Table 4

Phase 3 studies and meta-analysis results in transplant-ineligible patients

StudyTreatment schema/durationNo. of patients in treatment armMedian follow-upBest responsePFSOS
MPT meta-analysis*56  MPT for 8 cycles, 12 cycles, or until relapse 1685 (total no. of patients included) Not available VGPR: 25% 20.3 mo 39.3 mo 
MPT (FIRST trial)74  MPT for 12 cycles 547 37 mo CR: 9.3% 21.2 mo 4-y OS: 51.4% 
CTD64  CTD for up to 9 cycles (6 cycles minimum) 426 44 mo CR: 13.1% 13 mo 33.2 mo 
VMP (VISTA trial)66  VMP for 9 cycles 344 60.1 mo CR: 30% 21.7 mo 56.4 mo 
MPR-R73  MPR for 9 cycles, followed by R until disease progression 152 30 mo CR: 9.9% 31 mo 4-y OS: 59% 
VMPT-VT67,69  VMPT for 9 cycles, followed by VT for 2 y or until progression or relapse 254 54 mo CR: 38% 35.3 mo 5-y OS: 61% 
VMP/VTP-VT68,70  VMP or VTP for 6 cycles, followed by VT for up to 3 y 91 46 mo CR: 46% 39 mo 5-y OS: 69% 
Rd continuous (FIRST trial)74  Rd until disease progression 535 37 mo CR: 15.1% 25.5 mo 4-y OS: 59.4% 
BP76  BP until maximum remission or disease progression 68 Not available CR: 32% TTF: 14 mo 32 mo 
StudyTreatment schema/durationNo. of patients in treatment armMedian follow-upBest responsePFSOS
MPT meta-analysis*56  MPT for 8 cycles, 12 cycles, or until relapse 1685 (total no. of patients included) Not available VGPR: 25% 20.3 mo 39.3 mo 
MPT (FIRST trial)74  MPT for 12 cycles 547 37 mo CR: 9.3% 21.2 mo 4-y OS: 51.4% 
CTD64  CTD for up to 9 cycles (6 cycles minimum) 426 44 mo CR: 13.1% 13 mo 33.2 mo 
VMP (VISTA trial)66  VMP for 9 cycles 344 60.1 mo CR: 30% 21.7 mo 56.4 mo 
MPR-R73  MPR for 9 cycles, followed by R until disease progression 152 30 mo CR: 9.9% 31 mo 4-y OS: 59% 
VMPT-VT67,69  VMPT for 9 cycles, followed by VT for 2 y or until progression or relapse 254 54 mo CR: 38% 35.3 mo 5-y OS: 61% 
VMP/VTP-VT68,70  VMP or VTP for 6 cycles, followed by VT for up to 3 y 91 46 mo CR: 46% 39 mo 5-y OS: 69% 
Rd continuous (FIRST trial)74  Rd until disease progression 535 37 mo CR: 15.1% 25.5 mo 4-y OS: 59.4% 
BP76  BP until maximum remission or disease progression 68 Not available CR: 32% TTF: 14 mo 32 mo 

MPR-R, melphalan-prednisone-lenalidomide-lenalidomide maintenance; TTF, time to treatment failure; VMPT-VT, bortezomib-melphalan-prednisone–thalidomide-bortezomib, thalidomide maintenance; VMP/VTP-VT, bortezomib-melphalan-prednisone/bortezomib-thalidomide-prednisone–bortezomib-thalidomide maintenance.

*

Meta-analysis based on individual data from 1685 patients included in 6 randomized trials.

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