Demographics and baseline disease characteristics for patients treated at the recommended doses on each schedule or at lower doses on either schedule
| . | Recommended dose groups . | Lower doses (N = 18) . | |
|---|---|---|---|
| 1.6 mg/m2 QW (N = 18) . | 1.3 mg/m2 BIW (N = 34) . | ||
| Median age (range) | 56.5 (45-74) | 67.0 (42-80) | 58.0 (38-77) |
| Age ≥ 65 y, n (%) | 3 (17) | 18 (53) | 6 (33) |
| Male, n (%) | 8 (44) | 21 (62) | 10 (56) |
| White, n (%) | 17 (94) | 30 (88) | 16 (89) |
| Karnofsky Performance Status < 90%, n (%) | 7 (39) | 13 (38) | 7 (39) |
| Median time since initial diagnosis, mo (range) | 27 (7-92) | 28 (3-163) | 32 (10-95) |
| No. of organs involved, n (%) | |||
| 1 | 2 (11) | 8 (24) | 4 (22) |
| 2 | 6 (33) | 13 (38) | 6 (33) |
| ≥ 3 | 10 (56) | 13 (38) | 8 (45) |
| Specific organ involvement, n (%) | |||
| Renal | 10 (56) | 27 (79) | 14 (78) |
| Cardiac | 10 (56) | 20 (59) | 9 (50) |
| Hepatic | 4 (22) | 4 (12) | 1 (6) |
| Gastrointestinal | 9 (50) | 8 (24) | 3 (17) |
| Neurologic | 2 (11) | 2 (6) | 3 (17) |
| Other* | 11 (61) | 14 (41) | 11 (61) |
| Any cardiac history, n (%) | 9 (50) | 11 (32) | 4 (22) |
| Any neurologic history, n (%) | 12 (67) | 18 (53) | 11 (61) |
| Median baseline creatinine clearance, mL/min (range) | 88 (44-153) | 74 (23-146) | 69 (29-149) |
| Prior AL treatment, n (%) | 18 (100) | 34 (100) | 18 (100) |
| Melphalan | 17 (94) | 33 (97) | 17 (94) |
| High-dose therapy plus stem cell transplantation | 12 (67) | 17 (50) | 11 (61) |
| Glucocorticoids | 16 (89) | 25 (74) | 16 (89) |
| Thalidomide/lenalidomide | 7 (39) | 9 (26) | 10 (56) |
| . | Recommended dose groups . | Lower doses (N = 18) . | |
|---|---|---|---|
| 1.6 mg/m2 QW (N = 18) . | 1.3 mg/m2 BIW (N = 34) . | ||
| Median age (range) | 56.5 (45-74) | 67.0 (42-80) | 58.0 (38-77) |
| Age ≥ 65 y, n (%) | 3 (17) | 18 (53) | 6 (33) |
| Male, n (%) | 8 (44) | 21 (62) | 10 (56) |
| White, n (%) | 17 (94) | 30 (88) | 16 (89) |
| Karnofsky Performance Status < 90%, n (%) | 7 (39) | 13 (38) | 7 (39) |
| Median time since initial diagnosis, mo (range) | 27 (7-92) | 28 (3-163) | 32 (10-95) |
| No. of organs involved, n (%) | |||
| 1 | 2 (11) | 8 (24) | 4 (22) |
| 2 | 6 (33) | 13 (38) | 6 (33) |
| ≥ 3 | 10 (56) | 13 (38) | 8 (45) |
| Specific organ involvement, n (%) | |||
| Renal | 10 (56) | 27 (79) | 14 (78) |
| Cardiac | 10 (56) | 20 (59) | 9 (50) |
| Hepatic | 4 (22) | 4 (12) | 1 (6) |
| Gastrointestinal | 9 (50) | 8 (24) | 3 (17) |
| Neurologic | 2 (11) | 2 (6) | 3 (17) |
| Other* | 11 (61) | 14 (41) | 11 (61) |
| Any cardiac history, n (%) | 9 (50) | 11 (32) | 4 (22) |
| Any neurologic history, n (%) | 12 (67) | 18 (53) | 11 (61) |
| Median baseline creatinine clearance, mL/min (range) | 88 (44-153) | 74 (23-146) | 69 (29-149) |
| Prior AL treatment, n (%) | 18 (100) | 34 (100) | 18 (100) |
| Melphalan | 17 (94) | 33 (97) | 17 (94) |
| High-dose therapy plus stem cell transplantation | 12 (67) | 17 (50) | 11 (61) |
| Glucocorticoids | 16 (89) | 25 (74) | 16 (89) |
| Thalidomide/lenalidomide | 7 (39) | 9 (26) | 10 (56) |
BIW indicates twice weekly; and QW, once weekly.
Other sites of involvement included lymph nodes, macroglossia, skin, lips, and tongue.