Patient characteristics
. | 15 mg twice daily . | 30 mg once daily . | Combined . |
|---|---|---|---|
| No. of patients | 35 | 67 | 102 |
| Median age, y (range) | 59 (38-76) | 60 (40-90) | 60 (38-90) |
| Male | 21 (60) | 43 (64) | 64 (63) |
| White | 30 (86) | 65 (97) | 95 (93) |
| Durie Salmon stage III at diagnosis | 15 (43) | 38 (57) | 53 (52) |
| ECOG PS 0-1 | 30 (86) | 61 (91) | 91 (89) |
| Relapsed and refractory patients | 20 (57) | 32 (48) | 53 (52) |
| Serum heavy chain isotype | |||
| IgG | 26 (74) | 32 (48) | 58 (57) |
| IgA | 4 (12) | 22 (33) | 26 (25) |
| IgM | 0 (0) | 1 (2) | 1 (1) |
| None | 5 (14) | 12 (17) | 17 (17) |
| Serum light chain isotype | |||
| Kappa | 24 (68) | 39 (58) | 63 (62) |
| Lambda | 9 (26) | 22 (33) | 31 (30) |
| None | 2 (6) | 6 (9) | 8 (8) |
| Urine light chain isotype | |||
| Kappa | 14 (40) | 26 (39) | 40 (39) |
| Lambda | 6 (17) | 15 (22) | 21 (21) |
| None | 14 (40) | 22 (33) | 36 (35) |
| Unknown | 1 (3) | 4 (6) | 5 (5) |
| Presence of lytic bone disease | 26 (74) | 55 (82) | 75 (74) |
| Median plasma cell involvement, % (range) | 46 (0-90) | 30 (1-95) | 31 (0-95) |
| Abnormal cytogenetics* | 10 (37) | 21 (38) | 31 (38) |
| Chromosome 13 deletion* | 5 (19) | 14 (24) | 19 (23) |
| Median laboratory values (range) | |||
| Serum albumin level, g/dL | 3.9 (2.6-4.6) | 3.8 (2.8-4.6) | 3.9 (2.6-4.6) |
| Hemoglobin level, g/dL | 11.6 (8.1-15.0) | 11.6 (6.8-14.6) | 11.6 (6.8-15.0) |
| LDH level, U/L | 424 (109-792) | 447 (72-1305) | 433 (72-1305) |
| Platelet count, × 109/L | 211 (87-352) | 204 (19-426) | 207 (19-426) |
| WBC count, × 109/L | 4.7 (2.5-13.4) | 4.6 (1.8-23.1) | 4.6 (1.8-23.1) |
| No. of prior therapies | |||
| 1 | 1 (3) | 2 (3) | 3 (3) |
| 2 | 3 (9) | 16 (24) | 19 (19) |
| 3 | 10 (28) | 13 (20) | 23 (22) |
| More than 3 | 21 (60) | 36 (53) | 57 (56) |
| Prior stem cell transplantation | 20 (57) | 42 (63) | 62 (61) |
| Prior thalidomide | 28 (80) | 49 (73) | 77 (76) |
| Prior bortezomib | 7 (21) | 11 (16) | 18 (18) |
. | 15 mg twice daily . | 30 mg once daily . | Combined . |
|---|---|---|---|
| No. of patients | 35 | 67 | 102 |
| Median age, y (range) | 59 (38-76) | 60 (40-90) | 60 (38-90) |
| Male | 21 (60) | 43 (64) | 64 (63) |
| White | 30 (86) | 65 (97) | 95 (93) |
| Durie Salmon stage III at diagnosis | 15 (43) | 38 (57) | 53 (52) |
| ECOG PS 0-1 | 30 (86) | 61 (91) | 91 (89) |
| Relapsed and refractory patients | 20 (57) | 32 (48) | 53 (52) |
| Serum heavy chain isotype | |||
| IgG | 26 (74) | 32 (48) | 58 (57) |
| IgA | 4 (12) | 22 (33) | 26 (25) |
| IgM | 0 (0) | 1 (2) | 1 (1) |
| None | 5 (14) | 12 (17) | 17 (17) |
| Serum light chain isotype | |||
| Kappa | 24 (68) | 39 (58) | 63 (62) |
| Lambda | 9 (26) | 22 (33) | 31 (30) |
| None | 2 (6) | 6 (9) | 8 (8) |
| Urine light chain isotype | |||
| Kappa | 14 (40) | 26 (39) | 40 (39) |
| Lambda | 6 (17) | 15 (22) | 21 (21) |
| None | 14 (40) | 22 (33) | 36 (35) |
| Unknown | 1 (3) | 4 (6) | 5 (5) |
| Presence of lytic bone disease | 26 (74) | 55 (82) | 75 (74) |
| Median plasma cell involvement, % (range) | 46 (0-90) | 30 (1-95) | 31 (0-95) |
| Abnormal cytogenetics* | 10 (37) | 21 (38) | 31 (38) |
| Chromosome 13 deletion* | 5 (19) | 14 (24) | 19 (23) |
| Median laboratory values (range) | |||
| Serum albumin level, g/dL | 3.9 (2.6-4.6) | 3.8 (2.8-4.6) | 3.9 (2.6-4.6) |
| Hemoglobin level, g/dL | 11.6 (8.1-15.0) | 11.6 (6.8-14.6) | 11.6 (6.8-15.0) |
| LDH level, U/L | 424 (109-792) | 447 (72-1305) | 433 (72-1305) |
| Platelet count, × 109/L | 211 (87-352) | 204 (19-426) | 207 (19-426) |
| WBC count, × 109/L | 4.7 (2.5-13.4) | 4.6 (1.8-23.1) | 4.6 (1.8-23.1) |
| No. of prior therapies | |||
| 1 | 1 (3) | 2 (3) | 3 (3) |
| 2 | 3 (9) | 16 (24) | 19 (19) |
| 3 | 10 (28) | 13 (20) | 23 (22) |
| More than 3 | 21 (60) | 36 (53) | 57 (56) |
| Prior stem cell transplantation | 20 (57) | 42 (63) | 62 (61) |
| Prior thalidomide | 28 (80) | 49 (73) | 77 (76) |
| Prior bortezomib | 7 (21) | 11 (16) | 18 (18) |
Unless otherwise indicated, data are number of patients, with the percentage in parentheses. WBC indicates white blood cell
Cytogenetics data available on 27 and 55 patients on 15- and 30-mg arms, respectively