Table 1. Recent randomized studies... | American Society of Hematology

Table 1.

Recent randomized studies comparing ASCT to conventional chemotherapy

Study	Induction	ASCT/Consolidation	Maintenance*	PFS	OS	Salvage ASCT at relapse†
GIMEMA RV-209⁵	Rd ×4	Tandem ASCT vs MPR ×6	Each arm randomized to Len vs no maintenance	Median PFS: 43.0 mo (MEL200) vs 22.4 mo (MPR) (P < .001)	4-y OS: 81.6% (MEL200) vs 65.3% (MPR) (P = .02)	6% (MEL200) vs 70% (MPR)
RV-MM-EMN-441⁶	Rd ×4	1 or 2 ASCT vs CRD ×6	Each arm randomized to Len alone vs Len plus prednisone until progression	Median PFS: 43.3 mo (MEL200) vs 28.6 mo (CRD) (P < .001)	4-y OS: 86% (MEL200) vs 73% (CRD) (P = .004)	21% (MEL200) vs 43% (CRD)
IFM/DFCI 2009⁷	RVD ×3	ASCT followed by RVD ×2 vs RVD ×5	Len for both arms until progression (US) or for 1 y (French)	3-y PFS‡: 61% (ASCT) vs 48% (RVD)	3-y OS‡: 88% in both arms	Not reported
EMN02/HO95⁸	VCD ×3-4	First randomization: ASCT (1 or 2) vs VMP	Len for both arms until progression	3-y PFS: 66% (ASCT) vs 57.5% (VMP)	No differences but values not yet reported	Not reported
EMN02/HO95⁸	VCD ×3-4	Second randomization: VRD ×2 vs none	Len for both arms until progression	3-y PFS: 66% (ASCT) vs 57.5% (VMP)	No differences but values not yet reported	Not reported

Study	Induction	ASCT/Consolidation	Maintenance*	PFS	OS	Salvage ASCT at relapse†
GIMEMA RV-209⁵	Rd ×4	Tandem ASCT vs MPR ×6	Each arm randomized to Len vs no maintenance	Median PFS: 43.0 mo (MEL200) vs 22.4 mo (MPR) (P < .001)	4-y OS: 81.6% (MEL200) vs 65.3% (MPR) (P = .02)	6% (MEL200) vs 70% (MPR)
RV-MM-EMN-441⁶	Rd ×4	1 or 2 ASCT vs CRD ×6	Each arm randomized to Len alone vs Len plus prednisone until progression	Median PFS: 43.3 mo (MEL200) vs 28.6 mo (CRD) (P < .001)	4-y OS: 86% (MEL200) vs 73% (CRD) (P = .004)	21% (MEL200) vs 43% (CRD)
IFM/DFCI 2009⁷	RVD ×3	ASCT followed by RVD ×2 vs RVD ×5	Len for both arms until progression (US) or for 1 y (French)	3-y PFS‡: 61% (ASCT) vs 48% (RVD)	3-y OS‡: 88% in both arms	Not reported
EMN02/HO95⁸	VCD ×3-4	First randomization: ASCT (1 or 2) vs VMP	Len for both arms until progression	3-y PFS: 66% (ASCT) vs 57.5% (VMP)	No differences but values not yet reported	Not reported
EMN02/HO95⁸	VCD ×3-4	Second randomization: VRD ×2 vs none	Len for both arms until progression	3-y PFS: 66% (ASCT) vs 57.5% (VMP)	No differences but values not yet reported	Not reported

Len, lenalidomide.

Len was dosed 21 of 28 days in all studies except the IFM/DFCI 2009 study where it was dosed daily.

Percentage of patients who relapsed while in the maintenance phase who received salvage ASCT.

Results are for the IFM study; US study still accruing.