Baseline demographic and clinical characteristics
| Characteristic . | 1200 mg (n = 8) . | 1800 mg (n = 45) . |
|---|---|---|
| Age, y | ||
| Median (range) | 65.5 (49-78) | 63.0 (36-79) |
| ≥75 y, n (%) | 1 (12.5) | 4 (8.9) |
| Weight, median (range), kg | 75.0 (53.0-82.5) | 74.8 (48.0-133.0) |
| Baseline ECOG status, n (%) | ||
| 0 | 2 (25.0) | 11 (24.4) |
| 1 | 5 (62.5) | 33 (73.3) |
| 2 | 1 (12.5) | 1 (2.2) |
| ISS stage at screening, n (%)* | ||
| N | 6 | 45 |
| I | 1 (16.7) | 21 (46.7) |
| II | 3 (50.0) | 15 (33.3) |
| III | 2 (33.3) | 9 (20.0) |
| Time since diagnosis, median (range), y | 6.55 (1.9-10.3) | 5.94 (1.1-15.2) |
| IgG myeloma, n (%) | 3 (37.5) | 30 (66.7) |
| Previous lines of therapy, n (%) | ||
| Median (range) | 5 (2-10) | 4 (2-11) |
| ≤3 | 3 (37.5) | 16 (35.6) |
| >3 | 5 (62.5) | 29 (64.4) |
| Previous ASCT, n (%) | 5 (62.5) | 37 (82.2) |
| Previous IMiD, n (%) | 8 (100) | 45 (100) |
| Previous lenalidomide, n (%) | 8 (100) | 45 (100) |
| Previous PI, n (%) | 8 (100) | 45 (100) |
| Previous bortezomib | 8 (100) | 44 (97.8) |
| Refractory to, n (%) | ||
| PI only | 0 | 1 (2.2) |
| IMiD only | 1 (12.5) | 7 (15.6) |
| Both PI and IMiD | 5 (62.5) | 29 (64.4) |
| Last line of therapy | 7 (87.5) | 36 (80.0) |
| Cytogenetic risk, n (%)† | ||
| N | 8 | 37 |
| Standard risk | 4 (50.0) | 30 (81.1) |
| High risk | 4 (50.0) | 7 (18.9) |
| del17p | 3 (37.5) | 5 (13.5) |
| t(4;14) | 2 (25.0) | 3 (8.1) |
| t(14;16) | 0 | 0 |
| Characteristic . | 1200 mg (n = 8) . | 1800 mg (n = 45) . |
|---|---|---|
| Age, y | ||
| Median (range) | 65.5 (49-78) | 63.0 (36-79) |
| ≥75 y, n (%) | 1 (12.5) | 4 (8.9) |
| Weight, median (range), kg | 75.0 (53.0-82.5) | 74.8 (48.0-133.0) |
| Baseline ECOG status, n (%) | ||
| 0 | 2 (25.0) | 11 (24.4) |
| 1 | 5 (62.5) | 33 (73.3) |
| 2 | 1 (12.5) | 1 (2.2) |
| ISS stage at screening, n (%)* | ||
| N | 6 | 45 |
| I | 1 (16.7) | 21 (46.7) |
| II | 3 (50.0) | 15 (33.3) |
| III | 2 (33.3) | 9 (20.0) |
| Time since diagnosis, median (range), y | 6.55 (1.9-10.3) | 5.94 (1.1-15.2) |
| IgG myeloma, n (%) | 3 (37.5) | 30 (66.7) |
| Previous lines of therapy, n (%) | ||
| Median (range) | 5 (2-10) | 4 (2-11) |
| ≤3 | 3 (37.5) | 16 (35.6) |
| >3 | 5 (62.5) | 29 (64.4) |
| Previous ASCT, n (%) | 5 (62.5) | 37 (82.2) |
| Previous IMiD, n (%) | 8 (100) | 45 (100) |
| Previous lenalidomide, n (%) | 8 (100) | 45 (100) |
| Previous PI, n (%) | 8 (100) | 45 (100) |
| Previous bortezomib | 8 (100) | 44 (97.8) |
| Refractory to, n (%) | ||
| PI only | 0 | 1 (2.2) |
| IMiD only | 1 (12.5) | 7 (15.6) |
| Both PI and IMiD | 5 (62.5) | 29 (64.4) |
| Last line of therapy | 7 (87.5) | 36 (80.0) |
| Cytogenetic risk, n (%)† | ||
| N | 8 | 37 |
| Standard risk | 4 (50.0) | 30 (81.1) |
| High risk | 4 (50.0) | 7 (18.9) |
| del17p | 3 (37.5) | 5 (13.5) |
| t(4;14) | 2 (25.0) | 3 (8.1) |
| t(14;16) | 0 | 0 |
ASCT, autologous stem cell transplantation; IgG, immunoglobulin G; IMiD, immunomodulatory drug; ISS, International Staging System; PI, proteasome inhibitor.
ISS staging was derived based on the combination of serum β2-microglobulin and albumin.
Cytogenetic abnormalities were based on fluorescence in situ hybridization or karyotype testing.