• Completed

NCT01134484: Phase 3 - VELCADE-Thal-Dex (VTD) vs Thal-Dex (TD) Incorporated Into Double ASCT NDMM

Updated: Mar 28

GIMEMA-MMY-3006 Study

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.


Sponsor:

Michele Cavo


Collaborator:

Janssen-Cilag S.p.A.


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.

Lancet Haematol. 2020 Dec

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.

J Clin Oncol. 2013 Sep


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.

Blood. 2012 Jul

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.

Lancet. 2010 Dec


 

Drug: Velcade

Drug: Thalidomide

Drug: Dexamethasone

Procedure: Peripheral Blood Stem Cell (PBSC) collection

Procedure: First Autologous Transplantation

Procedure: Second Autologous Transplantation



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