Baseline and disease characteristics, and efficacy data in the total populations in the 025, 039, and 040 trials and in the pharmacogenomics/nonpharmacogenomics cohorts from each trial
| Variable . | Overall . | Nongenomics . | Genomics . | P, genomics vs nongenomics . |
|---|---|---|---|---|
| Trial 025 | ||||
| Overall survival, d* | 518.0 (434.0-643.0) | 533.0 (441.0-787.0) | 434.0 (237.0-628.0) | .06 |
| Time to progression, d* | 158.0 (119.0-213.0) | 210.0 (154.0-377.0) | 83.0 (60.0-139.0) | .03 |
| Response rate, CR + PR, %† | 30.1 | 30.0 | 30.2 | > .999 |
| Response rate, CR + PR + MR, %† | 40.4 | 40.7 | 39.5 | > .999 |
| Albumin level, g/L‡ | 35.2 (34.43-36.01) | 35.8 (34.87-36.64) | 33.4 (31.62-35.07) | .01 |
| Platelet count, × 109/L‡ | 170.5 (157.11-183.84) | 170.7 (155.22-186.27) | 169.5 (142.72-196.28) | .91 |
| C-reactive protein level, mg/L‡ | 13.0 (10.56-15.43) | 12.0 (9.45-14.45) | 16.5 (9.85-23.11) | .32 |
| β-2 Microglobulin level, μg/mL‡ | 5.6 (3.97-7.16) | 4.9 (3.91-5.91) | 7.8 (1.57-14.01) | .63 |
| Prior lines, n‡ | 4.5 (4.27-4.81) | 4.5 (4.24-4.82) | 4.6 (3.90-5.24) | .71 |
| Age at randomization, y‡ | 60.2 (58.87-61.45) | 60.5 (59.05-61.97) | 58.9 (56.03-61.74) | .47 |
| Male, %† | 60.5 | 59.1 | 65.9 | .49 |
| IgG, %† | 47.9 | 46.8 | 52.3 | .61 |
| Plasma cells in bone marrow aspirate, %‡ | 35.7 (30.9-40.5) | 30.0 (24.8-35.1) | 53.8 (43.9-63.7) | .001 |
| Trial 039§ | ||||
| Overall survival, d* | 773.0 (692.0-912.0) | 836.0 (694.0-NA) | 685.0 (565.0-NA) | .25 |
| Time to progression, d* | 147.0 (126.0-168.0) | 148.0 (127.0-170.0) | 127.0 (97.0-171.0) | .46 |
| Response rate, CR + PR, %† | 28.2 | 27.2 | 31.7 | .29 |
| Response rate, CR + PR + MR, %† | 40.5 | 39.6 | 43.4 | .44 |
| Albumin level, g/L‡ | 38.6 (38.16-39.04) | 38.8 (38.30-39.22) | 38.1 (36.97-39.17) | .43 |
| Platelet count, × 109/L‡ | 193.8 (187.61-200.00) | 197.9 (190.85-204.99) | 180.4 (167.63-193.14) | .02 |
| C-reactive protein level, mg/L‡ | 11.1 (9.41-12.78) | 9.9 (8.35-11.40) | 15.0 (9.87-20.19) | .12 |
| β-2 Microglobulin level, μg/mL‡ | 5.2 (4.82-5.63) | 5.2 (4.70-5.65) | 5.4 (4.64-6.15) | .13 |
| Prior lines, n‡ | 2.0 (1.88-2.04) | 1.9 (1.84-2.01) | 2.1 (1.89-2.24) | .25 |
| Age at randomization, y‡ | 61.0 (60.26-61.77) | 60.8 (59.96-61.65) | 61.7 (60.05-63.38) | .32 |
| Male, %† | 58.1 | 57.8 | 59.0 | .85 |
| IgG, %† | 57.9 | 56.7 | 61.5 | .31 |
| Plasma cells in bone marrow aspirate, %‡ | 31.2 (28.9-33.4) | 28.4 (25.9-30.9) | 39.6 (35.0-44.2) | .001 |
