancer Institute
Thalidomide : MedlinePlus Drug Information
Bortezomib, thalidomide, and dexamethasone followed by double autologous haematopoietic stem-cell transplantation for newly diagnosed multiple myeloma (GIMEMA-MMY-3006): long-term follow-up analysis of a randomised phase 3, open-label study.
Bortezomib-based vers us nonbortezomib-based induction treatment before autologous stem-cell transplantation in patients with previously untreated multiple myeloma: a meta-analysis of phase III randomized, controlled trials.
Bortezomib-thal idomide-dexamethasone is superior to thalidomide-dexamethasone as consolidation therapy after autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myeloma.
Bortezomib with thalidomide plus dexamethasone compared with thalidomide plus dexamethasone as induction therapy before, and consolidation therapy after, double autologous stem-cell transplantation in newly diagnosed multiple myeloma: a randomised phase 3 study.
Procedure: Peripheral Blood Stem Cell (PBSC) collection
Procedure: First Autologous Transplantation
Procedure: Second Autologous Transplantation