Table 2. Triplet regimens in randomized... | American Society of Hematology

Table 2.

Triplet regimens in randomized trials of newly diagnosed multiple myeloma^a

Trial	Regimen	Duration of treatment	N	ORR	> = VGPR	> = CR	Median PFS (months)	Median OS (months)	Median follow-up (months)
IFM 2009 NCT01191060¹⁴ NDMM, age <65 y	VRd + ASCT + R maintenance	3 cycles +2 cycles post ASCT + R maintenance × 1 y	350	98%	88%	59%	47.3	NR, 60.2% at 8 y	93
IFM 2009 NCT01191060¹⁴ NDMM, age <65 y	VRd + R maintenance	8 cycles + R maintenance × 1 y	350	97%	77%	48%	35.0	NR, 62.2% at 8 years	93
DETERMINATION¹⁵ NCT01208662 NDMM, age <65 y	VRd + ASCT + R maintenance	3 cycles +2 cycles post ASCT + R maintenance until progression	365	98%	83%	47%	67.5	NR, 80.7% at 5 y	76
DETERMINATION¹⁵ NCT01208662 NDMM, age <65 y	VRd + R maintenance	8 cycles + R maintenance until progression	357	95%	80%	42%	46.2	NR, 79.2% at 5 y	76
GIMEMA-MMY-3006 NCT01134484³¹ NDMM, age <65 y	VTd + double ASCT + VTd consolidation + dex maintenance	3 cycles +2 cycles consolidation post double ASCT + dexamethasone maintenance until progression/ tolerated	236	96%	89%	58%	60	NR	124.1
GIMEMA-MMY-3006 NCT01134484³¹ NDMM, age <65 y	Td + double ASCT + Td consolidation + dex maintenance		238	89%	74%	41%	41	110	124.1
GEM05menos65 NCT00461747³² NDMM, age <65 y	VTd + IFNα2b/T/ VT maintenance	24-week induction + ASCT + maintenance × 3 years	130	85% after induction	60% after induction	35% after induction	56.1	60% at 8 y	70.6
	Td + IFNα2b/T/ VT maintenance		127	62% after induction	29% after induction	14% after induction	29.2
	VBMCP/VBAD/ bortezomib + IFNα2b/T/VT maintenance		129	75% after induction	36% after induction	21% after induction	39.9
NCT00910897³³ NDMM, age <65 y	VTd + ASCT	4 cycles + ASCT	100	89% after ASCT	74% after ASCT	29% after ASCT	26		32
NCT00910897³³ NDMM, age <65 y	Vd + ASCT	4 cycles + ASCT	99	86% after ASCT	58% after ASCT	31% after ASCT	30	-	32
IFM2013-04 NCT01564537³⁴ NDMM, age <65 y	VCd	4 cycles	169	83.4% after induction	56.2% after induction	8.9% after induction	-	-	-
IFM2013-04 NCT01564537³⁴ NDMM, age <65 y	VTd	4 cycles	169	92.3% after induction	66.3% after induction	13% after induction	-		-
S0777 NCT00644228¹⁷ NDMM	VRd + Rd maintenance	8 cycles + Rd maintenance until progression/ tolerated	225	90.2%	74.9%	24.2%	41	NR	84
S0777 NCT00644228¹⁷ NDMM	Rd + Rd maintenance	6 cycles + Rd maintenance until progression/ tolerated	235	78.8%	53.2%	12.1%	29	69	84
UPFRONT NCT00507416³⁵ NDMM	Vd + V maintenance	8 cycles induction +35 weeks maintenance	168	73%	37%	3%	14.7	49.8	42.7
	VTd + V maintenance		167	80%	51%	4%	15.4	51.5
	VMP + V maintenance		167	70%	41%	4%	17.3	53.1
ENDURANCE NCT01863550²⁵ NDMM	VRd + R maintenance	12 cycles + maintenance × 2 years vs until progression/ tolerated	542	84% after induction	65% after induction	15% after induction	34.4 mo	NR, 84% at 3 y	26
ENDURANCE NCT01863550²⁵ NDMM	KRd + R maintenance	9 cycles + maintenance × 2 years vs until progression/ tolerated	545	87% after induction	74% after induction	18% after induction	34.6 mo	NR, 86% at 3 y	26
TOURMALINE-MM2 NCT01850524³⁶ NDMM	IRd	18 cycles + maintenance until progression/ tolerated	351	82.1%	63%	25.6%	35.3	NR	~58
	Placebo-Rd		351	82.1%	63%	25.6%	35.3	NR
	Placebo-Rd		354	79.7%	47.7%	14.1%	21.8	NR
MAIA NCT02252172³⁷ NDMM	DRd	Treatment continued until progression/ tolerated	368	92.9%	81%	51%	NR	NR	56.2
	Rd
	Rd		369	81.6%	57%	30%	34.4	NR

