Table 2. Main randomized clinical trials... | American Society of Hematology

Table 2.

Main randomized clinical trials assessing intensified regimens before transplant

Trial	Regimens	Efficacy	Safety
IFM phase 2 study²⁵	Mel 220 + anti-IL-6 vs Mel 220	CR: 37.5% vs 11%	One toxic death Grade 4 mucositis: 62.5%
NCT00217438²⁶	Mel 280 + amifostine vs Mel 200 + amifostine	ORR: 74% vs 57% (P = .04) mPFS: 3.5 y vs 2.7 y mOS: 6.2 y vs 5.3 y	Grade 2/3 mucositis: 33% vs 12% (P = .004)
German study²⁷	Mel 100 × 2 + Ida 20 × 3 + Cy 60 × 2 vs Mel 100 × 2	ORR: 85% vs 83% (P = .01) mEFS: 20 m vs 16 m (P = .08) mOS: 46 m vs 66 m (P = .02)	TRM: 20% vs 0% Grade 3/4 mucositis: 80% vs 27% (P < .01)
NCT01413178²⁸	Mel 70 × 2 + Bu × 4 vs Mel 200	mPFS: 64.7 m vs 43.5 m (P = .022) 3-y 8 OS: 91% vs 89%	Mucositis: 96% vs 49% (P < .0001) Febrile neutropenia: 71% vs 30% (P < .001)
IFM2014-02²⁹	Mel 200 + ortezomib × 4 vs Mel 200	CR: 23.4% vs 20.5%	Peripheral neuropathy: 4% vs 1.2%

Trial	Regimens	Efficacy	Safety
IFM phase 2 study²⁵	Mel 220 + anti-IL-6 vs Mel 220	CR: 37.5% vs 11%	One toxic death Grade 4 mucositis: 62.5%
NCT00217438²⁶	Mel 280 + amifostine vs Mel 200 + amifostine	ORR: 74% vs 57% (P = .04) mPFS: 3.5 y vs 2.7 y mOS: 6.2 y vs 5.3 y	Grade 2/3 mucositis: 33% vs 12% (P = .004)
German study²⁷	Mel 100 × 2 + Ida 20 × 3 + Cy 60 × 2 vs Mel 100 × 2	ORR: 85% vs 83% (P = .01) mEFS: 20 m vs 16 m (P = .08) mOS: 46 m vs 66 m (P = .02)	TRM: 20% vs 0% Grade 3/4 mucositis: 80% vs 27% (P < .01)
NCT01413178²⁸	Mel 70 × 2 + Bu × 4 vs Mel 200	mPFS: 64.7 m vs 43.5 m (P = .022) 3-y 8 OS: 91% vs 89%	Mucositis: 96% vs 49% (P < .0001) Febrile neutropenia: 71% vs 30% (P < .001)
IFM2014-02²⁹	Mel 200 + ortezomib × 4 vs Mel 200	CR: 23.4% vs 20.5%	Peripheral neuropathy: 4% vs 1.2%

Bu, busulfan; Cy 60, cyclophosphamide 60 mg/kg; Ida 20, idarubicine 20 mg/m²; mEFS, median EFS; mOS, median OS; mPFS, median PFS; Mel 280, melphalan 280 mg/m²; ORR, overall response rate; TRM, treatment-related mortality.

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