Table 1.
Characteristics of the 421 patients before HDM/SCT, the 81 patients who died during the first year after HDM/SCT, and the 340 evaluable for response
| All (N = 421) (100%) | Nonevaluable (N = 81) (19%) | Evaluable (N = 340; 81%) |
CR vs non-CR, P | ||
|---|---|---|---|---|---|
| CR (N = 145/340) (43%) | Non-CR (N = 195/340) (57%) | ||||
| Median age, y (range) | 56 (28-78) | 57 (35-76) | 56 (28-77) | 57 (32-78) | .11 |
| Patients ≥ 65 y old, no. (%) | 73 (17.3) | 15 (18.5) | 19 (13) | 39 (20) | .11 |
| Female sex, n (%) | 169 (40) | 30 (37) | 66 (45.5) | 73 (37) | .15 |
| Performance status, median (range) | 1 (0-3) | 1 (0-3) | 1 (0-3) | 1 (0-3) | — |
| No. of organs involved, median (range) | 2 (1-6) | 3 (1-6) | 2 (1-5) | 2 (1-6) | .13 |
| 1 organ, n (%) | 125 (30) | 5 (6.2) | 46 (32) | 74 (38) | .07 |
| 2 organs, n (%) | 115 (27) | 17 (21) | 37 (25) | 61 (31) | .07 |
| ≥ 3 organs, n (%) | 181 (43) | 59 (72.8) | 62 (43) | 60 (31) | .07 |
| % with organ involved | |||||
| Heart | 45 | 69 | 36 | 42 | .22 |
| Kidney | 84 | 86 | 88 | 81 | .07 |
| Liver | 27 | 44 | 31 | 17 | .004* |
| Gastrointestinal | 20 | 32 | 19 | 16 | .56 |
| Autonomic neuropathy | 26 | 38 | 24 | 23 | .89 |
| Peripheral neuropathy | 10 | 7 | 11 | 10 | .86 |
| Soft tissue | 22 | 33 | 17 | 21 | .40 |
| Lung | 4.5 | 7 | 4 | 3.6 | .78 |
| % BM plasma cells, median (range) | 5 (< 5-25) | 5 (5-25) | 5 (< 5-20) | 10 (2-25) | .39 |
| Light chain isotype | .004* | ||||
| κ, n (%) | 81 (19.2) | 13 (16) | 40 (27.6) | 28 (14) | |
| λ, n (%) | 340 (80.8) | 68 (84) | 105 (72.4) | 167 (86) | |
| Time from diagnosis to SCT, months, median (range) | 5.2 (1-143) | 5 (1-103) | 5.5 (1.5-143.5) | 5.1 (1.6-132.3) | .26 |
| Dose of melphalan, n (%) | .007* | ||||
| 200 mg/m2 | 231 (55) | 27 (33.3) | 99 (68.3) | 105 (54) | |
| 100-140 mg/m2 | 190 (45) | 54 (66.6) | 46 (31.7) | 90 (46) | |
| Tandem SCT “per protocol,” n (%) | 39 (9.2) | 1 (1.2) | 9 (6.2) | 29 (15) | .014* |
| Follow-up, y, median (range) | 4 (0-15.6) | 0.2 (0-0.9) | 6.9 (1-15.6) | 3.9 (1-13.9) | < .001* |
BM indicates bone marrow; and —, not applicable.
*
Statistically significant.