| Trial 040 | ||||
| Overall survival, d* | 355.0 (277.0-434.0) | 349.0 (216.0-464.0) | 377.0 (336.0-486.0) | .76 |
| Time to progression, d* | 161.0 (137.0-203.0) | 168.0 (140.0-234.0) | 158.0 (119.0-204.0) | .19 |
| Response rate, CR + PR, %† | 29.1 | 25.3 | 42.9 | .02 |
| Response rate, CR + PR + MR, %† | 37.7 | 32.2 | 57.1 | .002 |
| Albumin level, g/L‡ | 35.9 (35.13-36.67) | 35.9 (35.02-36.73) | 36.0 (34.23-37.69) | .69 |
| Platelet count, × 109/L‡ | 150.6 (137.55-163.57) | 154.7 (139.42-169.99) | 137.8 (112.63-162.89) | .30 |
| C-reactive protein level, mg/L‖ | NA | NA | NA | |
| β-2 Microglobulin level, μg/mL‖ | NA | NA | NA | |
| Prior lines, n‖ | > 3 (4.00-4.00) | > 3 (4.00-4.00) | > 3 (4.00-4.00) | > .999 |
| Age at randomization, y‡ | 58.2 (56.89-59.41) | 58.5 (57.04-60.00) | 57.0 (54.62-59.45) | .33 |
| Male, %† | 61.5 | 62.6 | 57.9 | .53 |
| IgG, %† | 57.1 | 59.8 | 49.1 | .17 |
| Plasma cells in bone marrow aspirate, %‡ | 44.1 (39.0-49.2) | 37.9 (31.9-43.8) | 62.5 (54.1-70.9) | .001 |
| Variable . | Overall . | Nongenomics . | Genomics . | P, genomics vs nongenomics . |
|---|---|---|---|---|
| Trial 025 | ||||
| Overall survival, d* | 518.0 (434.0-643.0) | 533.0 (441.0-787.0) | 434.0 (237.0-628.0) | .06 |
| Time to progression, d* | 158.0 (119.0-213.0) | 210.0 (154.0-377.0) | 83.0 (60.0-139.0) | .03 |
| Response rate, CR + PR, %† | 30.1 | 30.0 | 30.2 | > .999 |
| Response rate, CR + PR + MR, %† | 40.4 | 40.7 | 39.5 | > .999 |
| Albumin level, g/L‡ | 35.2 (34.43-36.01) | 35.8 (34.87-36.64) | 33.4 (31.62-35.07) | .01 |
| Platelet count, × 109/L‡ | 170.5 (157.11-183.84) | 170.7 (155.22-186.27) | 169.5 (142.72-196.28) | .91 |
| C-reactive protein level, mg/L‡ | 13.0 (10.56-15.43) | 12.0 (9.45-14.45) | 16.5 (9.85-23.11) | .32 |
| β-2 Microglobulin level, μg/mL‡ | 5.6 (3.97-7.16) | 4.9 (3.91-5.91) | 7.8 (1.57-14.01) | .63 |
| Prior lines, n‡ | 4.5 (4.27-4.81) | 4.5 (4.24-4.82) | 4.6 (3.90-5.24) | .71 |
| Age at randomization, y‡ | 60.2 (58.87-61.45) | 60.5 (59.05-61.97) | 58.9 (56.03-61.74) | .47 |
| Male, %† | 60.5 | 59.1 | 65.9 | .49 |
| IgG, %† | 47.9 | 46.8 | 52.3 | .61 |
| Plasma cells in bone marrow aspirate, %‡ | 35.7 (30.9-40.5) | 30.0 (24.8-35.1) | 53.8 (43.9-63.7) | .001 |
| Trial 039§ | ||||
| Overall survival, d* | 773.0 (692.0-912.0) | 836.0 (694.0-NA) | 685.0 (565.0-NA) | .25 |
| Time to progression, d* | 147.0 (126.0-168.0) | 148.0 (127.0-170.0) | 127.0 (97.0-171.0) | .46 |
