Table 1 Summary of available clinical efficacy data of pomalidomide in multiple myeloma trials

From: Spotlight on pomalidomide: could less be more?

Trial Ph N Regimen Dose schedule/MTD ORR % DCR % ( SD) Neutropeniagrade 3 PFS; OS (months)
Schey et al.4 I 24 Pom MTD=2 mg per day 54 >90 58% (patients taking > 2mg 100%) 9.7; 22.5
Streetly et al.5 I 20 Pom ± Dex MTD=5 mg on alternate days 50 90 45% 10.5; 33
Richardson et al.8 I 38 Pom ± Dex MTD=4 mg 21 NA 53% (patients taking > 2mg 60%) 4.6; 18.3
Lacy et al.6 II 60 Pom/Dex 2 mg (28/28)+DXM 63 88 31% 11.6; 76% at 2 years
Leleu et al. 13 II        
Arm A   43 Pom/Dex 4 mg (21/28)+DXM 30 79 65% NA
Arm B   40 Pom/Dex 4 mg (28/28)+DXM 47 85 58% NA
Lacy et al. 7 II        
Cohort A   35 Pom/Dex 2 mg (28/28)+DXM 49 82 51% 6.5; 78% at 6 months
Cohort B   35 Pom/Dex 4 mg (28/28)+DXM 43 74 66% 3.2; 67% at 6 months
San Miguel MM-003 1 III        
Cohort A   302 Pom/Dex 4 mg (21/28)+DXM 21 82 48% 4.0; 12.7
Cohort B   153 Dex DXM 3 62 16% 1.9; 8.1
Sehgal et al. 9 II        
Cohort 1   19 Pom/Dex 2mg (28/28) 21 NA 42% 4.3; 21.7
Cohort 2   20 Pom/Dex 4mg (21/28) 45 NA 45% 5.1; 17.7
  1. Abbreviations: DCR, disease control rate; DXM, dexamethasone; MTD, maximum tolerated dose; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; SD, stable disease.