. 2017 Dec 8;2017(1):212–222. doi: 10.1182/asheducation-2017.1.212

Table 2.

Phase 2 and phase 3 trials evaluating the role of consolidation therapy after ASCT

References	Age (median), y; no. of patients	Induction therapy	Consolidation therapy	Improvement in depth of response	EFS or PFS^*	OS^*	Comments
Ladetto et al⁹	59	VAD 4 cycles, single ASCT	VTD	CR: 15%-49%	MRD^neg: 68 mo	OS at 8 y	Clear benefit of consolidation therapy and long-term MRD monitoring in MM patients
Ferrero et al¹⁰	N = 39	VAD 4 cycles, single ASCT	VTD	MRD^neg: 3%-19%	MRD^pos: 23 mo (P < .001)	MRD^neg: 72%; MRD^pos: 42% (P < .041)
Cavo et al¹⁴	57.4; N = 160	VTD; double ASCT	VTD × 2	CR: 60.6%; CR/nCR 73.1%	PFS at 3 y: 60%; PFS: median not reached	No difference in OS recorded	No difference in outcome in patients with and without high-risk cytogenetics
Cavo et al¹⁴	56.8; N = 161	TD; double ASCT	TD × 2	CR: 46.6% (P = .012); CR/nCR: 60.9% (P = .020)	PFS at 3 y: 48% (P = .042); PFS: 32 mo	No difference in OS recorded
Mellqvist et al¹¹	59.1; N = 187	Cyclophosphamide/dexamethasone or high-dose dexamethasone in the majority of patients	20 Doses of bortezomib given during 21 wk	VGPR: 71%; CR/nCR: 45%	27 mo	OS at 3 y 80%, no difference between both groups
Mellqvist et al¹¹	Control; 58.7; N = 183	Single ASCT	None	VGPR: 57% (P < .01); CR/nCR 35 (P = .055)	20 mo (P = .05)	OS at 3 y 80%, no difference between both groups
Stadtmauer et al¹⁷	57; N = 254	Different regimes	VRD × 4	n.a.	PFS at 38 mo; 57%	No difference in OS recorded	Largest randomized US transplant trial in MM, showed comparable PFS and OS
Stadtmauer et al¹⁷	N = 257	Single ASCT	None	n.a.	PFS at 38 mo; 52%	No difference in OS recorded
Jackson et al¹⁸	N = 292	CTD/CTDa	CVD × 4	From MR/PR to VGPR/CR: 41%	PFS: 30 mo	n.a.	Greater PFS benefit in TE patients
Jackson et al¹⁸	N = 289	CRD/CRDa	CVD × 4	n.a.	PFS: 24 mo	n.a.	Greater PFS benefit in TE patients
Sonneveld et al⁴¹	N = 459	VCD × 4 plus either VMP or single or double ASCT	RVD × 2		PFS from R2: 65%	No difference	Benefit seen in patients with revised ISS 3 but not in patients with high-risk cytogenetics
Sonneveld et al⁴¹	N = 444	VCD × 4 plus either VMP or single or double ASCT	RVD × 2		PFS from R2: 60%	No difference
Einsele et al¹²	59	VCD, VD, VAD, AD, idarubicin/dexamethasone	Four 35-d cycles of bortezomib	Greater than or equal to VGPR: 62%	PFS: 33.6 mo	Similar in both groups	Greater benefit in patients with greater than or equal to VGPR, similar effect in standard- and high-risk patients; 15% of patients discontinued TX because of AE
Einsele et al¹²	N = 371	Single ASCT	Four 35-d cycles of bortezomib	VGPR: 48% (P = .003)	PFS: 27.8 mo (P = .0058)	(P = .75)
Sezer et al¹³	58.0; N = 51	Bortezomib based in majority of patients	Four 35-d cycles of bortezomib	sCR/CR: 22%, greater than or equal to VGPR: 80%	44.9 mo	40.1 mo	No statistically significant differences
Sezer et al¹³	Control: 57.0; N = 53	Single or double ASCT	None	sCR/CR: 11%; greater than or equal to VGPR: 68%	21.8 mo	36.6 mo (P = .098)	No statistically significant differences

AD, doxorubicin-dexamethasone; AE, adverse event; CRD, cyclophosphamide-Revlimid-dexamethasone; CRDa, same as CRD, but 6 cycles; CTD, cyclophosphamide-thalidomide-dexamethasone; CTDa, same as CTD, but 6 cycles; EFS, event-free survival; HR, hazard ratio; ISS, International Staging System; MM, multiple myeloma; MR, minor response; n.a., not available; nCR, near complete remission; R2, second relapse; RVD, Revlimid-Velcade-dexamethasone; TX, treatment; VAD, vincristine-doxorubicin-dexamethasone; VCD, Velcade-cyclophosphamide-dexamethasone; VD, Velcade-dexamethasone; VGPR, very good partial response.

Median unless otherwise stated.