es 1 and 2 Study 1 Study 2
REVLIMID/Dex
N=177 Placebo/Dex
N=176 REVLIMID/Dex
N=176 Placebo/Dex
N=175
Patient Characteristics
Age (years)
Median 64 62 63 64
Min, Max 36, 86 37, 85 33, 84 40, 82
Sex
Male 106 (60%) 104 (59%) 104 (59%) 103 (59%)
Female 71 (40%) 72 (41%) 72 (41%) 72 (41%)
Race/Ethnicity
White 141(80%) 148 (84%) 172 (98%) 175(100%)
Other 36 (20%) 28 (16%) 4 (2%) 0 (0%)
ECOG Performance
Status 0-1 157 (89%) 168 (95%) 150 (85%) 144 (82%)
Disease Characteristics
Multiple Myeloma Stage (Durie-Salmon)
I 3% 3% 6% 5%
II 32% 31% 28% 33%
III 64% 66% 65% 63%
B2-microglobulin (mg/L)
≤ 2.5 mg/L 52 (29%) 51 (29%) 51 (29%) 48 (27%)
> 2.5 mg/L 125 (71%) 125 (71%) 125 (71%) 127 (73%)
Number of Prior Therapies
1 38% 38% 32% 33%
≥ 2 62% 62% 68% 67%
Types of Prior Therapies
Stem Cell Transplantation 62% 61% 55% 54%
Thalidomide 42% 46% 30% 38%
Dexamethasone 81% 71% 66% 69%
Bortezomib 11% 11% 5% 4%
Melphalan 33% 31% 56% 52%
Doxorubicin 55% 51% 56% 57%
The primary efficacy endpoint in both studies was time to progression (TTP). TTP was defined as the time from randomization to the first occurrence of progressive disease.
Preplanned interim analyses of both studies showed that the combination of REVLIMID/dexamethasone was significantly superior to dexamethasone alone for TTP. The studies were unblinded to allow patients in the placebo/dexamethasone group to receive treatment with the REVLIMID/dexamethasone combination. For both studies, the extended follow-up survival data with crossovers were analyzed. In study 1, the median survival time was 39.4 months (95%CI: 32.9, 47.4) in REVLIMID/dexamethasone group and 31.6 months (95%CI: 24.1, 40.9) in placebo/dexamethasone group, with a hazard ratio of 0.79 (95% CI: 0.61-1.03). In study 2, the median survival time was 37.5 months (95%CI: 29.9, 46.6) in REVLIMID/dexamethasone group and 30.8 months (95%CI: 23.5, 40.3) in placebo/dexamethasone group, with a hazard ratio of 0.86 (95% CI: 0.65-1.14).
Table 9. TTP Results in Study 1 and Study 2 Study 1 Study 2
REVLIMID/Dex
N=177 Placebo/Dex
N=176 REVLIMID/Dex
N=176 Placebo/Dex
N=175
TTP
Events n (%) 73 (41) 120 (68) 68 (39) 130 (74)
Median TTP in months
[95% CI] 13.9
[9.5, 18.5] 4.7
[3.7, 4.9] 12.1
[9.5, NE] 4.7
[3.8, 4.8]
Hazard Ratio
[95% CI] 0.285
[0.210, 0.386] 0.324
[0.240, 0.438]
Log-rank Test p-value 3 <0.001 <0.001
Response
Complete Response (CR) n (%) 23 (13) 1 (1) 27 (15) 7 (4)
Partial Response (RR/PR) n (%) 84 (48) 33 (19) 77 (44) 34 (19)
Overall Response n (%) 107 (61) 34 (19) 104 (59) 41 (23)
p-value <0.001 <0.001
Odds Ratio [95% CI] 6.38
[3.95, 10.32] 4.72
[2.98, 7.49]
14.2.Myelodysplastic Syndromes (MDS) with a Deletion 5q Cytogenetic Abnormality
The efficacy and safety of REVLIMID were eva luated in patients with transfusion-dependent anemia in low- or intermediate-1- risk MDS with a 5q (q31-33) cytogenetic abnormality in isolation or with additional cytogenetic abnormalities, at a dose of 10 mg once daily or 10 mg once daily for 21 days every 28 days in an open-label, single-arm, multi
