NCT03896737: Phase 2: EMN 18 - Dara-VCd VS VTd Then Maintenance With Ixazomib (IXA) or IXA-Dara

EMN 18

Daratumumab-bortezomib-dexamethasone (Dara-VCd) vs Bortezomib-Thalidomide-Dexamethasone (VTd), Then Maintenance With Ixazomib (IXA) or IXA-Dara

This protocol is a phase II multicenter, randomized, open label study designed to assess the efficacy and safety of daratumumab combined with bortezomib, cyclophosphamide and dexamethasone (Dara-VCd) versus the association of bortezomib, thalidomide and dexamethasone (VTd) as pre transplant induction and post transplant consolidation, followed by maintenance with ixazomib alone or in combination with daratumumab, in newly diagnosed multiple myeloma (MM) patients eligible for autologous stem cell transplantation.

Sponsor:

European Myeloma Network

Collaborator:

EMN Research Italy

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ClinicalTrials.gov Identifier: NCT03896737

Official Title: A Multicenter, Open Label, Randomized Phase II Study Comparing Daratumumab Combined With Bortezomib-Cyclophosphamide-dexamethasone (Dara-VCd) Versus the Association of Bortezomib-Thalidomide-dexamethasone (VTd) as Pre Transplant Induction and Post Transplant Consolidation, Both Followed by a Maintenance Phase With Ixazomib Alone or in Combination With Daratumumab, in Newly Diagnosed Multiple Myeloma (MM) Young Patients Eligible for Autologous Stem Cell Transplantation

First Posted : April 1, 2019

Click here for details on ClinicalTrials.gov

EMN18 - European Myeloma Network (myeloma-europe.org)

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Drug: Daratumumab plus Velcade Cyclophosphamide Dexamethasone

Drug: Velcade Thalidomide Dexamethasone

MRD Testing

Adaptive Biotechnologies, Seattle

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Locations

Europe

Czechia

Greece

Ireland

Italy