| Response rate, CR + PR, %† | 28.2 | 27.2 | 31.7 | .29 |
| Response rate, CR + PR + MR, %† | 40.5 | 39.6 | 43.4 | .44 |
| Albumin level, g/L‡ | 38.6 (38.16-39.04) | 38.8 (38.30-39.22) | 38.1 (36.97-39.17) | .43 |
| Platelet count, × 109/L‡ | 193.8 (187.61-200.00) | 197.9 (190.85-204.99) | 180.4 (167.63-193.14) | .02 |
| C-reactive protein level, mg/L‡ | 11.1 (9.41-12.78) | 9.9 (8.35-11.40) | 15.0 (9.87-20.19) | .12 |
| β-2 Microglobulin level, μg/mL‡ | 5.2 (4.82-5.63) | 5.2 (4.70-5.65) | 5.4 (4.64-6.15) | .13 |
| Prior lines, n‡ | 2.0 (1.88-2.04) | 1.9 (1.84-2.01) | 2.1 (1.89-2.24) | .25 |
| Age at randomization, y‡ | 61.0 (60.26-61.77) | 60.8 (59.96-61.65) | 61.7 (60.05-63.38) | .32 |
| Male, %† | 58.1 | 57.8 | 59.0 | .85 |
| IgG, %† | 57.9 | 56.7 | 61.5 | .31 |
| Plasma cells in bone marrow aspirate, %‡ | 31.2 (28.9-33.4) | 28.4 (25.9-30.9) | 39.6 (35.0-44.2) | .001 |
| Trial 040 | ||||
| Overall survival, d* | 355.0 (277.0-434.0) | 349.0 (216.0-464.0) | 377.0 (336.0-486.0) | .76 |
| Time to progression, d* | 161.0 (137.0-203.0) | 168.0 (140.0-234.0) | 158.0 (119.0-204.0) | .19 |
| Response rate, CR + PR, %† | 29.1 | 25.3 | 42.9 | .02 |
| Response rate, CR + PR + MR, %† | 37.7 | 32.2 | 57.1 | .002 |
| Albumin level, g/L‡ | 35.9 (35.13-36.67) | 35.9 (35.02-36.73) | 36.0 (34.23-37.69) | .69 |
| Platelet count, × 109/L‡ | 150.6 (137.55-163.57) | 154.7 (139.42-169.99) | 137.8 (112.63-162.89) | .30 |
| C-reactive protein level, mg/L‖ | NA | NA | NA | |
| β-2 Microglobulin level, μg/mL‖ | NA | NA | NA | |
| Prior lines, n‖ | > 3 (4.00-4.00) | > 3 (4.00-4.00) | > 3 (4.00-4.00) | > .999 |
| Age at randomization, y‡ | 58.2 (56.89-59.41) | 58.5 (57.04-60.00) | 57.0 (54.62-59.45) | .33 |
| Male, %† | 61.5 | 62.6 | 57.9 | .53 |
| IgG, %† | 57.1 | 59.8 | 49.1 | .17 |
| Plasma cells in bone marrow aspirate, %‡ | 44.1 (39.0-49.2) | 37.9 (31.9-43.8) | 62.5 (54.1-70.9) | .001 |
To convert β-2 microglobulin level from micrograms per milliliter to nanomoles per liter, multiply micrograms per milligrams by 85.
CR indicates complete response; PR, partial response; MR, minimal response; NA, not available; IgG, immunoglobulin G myeloma subtype.
Median time to event; 95% CI in parentheses; P value from log-rank test.
P value from Fisher exact test.
Mean; 95% CI in parentheses; P value from Wilcoxon rank sum test.
Data for patients receiving bortezomib or Dex.
No more detailed information collected.