Table 2.
Trial | Schedule |
---|---|
Cassiopeia (Intergroupe Francophone du Myélome/HOVON–NCT02541383) | Randomized trial of VTD versus VTD plus Dara (induction and consolidation) |
All patients receive ASCT | |
Second randomization to no maintenance versus maintenance Dara | |
MRD measurement (by NGF and NGS) will be done at baseline, post induction, post consolidation and then annually | |
PET-CT at baseline and post consolidati | |
FORTE (GIMEMA–NCT02203643) | Randomized trial of CRd versus CCyd (induction 4 cycles followed by ASCT followed by consolidation 4 cycles) versus CRd 8 cycles without ASCT |
Second randomization to maintenance Lenalidomide versus maintenance Lenalidomide/Carfilzomib | |
MRD measurement (by NGF and NGS) will be done at baseline, post induction (4 cycles), pre maintenance and then annually | |
PET-CT at baseline, post induction (4 cycles) and pre maintenance | |
GEM Menos 65 (PETHEMA – NCT 01916252 & NCT 02406144) | Randomized trial of Mel200 versus Bu-Mel as conditioning regimen to ASCT following 6 cycles of induction with VRD |
All patients receive consolidation with 2 cycles of VRD | |
Second randomization to Lenalidomide-dexamethasone maintenance versus Lenalidomide-dexamethasone-Ixazomib maintenance | |
MRD measurement by NGF will be done at baseline, post induction, post ASCT, post consolidation and then annually | |
Based on NGF results following 2 years of maintenance, decision to stop maintenance in case of sustained-MRD negativity, or prolong maintenance 3 additional years in case of NGF positivity |
VTD bortezomib, thalidomide, dexamethasone, ASCT autologous stem cell transplantation, Dara daratumumab, CRd carfilzomib-lenalidomide-dexamethasone, CCyd carfilzomib-cyclophosphamide-dexamethasone, VRD bortezomib-lenalidomide-dexamethasone, Mel 200 melphalan 200mg/m2, Bu-Mel busulfan-melphalan, Len-dex lenalidomide-dexamethasone, Len-dex-ixa lenalidomide-dexamethasone-ixazomib, Neg negative, Pos positive