Response measured by response assessment per protocol and by paraprotein (M spike) measurement based on the starting dose of 30 or 25 mg
| . | All patients, N = 36 (%) . | 30 mg, n = 24 (%) . | 25 mg, n = 12 (%) . |
|---|---|---|---|
| Best overall response, n (%) | |||
| CR | 0 (0) | 0 (0) | 0 (0) |
| VGPR | 0 (0) | 0 (0) | 0 (0) |
| PR | 8 (22) | 7 (29) | 1 (8) |
| MR | 9 (25) | 5 (21) | 4 (33) |
| SD | 18 (50) | 11 (46) | 8 (58) |
| PD | 0 (0) | 0 (0) | 0 (0) |
| Not evaluable | 1 (3) | 1 (4) | 0 (0) |
| Total | 36 | 24 | 12 |
| PR or better | 8 (22; 90% CI,12-37) | 7 (29; 90% CI, 15-48) | 1 (8; 90% CI, 0-34) |
| MR or better | 17 (47; 90% CI, 33-62) | 12 (50; 90% CI, 32-68) | 5 (41; 90% CI, 18-68) |
| Best paraprotein response, n (%) | |||
| CR | 0 (0) | 0 (0) | 0 (0) |
| VGPR | 1 (3) | 1 (4) | 0 (0) |
| PR | 10 (27) | 9 (38) | 1 (8) |
| MR | 9 (25) | 5 (21) | 4 (33) |
| SD | 14 (39) | 7 (29) | 7 (58) |
| PD | 1 (3) | 1 (4) | 0 (0) |
| Not evaluable | 1 (3) | 1 (4) | 0 (0) |
| Total | 36 | 24 | 12 |
| PR or better | 11 (30; 90% CI, 18-46) | 10 (42; 90% CI, 25-60) | 1 (8; 90% CI, 0-34) |
| MR or better | 20 (55; 90% CI, 41-70) | 15 (63; 90% CI, 44-79) | 5 (41; 90% CI, 18-68) |
| . | All patients, N = 36 (%) . | 30 mg, n = 24 (%) . | 25 mg, n = 12 (%) . |
|---|---|---|---|
| Best overall response, n (%) | |||
| CR | 0 (0) | 0 (0) | 0 (0) |
| VGPR | 0 (0) | 0 (0) | 0 (0) |
| PR | 8 (22) | 7 (29) | 1 (8) |
| MR | 9 (25) | 5 (21) | 4 (33) |
| SD | 18 (50) | 11 (46) | 8 (58) |
| PD | 0 (0) | 0 (0) | 0 (0) |
| Not evaluable | 1 (3) | 1 (4) | 0 (0) |
| Total | 36 | 24 | 12 |
| PR or better | 8 (22; 90% CI,12-37) | 7 (29; 90% CI, 15-48) | 1 (8; 90% CI, 0-34) |
| MR or better | 17 (47; 90% CI, 33-62) | 12 (50; 90% CI, 32-68) | 5 (41; 90% CI, 18-68) |
| Best paraprotein response, n (%) | |||
| CR | 0 (0) | 0 (0) | 0 (0) |
| VGPR | 1 (3) | 1 (4) | 0 (0) |
| PR | 10 (27) | 9 (38) | 1 (8) |
| MR | 9 (25) | 5 (21) | 4 (33) |
| SD | 14 (39) | 7 (29) | 7 (58) |
| PD | 1 (3) | 1 (4) | 0 (0) |
| Not evaluable | 1 (3) | 1 (4) | 0 (0) |
| Total | 36 | 24 | 12 |
| PR or better | 11 (30; 90% CI, 18-46) | 10 (42; 90% CI, 25-60) | 1 (8; 90% CI, 0-34) |
| MR or better | 20 (55; 90% CI, 41-70) | 15 (63; 90% CI, 44-79) | 5 (41; 90% CI, 18-68) |