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Daratumumab-bortezomib-dexamethasone (Dara-VCd) vs Bortezomib-Thalidomide-Dexamethasone (VTd), Then Maintenance With Ixazomib (IXA) or IXA-Dara
Condition: Multiple Myeloma · Sponsor: European Myeloma Network B.V.
About this study
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. Patients enrolled in the Dara-VCd arm will receive: 4 cycles of daratumumab-bortezomib-cyclophosphamide-dexamethasone induction, followed by transplantation and 2 cycles of daratumumab-bortezomib-cyclophosphamide-dexamethasone consolidation. The choice of cyclophosphamide in combination with bortezomib and dexamethasone is suggested by the better safety profile of cyclophosphamide, in comparison with thalidomide and the efficacy of the alkylator agent, when combined with bortezomib. Once-weekly bortezomib seems to be equally effective and better tolerated than the standard twice weekly schedule. The outcomes and response rate did not appear to be affected by the bortezomib dosing schedule. Patients enrolled in the VTd arm will receive: 4 cycles of bortezomib-thalidomide-dexamethasone induction, followed by autologous transplantation and 2 cycles of bortezomib-thalidomide dexamethasone as consolidation. The VTd drug association is the current standard first line ind…
This description comes directly from the study's public registry record.
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Locations (24)
| Hradec Kralove-University Hospital Hradec Kralove | Hradec Králové, Czechia | — |
| University Hospital Olomouc | Olomouc, Czechia | — |
| University Hospital Ostrava | Ostrava, Czechia | — |
| University Hospital Ostrava | Ostrava, Czechia | — |
| University Hospital Plzen | Pilsen, Czechia | — |
| General University Hospital (VFN)-Internal Medicine, Hematology Clinic | Prague, Czechia | — |
| General Hospital of Athens "Alexandra" | Athens, Greece | — |
| General Hospital of Athens 'Evangelismos | Athens, Greece | — |
| University General Hospital of Patras | Pátrai, Greece | — |
| A.O.U. Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi di Ancona | Ancona, Italy | — |
| A.O. Papa Giovanni XXIII | Bergamo, Italy | — |
| Policlinico S. Orsola | Bologna, Italy | — |
+ 12 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03896737