NCT01208766: Phase 3 - EMN02 - Compare VMP With HDM f/b VRD Consol & Lenalidomide Maint. NDMM (HO95)

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)

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Sponsor

Stichting Hemato-Oncologie voor Volwassenen Nederland

Collaborators

European Myeloma Network

Gruppo Italiano Malattie EMatologiche dell'Adulto

DSMM (Deutsche Studiengruppe Multiples Myelom)

NMSG (Nordic Myeloma Study Group)

Central European Myeloma Study Group

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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

EMN02 - European Myeloma Network (myeloma-europe.org)

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Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information

Bortezomib : National Cancer Institute

Bortezomib : MedlinePlus Drug Information

Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information

Melphalan: National Cancer Institute

Melphalan: MedlinePlus Drug Information

Prednisone: National Cancer Institute

Prednisone: MedlinePlus Drug Information

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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

https://ascopubs.org/doi/pdf/10.1200/JCO.21.01045

https://pubmed.ncbi.nlm.nih.gov/34520219/

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

https://pubmed.ncbi.nlm.nih.gov/32359506/

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

https://pubmed.ncbi.nlm.nih.gov/30561775/

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

Click here for details

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Drug: Bortezomib, Melphalan, Prednisone (VMP)

Drug: 1 or 2 cycle(s) HDM (High Dose Melphalan)

Drug: 2 cycles of Bortezomib, Lenalidomide, Dexamethasone (VRD)

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Locations

Australia

Austria

Belgium

Czechia

Denmark

Finland

Greece

Hungary

Italy

Netherlands

Norway

Portugal

Sweden

Switzerland

Turkey