Table 1. Doublet regimens in randomized... | American Society of Hematology

Table 1.

Doublet 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)
NCT00057564²⁶ NDMM	Td	Continued until progression/ toxicity	235	63%	15.8%	7.7% -	14.9	NR (75.7% at 18 mo)	18
NCT00057564²⁶ NDMM	Placebo-dex	Continued until progression/ toxicity	235	46%	43.8%	2.6% -	6.5	NR (71.1% at 18 mo)	18
IFM 2005-01 NCT00200681²⁷ NDMM, age < = 65 years	VAD + ASCT + DCEP vs no consolidation	4 cycles + ASCT +2 cycles consolidation vs no consolidation	242	77.1% after ASCT	37.2% after ASCT	8.7% after ASCT -	29.7	NR (77.4% at 3 y)	32.2
IFM 2005-01 NCT00200681²⁷ NDMM, age < = 65 years	Bd + ASCT + DCEP vs no consolidation	4 cycles + ASCT +2 cycles consolidation vs no consolidation	240	80.3% after ASCT	54.3% after ASCT	16.1% after ASCT -	36	NR (81.4% at 3 y)	32.2
NCT00551928²⁸ NDMM, age < = 65 years	Rd + MPR + R/no maintenance	Induction × 4 cycles + MPR × 6 cycles + maintenance until progression/ tolerated	132	90.9%	62.9%	18.2% -	22.4	NR, 65.3% at 4 y	51.2
NCT00551928²⁸ NDMM, age < = 65 years	Rd + ASCT + R/no maintenance	Induction × 4 cycles + ASCT + maintenance till progression/ tolerated	141	92.9%	58.9%	23.4% -	43	NR, 81.6% at 4 y	51.2
RV-MM-EMN-441 NCT01091831²⁹ NDMM, age < = 65 years	Rd + CRd + R/PR maintenance	Induction × 4 cycles + CRd × 6 cycles + maintenance until progression/ tolerated	129	89%	50%	12% -	28.6	NR, 73% at 4 y	52
RV-MM-EMN-441 NCT01091831²⁹ NDMM, age < = 65 years	Rd + ASCT + R/PR maintenance	Induction × 4 cycles + ASCT + maintenance until progression/ tolerated	127	91%	54%	13% -	43.3	NR, 86% at 4 y	52
NCT01093196³⁰ NDMM	Rd + R vs PR maintenance	9 cycles + maintenance till progression/ tolerated	217	74%	34%	3%	21	NR, 58% at 4 y	39
NCT01093196³⁰ NDMM	MPR/CPR + R vs PR maintenance	9 cycles + maintenance till progression/ tolerated	437	MPR = 71%, CPR = 68%	MPR = 26%, CPR = 20.5%	MPR = 3%, CPR = 0.5%	22	NR, 67% at 4 y	39
FIRST NCT00689936²⁰ NDMM	Rd until progression	Until progression/ tolerated	535	81%	48%	22%	26	59.1	67
	Rd × 18 cycles	18 cycles	541	79%	47%	20%	21	62.3
	MPT	12 cycles	547	67%	30%	12%	21.9	49.1

Trial	Regimen	Duration of treatment	N	ORR	> = VGPR	> = CR	Median PFS (months)	Median OS (months)	Median follow up (months)
NCT00057564²⁶ NDMM	Td	Continued until progression/ toxicity	235	63%	15.8%	7.7% -	14.9	NR (75.7% at 18 mo)	18
NCT00057564²⁶ NDMM	Placebo-dex	Continued until progression/ toxicity	235	46%	43.8%	2.6% -	6.5	NR (71.1% at 18 mo)	18
IFM 2005-01 NCT00200681²⁷ NDMM, age < = 65 years	VAD + ASCT + DCEP vs no consolidation	4 cycles + ASCT +2 cycles consolidation vs no consolidation	242	77.1% after ASCT	37.2% after ASCT	8.7% after ASCT -	29.7	NR (77.4% at 3 y)	32.2
IFM 2005-01 NCT00200681²⁷ NDMM, age < = 65 years	Bd + ASCT + DCEP vs no consolidation	4 cycles + ASCT +2 cycles consolidation vs no consolidation	240	80.3% after ASCT	54.3% after ASCT	16.1% after ASCT -	36	NR (81.4% at 3 y)	32.2
NCT00551928²⁸ NDMM, age < = 65 years	Rd + MPR + R/no maintenance	Induction × 4 cycles + MPR × 6 cycles + maintenance until progression/ tolerated	132	90.9%	62.9%	18.2% -	22.4	NR, 65.3% at 4 y	51.2
NCT00551928²⁸ NDMM, age < = 65 years	Rd + ASCT + R/no maintenance	Induction × 4 cycles + ASCT + maintenance till progression/ tolerated	141	92.9%	58.9%	23.4% -	43	NR, 81.6% at 4 y	51.2
RV-MM-EMN-441 NCT01091831²⁹ NDMM, age < = 65 years	Rd + CRd + R/PR maintenance	Induction × 4 cycles + CRd × 6 cycles + maintenance until progression/ tolerated	129	89%	50%	12% -	28.6	NR, 73% at 4 y	52
RV-MM-EMN-441 NCT01091831²⁹ NDMM, age < = 65 years	Rd + ASCT + R/PR maintenance	Induction × 4 cycles + ASCT + maintenance until progression/ tolerated	127	91%	54%	13% -	43.3	NR, 86% at 4 y	52
NCT01093196³⁰ NDMM	Rd + R vs PR maintenance	9 cycles + maintenance till progression/ tolerated	217	74%	34%	3%	21	NR, 58% at 4 y	39
NCT01093196³⁰ NDMM	MPR/CPR + R vs PR maintenance	9 cycles + maintenance till progression/ tolerated	437	MPR = 71%, CPR = 68%	MPR = 26%, CPR = 20.5%	MPR = 3%, CPR = 0.5%	22	NR, 67% at 4 y	39
FIRST NCT00689936²⁰ NDMM	Rd until progression	Until progression/ tolerated	535	81%	48%	22%	26	59.1	67
	Rd × 18 cycles	18 cycles	541	79%	47%	20%	21	62.3
	MPT	12 cycles	547	67%	30%	12%	21.9	49.1

Only regimens with any 1 of the PIs, IMiDs, or anti-CD38 MoAbs are included.

CPR, cyclophosphamide, prednisone, lenalidomide; CR, complete response; CVD, cardiovascular disease; dex, dexamethasone; EFS, event-free survival; MPR, melphalan, prednisone, lenalidomide; MPT, melphalan; 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.

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