Kaplan-Meier Curves of Progression-free Survival From Randomization (ITT Post-ASCT Population) in Maintenance Study 2

Auto-HSCT = autologous hematopoietic stem cell transplantation; CI = confidence interval; HR = hazard ratio; ITT = intent to treat; KM = Kaplan-Meier; NE = not estimable; PFS = progression-free survival; vs = versus

Randomized, Open-Label Clinical Studies in Patients with MM After At Least One Prior Therapy 

Two randomized studies (Studies 1 and 2) were conducted to eva luate the efficacy and safety of REVLIMID. These multicenter, multinational, double-blind, placebo-controlled studies compared REVLIMID plus oral pulse high-dose dexamethasone therapy to dexamethasone therapy alone in patients with MM who had received at least one prior treatment. These studies enrolled patients with absolute neutrophil counts (ANC) ≥ 1000/mm3, platelet counts ≥ 75,000/mm3, serum creatinine ≤ 2.5 mg/dL, serum SGOT/AST or SGPT/ALT ≤ 3 x upper limit of normal (ULN), and serum direct bilirubin ≤ 2 mg/dL.

In both studies, patients in the REVLIMID/dexamethasone group took 25 mg of REVLIMID orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle. Patients in the placebo/dexamethasone group took 1 placebo capsule on Days 1 to 28 of each 28-day cycle. Patients in both treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy.

The dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 of each 28-day cycle after the first 4 cycles of therapy. In both studies, treatment was to continue until disease progression.

In both studies, dose adjustments were allowed based on clinical and laboratory findings. Sequential dose reductions to 15 mg daily, 10 mg daily and 5 mg daily were allowed for toxicity [see Dosage and Administration (2.1)].

Table 15 summarizes the baseline patient and disease characteristics in the two studies. In both studies, baseline demographic and disease-related characteristics were comparable between the REVLIMID/dexamethasone and placebo/dexamethasone groups.

Table 15: Baseline Demographic and Disease-Related Characteristics – Studies 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
    Min, Max 64
36, 86 62
37, 85 63
33, 84 64
40, 82
Sex
    Male
    Female 106 (60%)
71 (40%) 104 (59%)
72 (41%) 104 (59%)
72 (41%) 103 (59%)
72 (41%)
Race/Ethnicity
    White
    Other 141(80%)
36 (20%) 148 (84%)
28 (16%) 172 (98%)
4 (2%) 175(100%)
0 (0%)
ECOG Performance
Status 0-1 157 (89%) 168 (95%) 150 (85%) 144 (82%)
Disease Characteristics
Multiple Myeloma Stage (Durie-
Salmon)
                          I
                          II