Table 1.
Baseline patient characteristics
| Primary efficacy population (n = 187) | Safety population (N = 199) | |
|---|---|---|
| Median age, years (range) |
60 (35–81) |
59 (35–81) |
| Age distribution, n (%) | ||
| ≤65 years |
133 (71.1) |
142 (71.4) |
| >65 years |
54 (28.9) |
57 (28.6) |
| Male, n (%) |
116 (62.0) |
125 (62.8) |
| Durie-Salmon baseline MM stage, n (%) | ||
| I |
9 (4.8) |
9 (4.5) |
| II |
18 (9.6) |
19 (9.6) |
| III |
160 (85.6) |
171 (85.9) |
| ECOG Performance Status score, n (%) | ||
| 0 |
69 (36.9) |
73 (36.7) |
| 1 |
92 (49.2) |
99 (49.7) |
| 2 |
26 (13.9) |
27 (13.6) |
| Renal function (creatinine clearance), n (%) | ||
| Normal (≥60 ml/min) |
125 (66.8) |
131 (65.8) |
| Mild-to-moderate impairment (≥30 to <60 ml/min) |
50 (26.7) |
54 (27.1) |
| Severe impairment (<30 ml/min) |
12 (6.4) |
14 (7.0) |
| Median number of prior antimyeloma therapies, n (range) |
4 (1–15) |
4 (1–15) |
| Number of prior antimyeloma therapies, n (%) | ||
| 1–3 |
81 (43.3) |
86 (43.2) |
| 4–6 |
64 (34.2) |
68 (34.2) |
| 7–9 |
29 (15.5) |
32 (16.1) |
| 10–15 |
13 (7.0) |
13 (6.5) |
| Prior use of thalidomide or bortezomib, n (%) | ||
| Thalidomide |
130 (69.5) |
137 (68.8) |
| Bortezomib |
118 (63.1) |
127 (63.8) |
| Thalidomide and bortezomib |
84 (44.9) |
90 (45.2) |
| Type of MM, n (%) | ||
| IgA |
50 (26.7) |
55 (27.6) |
| IgD |
10 (5.4) |
10 (5.0) |
| IgG |
107 (57.2) |
112 (56.3) |
| IgM |
1 (0.5) |
1 (0.5) |
| Missing | 19 (10.2) | 21 (10.6) |
Abbreviations: ECOG Eastern Cooperative Oncology Group, Ig immunoglobulin, MM multiple myeloma.