Trial	Regimen	Duration of treatment	N	ORR	> = VGPR	> = CR	Median PFS (months)	Median OS (months)	Median follow-up (months)
IFM 2009 NCT01191060¹⁴ NDMM, age <65 y	VRd + ASCT + R maintenance	3 cycles +2 cycles post ASCT + R maintenance × 1 y	350	98%	88%	59%	47.3	NR, 60.2% at 8 y	93
IFM 2009 NCT01191060¹⁴ NDMM, age <65 y	VRd + R maintenance	8 cycles + R maintenance × 1 y	350	97%	77%	48%	35.0	NR, 62.2% at 8 years	93
DETERMINATION¹⁵ NCT01208662 NDMM, age <65 y	VRd + ASCT + R maintenance	3 cycles +2 cycles post ASCT + R maintenance until progression	365	98%	83%	47%	67.5	NR, 80.7% at 5 y	76
DETERMINATION¹⁵ NCT01208662 NDMM, age <65 y	VRd + R maintenance	8 cycles + R maintenance until progression	357	95%	80%	42%	46.2	NR, 79.2% at 5 y	76
GIMEMA-MMY-3006 NCT01134484³¹ NDMM, age <65 y	VTd + double ASCT + VTd consolidation + dex maintenance	3 cycles +2 cycles consolidation post double ASCT + dexamethasone maintenance until progression/ tolerated	236	96%	89%	58%	60	NR	124.1
GIMEMA-MMY-3006 NCT01134484³¹ NDMM, age <65 y	Td + double ASCT + Td consolidation + dex maintenance		238	89%	74%	41%	41	110	124.1
GEM05menos65 NCT00461747³² NDMM, age <65 y	VTd + IFNα2b/T/ VT maintenance	24-week induction + ASCT + maintenance × 3 years	130	85% after induction	60% after induction	35% after induction	56.1	60% at 8 y	70.6
	Td + IFNα2b/T/ VT maintenance		127	62% after induction	29% after induction	14% after induction	29.2
	VBMCP/VBAD/ bortezomib + IFNα2b/T/VT maintenance		129	75% after induction	36% after induction	21% after induction	39.9
NCT00910897³³ NDMM, age <65 y	VTd + ASCT	4 cycles + ASCT	100	89% after ASCT	74% after ASCT	29% after ASCT	26		32
NCT00910897³³ NDMM, age <65 y	Vd + ASCT	4 cycles + ASCT	99	86% after ASCT	58% after ASCT	31% after ASCT	30	-	32
IFM2013-04 NCT01564537³⁴ NDMM, age <65 y	VCd	4 cycles	169	83.4% after induction	56.2% after induction	8.9% after induction	-	-	-
IFM2013-04 NCT01564537³⁴ NDMM, age <65 y	VTd	4 cycles	169	92.3% after induction	66.3% after induction	13% after induction	-		-
S0777 NCT00644228¹⁷ NDMM	VRd + Rd maintenance	8 cycles + Rd maintenance until progression/ tolerated	225	90.2%	74.9%	24.2%	41	NR	84
S0777 NCT00644228¹⁷ NDMM	Rd + Rd maintenance	6 cycles + Rd maintenance until progression/ tolerated	235	78.8%	53.2%	12.1%	29	69	84
UPFRONT NCT00507416³⁵ NDMM	Vd + V maintenance	8 cycles induction +35 weeks maintenance	168	73%	37%	3%	14.7	49.8	42.7
	VTd + V maintenance		167	80%	51%	4%	15.4	51.5
	VMP + V maintenance		167	70%	41%	4%	17.3	53.1
ENDURANCE NCT01863550²⁵ NDMM	VRd + R maintenance	12 cycles + maintenance × 2 years vs until progression/ tolerated	542	84% after induction	65% after induction	15% after induction	34.4 mo	NR, 84% at 3 y	26
ENDURANCE NCT01863550²⁵ NDMM	KRd + R maintenance	9 cycles + maintenance × 2 years vs until progression/ tolerated	545	87% after induction	74% after induction	18% after induction	34.6 mo	NR, 86% at 3 y	26
TOURMALINE-MM2 NCT01850524³⁶ NDMM	IRd	18 cycles + maintenance until progression/ tolerated	351	82.1%	63%	25.6%	35.3	NR	~58
	Placebo-Rd		351	82.1%	63%	25.6%	35.3	NR
	Placebo-Rd		354	79.7%	47.7%	14.1%	21.8	NR
MAIA NCT02252172³⁷ NDMM	DRd	Treatment continued until progression/ tolerated	368	92.9%	81%	51%	NR	NR	56.2
	Rd
	Rd		369	81.6%	57%	30%	34.4	NR

Only regimens with any 2 of the PIs, IMiDs, or anti-CD38 MoAbs are included.

CPR, cyclophosphamide, prednisone, lenalidomide; CR, complete response; CVD, cardiovascular disease; Dara, daratumumab; dex, dexamethasone; DRd, daratumumab, lenalidomide, dexamethasone; EFS, event-free survival; I, ixazomib; IRd, ixazomib, lenalidomide, dexamethasone; K, carfilzomib; KRd, carfilzomib, lenalidomide, dexamethasone; M, melphalan; MP, melphalan and prednisone; MPR, melphalan, prednisone, lenalidomide; MPT, melphalan, prednisone, thalidomide; NDMM, newly diagnosed multiple myeloma; NR, not reached; ORR, overall response rate; PR, prednisone and lenalidomide; > = PR, partial response or better; R, lenalidomide; Rd, lenalidomide and dexamethasone; s/c, subcutaneous; V, bortezomib; VAD, vincristine, doxorubicin, dexamethasone; Vd, bortezomib and dexamethasone; VGPR, very good partial response; VMP, bortezomib, melphalan, prednisone; VMPT, bortezomib, melphalan, prednisone, thalidomide; VRd, bortezomib, lenalidomide, dexamethasone; VT, bortezomib and thalidomide; VTd, bortezomib, thalidomide, dexamethasone.

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