Role of new drugs incorporated into consolidation and maintenance therapy in transplant-eligible multiple myeloma patients

Figures & data

Table 1. Studies of post-ASCT novel agent-based consolidation treatment.

Authors	Type of trial	Therapy	No. of patients	Response rate	PFS or TTP	OS
Bortezomib-based
Ladetto et al. [3]	Phase II	VTD	39	CR rate pre- vs post-VTD: 15 vs 49%	Median PFS 60 m	3-year OS: 89%
Cavo et al. [4]	Phase III	VTD vs TD	160/161	CR/nCR pre-consolidation 63 vs 55%; p = NS CR/nCR post-consolidation 73 vs 61%; p = 0.02	3-year PFS 60 vs 48%; p = 0.042	3-year OS: 90 vs 88%; p = NS
Leleu et al. [5]	Retrospective comparison	VTd vs no consolidation	121/96	CR post-consolidation 52 vs 30%; p = 0.001	Median TTP Not reached vs 25 m; p = 0.005	4-year OS: 84 vs 91%; p = NS
Mellqvist et al. [8]	Phase III	V vs no consolidation	187/183	> VGPR pre-consolidation 40 vs 39%; p = NS > VGPR post-consolidation 71 vs 57%; p = 0.009	Median PFS 27 m vs 20 m; p = 0.05	3-year OS: 80 vs 80%; p = NS
Lenalidomide-based
Roussel et al. [6]	Phase II	RVD consolidation	31	sCR/CR rate Pre- vs post-VRD: 42 vs 48%	NR	NR
Attal et al. [7]	Phase III	R consolidation + R maintenance vs R consolidation + placebo maintenance	307/307	CR rate pre- vs post-consolidation 58 vs 69%; p < 0.001	NR after consolidation	NR after consolidation

CR: Complete remission; m: Months; nCR: Near-complete remission; NR: Not reported; NS: Not significant; OS: Overall survival; PFS: Progression-free survival; R: Lenalidomide; RVD: Lenalidomide + bortezomib + dexamethasone; sCR: Stringent complete response; TD: Thalidomide + dexamethasone; TTP: Time to progression; V: Bortezomib; VGPR: Very good partial remission; VTD: Bortezomib + thalidomide + dexamethasone; VTd: Bortezomib + thalidomide + low-dose dexamethasone.

Table 2. Studies of post-ASCT bortezomib- and lenalidomide-based maintenance treatment.

Authors	Type of trial	Therapy	No. of patients	PFS or TTP or EFS	OS
Bortezomib-based
Sonneveld et al. [19]	Phase III	V vs T	414/413	Median PFS: 35 vs 28 m p = 0.002	Median follow-up 41 m; OS (Multivariate analysis): HR = 0.77; p = 0.049
Rosiñol et al. [20]	Phase III	VT vs T vs IFN-α	386*	2-year PFS: 78 vs 63 vs 49% p = 0.01	OS not significantly different
Lenalidomide-based
McCarthy et al. [14]	Phase III	R vs placebo	231/229	EFS or PFS or TTP: 46 vs 27 m; p < 0.001 3-year PFS: 66 vs 39% EFS: 43 vs 27 m; p < 0.001	OS at 34 m of median follow-up: 85 vs 77%; p = 0.028 3-year OS: 88 vs 80%; p = 0.03
Attal et al. [7]	Phase III	R vs placebo	307/307	PFS: 41 vs 23 m; p < 0.001 4-year PFS: 43 vs 22%; p < 0.001 EFS: 40 vs 23 m; p < 0.001	4-year OS 73 vs 75%; p = NS
Gay et al. [16]	Phase III	R vs no maintenance	198/204	Combining NIT and IT groups, median EFS: 37.5 vs 25.7 m; p = 0.0008	Combining NIT and IT groups, 4-year OS from start of maintenance: 80 vs 62%; p = 0.01

*Distribution for arm not reported.

EFS: Event-free survival; IFN-α: Interferon-α; IT: Intensive therapy; NIT: Non-intensive therapy; OS: Overall survival; PFS: Progression-free survival; R: Lenalidomide; T: Thalidomide; TTP: Time to progression; V: Bortezomib; VT: Bortezomib + thalidomide.

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