- Active, not recruiting
NCT01208766: Phase 3 - EMN02 - Compare VMP With HDM f/b VRD Consol & Lenalidomide Maint. NDMM (HO95)
Updated: Sep 25, 2022
The EMN02/HOVON95 trial
(EMN02/HO95): a multicentre, randomised, open-label, phase 3 study
Study to Compare VMP With HDM Followed by VRD Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma (HO95)
Study to Compare VMP With HDM Followed by VRD Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma (HO95)
Study objective: Comparison of Bortezomib, Melphalan, Prednisone (VMP) with High Dose Melphalan followed autologous stem cell transplantation (ASCT)
Comparison of Bortezomib, Lenalidomide, Dexamethasone(VRD) as consolidation versus no consolidation
Comparison of single versus tandem high dose Melphalan with ASCT
Patient population: Patients with symptomatic multiple myeloma,previously untreated, ISS stages 1-3, age 18-65 years inclusive
Study design: Prospective, multicenter, intergroup, randomized
Duration of treatment: Expected duration of induction, stem cell collection and intensification is 6 - 9 months. Consolidation with VRD will last 2 months Maintenance therapy with Lenalidomide will be given until relapse. All patients will be followed until 10 years after registration.
Drug: Bortezomib, Melphalan, Prednisone (VMP)
Drug: 1 or 2 cycle(s) HDM (High Dose Melphalan)
Drug: 2 cycles of Bortezomib, Lenalidomide, Dexamethasone (VRD)
Sponsor
Stichting Hemato-Oncologie voor Volwassenen Nederland
Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
DSMM (Deutsche Studiengruppe Multiples Myelom)
Central European Myeloma Study Group
ClinicalTrials.gov Identifier: NCT01208766
Official Title:A Randomized Phase III Study to Compare Bortezomib, Melphalan, Prednisone (VMP) With High Dose Melphalan Followed by Bortezomib, Lenalidomide, Dexamethasone (VRD) Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma
First Posted : September 24, 2010
Click here for details on ClinicalTrials.gov
J Clin Oncol 2021 Nov 10
Journal of Clinical Oncology > List of Issues > Volume 39, Issue 32 >
Vol. 39, No. 32, November 10, 2021
Consolidation and Maintenance in Newly Diagnosed Multiple Myeloma
Autologous haematopoietic stem-cell transplantation versus bortezomib-melphalan-prednisone, with or without bortezomib-lenalidomide-dexamethasone consolidation therapy, and lenalidomide maintenance for newly diagnosed multiple myeloma (EMN02/HO95): a multicentre, randomised, open-label, phase 3 study.
Lancet Haematol. 2020 Jun
Minimal residual disease by flow cytometry and allelic-specific oligonucleotide real-time quantitative polymerase chain reaction in patients with myeloma receiving lenalidomide maintenance: A pooled analysis.
Cancer. 2019 Mar
731. CLINICAL AUTOLOGOUS TRANSPLANTATION: RESULTS: NOVEL CONDITIONING & MAINTENANCE APPROACHES| DECEMBER 7, 2017
Double Autologous Stem Cell Transplantation Significantly Prolongs Progression-Free Survival and Overall Survival in Comparison with Single Autotransplantation in Newly Diagnosed Multiple Myeloma: An Analysis of Phase 3 EMN02/HO95 Study
Drug: Bortezomib, Melphalan, Prednisone (VMP)
Drug: 1 or 2 cycle(s) HDM (High Dose Melphalan)
Drug: 2 cycles of Bortezomib, Lenalidomide, Dexamethasone (VRD)
Locations
Australia
Austria
Belgium
Czechia
Denmark
Finland
Greece
Hungary
Italy
Netherlands
Norway
Portugal
Sweden
Switzerland
Turkey