Table 1.
Demographic and Baseline Disease Characteristics in the Intention-to-Treat Population.*
| Characteristic | Daratumumab Group (N = 368) | Control Group (N = 369) |
|---|---|---|
| Median age (range) — yr | 73.0 (50–90) | 74.0 (45–89) |
| Age category — no. (%) | ||
| <65 yr | 4 (1.1) | 4 (11) |
| 65 to <70 yr | 74 (20.1) | 73 (19.8) |
| 70 to <75 yr | 130 (35.3) | 131 (35.5) |
| ≥75 yr | 160 (43.5) | 161 (43.6) |
| ECOG performance status — no. (%)† | ||
| 0 | 127 (34.5) | 123 (33.3) |
| 1 | 178 (48.4) | 187 (50.7) |
| 2‡ | 63 (17.1) | 59 (16.0) |
| ISS disease stage — no. (%)§ | ||
| I | 98 (26.6) | 103 (27.9) |
| II | 163 (44.3) | 156 (42.3) |
| III | 107 (29.1) | 110 (29.8) |
| Type of measurable disease — no. (%) | ||
| IgG | 225 (61.1) | 231 (62.6) |
| IgA | 65 (17.7) | 66 (17.9) |
| Other¶ | 9 (2.4) | 10 (2.7) |
| Detected in urine only | 40 (10.9) | 34 (9.2) |
| Detected as serum free light-chain only | 29 (7.9) | 28 (7.6) |
| Cytogenetic profile — no./total no. (%)‖ | ||
| Standard risk | 271/319 (85.0) | 279/323 (86.4) |
| High risk | 48/319 (15.0) | 44/323 (13.6) |
| Median time since initial diagnosis of multiple myeloma (range) — mo | 0.95 (0.1–13.3) | 0.89 (0–14.5) |
The intention-to-treat population included all patients who underwent randomization. Post hoc analyses showed no significant differences between the two groups in the characteristics evaluated at baseline.
Eastern Cooperative Oncology Group (ECOG) performance status is scored on a scale from 0 to 5, with 0 indicating no symptoms and higher scores indicating increasing disability.
Two patients had a score of greater than 2 (one patient had a score of 3, and another patient had a score of 4).
The International Staging System (ISS) disease stage, which is derived on the basis of the combination of serum β2-microglobulin and albumin levels, consists of three stages. Higher stages indicate more severe disease.
This category includes IgD, IgE, IgM, and biclonal.
Cytogenetic risk was based on fluorescence in situ hybridization or karyotype analysis; patients who had a high-risk cytogenetic profile had at least one high-risk abnormality (del17p, t[14;16], or t[4;14]).