The demographics and disease-related baseline characteristics of the patients were similar across the two studies and reflected a typical MM population after auto-HSCT (see Table 13).
 

Table 13: Baseline Demographic and Disease-Related Characteristics – Maintenance Studies 1 and 2

Data cutoff date = 1 March 2015.

 Maintenance Study 1 Maintenance Study 2
 REVLIMID
N = 231 Placebo
N = 229 REVLIMID
N = 307 Placebo
N = 307
Age (years)        
        Median 58.0 58.0 57.5 58.1
        (Min, max) (29.0, 71.0) (39.0, 71.0) (22.7, 68.3) (32.3, 67.0)
Sex, n (%)        
        Male 121 (52) 129 (56) 169 (55) 181 (59)
        Female 110 (48) 100 (44) 138 (45) 126 (41)
ISS Stage at Diagnosis,
n (%)        
        Stage I or II 120 (52) 131 (57) 232 (76) 250 (81)
            Stage I 62 (27) 85 (37) 128 (42) 143 (47)
            Stage II 58 (25) 46 (20) 104 (34) 107 (35)
        Stage III 39 (17) 35 (15) 66 (21) 46 (15)
        Missing 72 (31) 63 (28) 9 (3) 11 (4)
CrCl at Post-auto-HSCT,
n (%)        
        < 50 mL/min 23 (10) 16 (7) 10 (3) 9 (3)
        ≥ 50 mL/min 201 (87) 204 (89) 178 (58) 200 (65)
        Missing 7 (3) 9 (4) 119 (39) 98 (32)

The major efficacy endpoint of both studies was PFS defined from randomization to the date of progression or death, whichever occurred first; the individual studies were not powered for an overall survival endpoint. Both studies were unblinded upon the recommendations of their respective data monitoring committees and after surpassing the respective thresholds for preplanned interim analyses of PFS. After unblinding, patients continued to be followed as before. Patients in the placebo arm of Maintenance Study 1 were allowed to cross over to receive REVLIMID before disease progression (76 patients [33%] crossed over to REVLIMID); patients in Maintenance Study 2 were not recommended to cross over. The efficacy results are summarized in the following table. In both studies, the primary analysis of PFS at unblinding was significantly longer with REVLIMID compared to placebo: Maintenance Study 1 HR 0.38 (95% CI: 0.27-0.54 p <0.001) and Maintenance Study 2 HR 0.50 (95% CI: 0.39-0.64 p <0.001). For both studies, PFS was updated with a cutoff date of 1 March 2015 as shown in the table and the following Kaplan Meier graphs. With longer follow-up (median 72.4 and 86.0 months, respectively), the updated PFS analyses for both studies continue to show a PFS advantage for REVLIMID compared to placebo: Maintenance Study 1 HR 0.38 (95% CI: 0.28-0.50) with median PFS of 68.6 months an