Baseline demographics and disease characteristics by cohort and overall
| Characteristic . | Once-weekly bortezomib, cohort no.: dose (n) . | Twice-weekly bortezomib, cohort no.: dose (n) . | Total, N = 31 . | |||||
|---|---|---|---|---|---|---|---|---|
| 1: 0.7 mg/m2 (n = 3) . | 2: 1.0 mg/m2 (n = 3) . | 3: 1.3 mg/m2 (n = 3) . | 4: 1.6 mg/m2 (n = 6) . | 5: 0.7 mg/m2 (n = 3) . | 6: 1.0 mg/m2 (n = 6) . | 7: 1.3 mg/m2 (n = 7) . | ||
| Male sex, % | 2 | 1 | 2 | 3 | 3 | 2 | 6 | 19 (61) |
| White, % | 3 | 3 | 3 | 6 | 2 | 5 | 6 | 28 (90) |
| Median age, y (range) | 57 (38-63) | 65 (62-70) | 55 (53-69) | 60.5 (45-74) | 59 (53-76) | 54.5 (40-77) | 61 (47-71) | 59 (38-77) |
| Median KPS, % (range) | 90 (90-90) | 80 (80-80) | 80 (80-90) | 85 (80-100) | 90 (80-100) | 90 (80-100) | 90 (80-100) | 90 (80-100) |
| Median time from initial diagnosis, mo (range) | 85 (57-95) | 12 (10-32) | 20 (16-45) | 48.5 (14-85) | 38 (16-42) | 26.5 (15-70) | 23 (5-55) | 32 (5-95) |
| No. of organs involved, 1/2/3, n | 1/2/0 | 1/1/1 | 0/2/1 | 3/2/1 | 2/1/0 | 3/2/1 | 4/3/0 | 14 (45)/13 (42)/4(13) |
| Organ involvement*, n | ||||||||
| Renal | 2 | 2 | 1 | 1 | 1 | 4 | 3 | 14 (45) |
| Cardiac | 1 | — | 2 | 1 | — | 1 | 1 | 6 (19) |
| Hepatic | — | — | — | — | — | 1 | — | 1 (3) |
| Gastrointestinal | — | — | — | 2 | 2 | 1 | 2 | 7 (23) |
| Peripheral neuropathy | — | 1 | 2 | 1 | — | — | — | 4 (13) |
| Other† | 2 | 3 | 2 | 5 | 1 | 3 | 4 | 20 (65) |
| Amyloid involvement present in abdominal fat aspirate | 2 | 2 | 1 | 3 | 1 | 2 | 3 | 14 (45) |
| Other clinical evidence of organ involvement/other organ biopsy | 2 | 3 | 1 | 4 | — | 3 | 3 | 16 (52) |
| Grade 1 sensory neuropathy at baseline (%) | 1 | 1 | 1 | 2 | — | 3 | 3 | 11 (35) |
| History of grade 1 orthostatic hypotension (%) | — | 1 | — | — | — | 1 | — | 2 (6) |
| Median involved free light chain, mg/L | 35.30 | 174.50 | 121.00 | 94.20 | 39.60 | 77.90 | 43.30 | 66.35 |
| Median uninvolved free light chain, mg/L | 14.00 | 6.53 | 8.84 | 34.05 | 14.40 | 6.04 | 31.80 | 11.35 |
| Mean serum M-protein, g/dL | 1.83 | — | 0.06 | 3.80 | 3.25 | 1.18 | 0.63 | 1.77 |
| Mean urine M-protein, mg/24 h | — | 72.0 | — | 306.6 | 47.5 | 44.1 | 536.5 | 249.0 |
| Mean hemoglobin, g/L | 144.0 | 132.3 | 147.7 | 117.7 | 122.7 | 139.5 | 124.7 | 130.8 |
| Mean platelets, ×109/L | 352.7 | 313.7 | 261.0 | 284.7 | 182.7 | 320.7 | 248.0 | 280.6 |
| Mean creatinine clearance, mL/s (mL/min) | 1.88 (112.8) | 1.09 (65.4) | 0.6 (36.0)‡ | 1.51 (90.6) | 1.24 (74.4) | 1.14 (68.4) | 1.07 (64.2) | 1.24 (74.4) |
| Prior systemic therapy, n | 3 | 3 | 3 | 6 | 3 | 6 | 7 | 31 (100) |
| HDT-SCT | 2 | — | 2 | 4 | 1 | 2 | 2 | 13 (42) |
| Oral melphalan | 3 | 3 | 2 | 5 | 3 | 5 | 6 | 27 (87) |
| Thalidomide | 1 | 2 | 2 | 3 | — | 4 | 1 | 13 (42) |
| Dexamethasone | 2 | 3 | 2 | 5 | 3 | 6 | 5 | 26 (84) |
| Characteristic . | Once-weekly bortezomib, cohort no.: dose (n) . | Twice-weekly bortezomib, cohort no.: dose (n) . | Total, N = 31 . | |||||
|---|---|---|---|---|---|---|---|---|
| 1: 0.7 mg/m2 (n = 3) . | 2: 1.0 mg/m2 (n = 3) . | 3: 1.3 mg/m2 (n = 3) . | 4: 1.6 mg/m2 (n = 6) . | 5: 0.7 mg/m2 (n = 3) . | 6: 1.0 mg/m2 (n = 6) . | 7: 1.3 mg/m2 (n = 7) . | ||
| Male sex, % | 2 | 1 | 2 | 3 | 3 | 2 | 6 | 19 (61) |
| White, % | 3 | 3 | 3 | 6 | 2 | 5 | 6 | 28 (90) |
| Median age, y (range) | 57 (38-63) | 65 (62-70) | 55 (53-69) | 60.5 (45-74) | 59 (53-76) | 54.5 (40-77) | 61 (47-71) | 59 (38-77) |
| Median KPS, % (range) | 90 (90-90) | 80 (80-80) | 80 (80-90) | 85 (80-100) | 90 (80-100) | 90 (80-100) | 90 (80-100) | 90 (80-100) |
| Median time from initial diagnosis, mo (range) | 85 (57-95) | 12 (10-32) | 20 (16-45) | 48.5 (14-85) | 38 (16-42) | 26.5 (15-70) | 23 (5-55) | 32 (5-95) |
| No. of organs involved, 1/2/3, n | 1/2/0 | 1/1/1 | 0/2/1 | 3/2/1 | 2/1/0 | 3/2/1 | 4/3/0 | 14 (45)/13 (42)/4(13) |
| Organ involvement*, n | ||||||||
| Renal | 2 | 2 | 1 | 1 | 1 | 4 | 3 | 14 (45) |
| Cardiac | 1 | — | 2 | 1 | — | 1 | 1 | 6 (19) |
| Hepatic | — | — | — | — | — | 1 | — | 1 (3) |
| Gastrointestinal | — | — | — | 2 | 2 | 1 | 2 | 7 (23) |
| Peripheral neuropathy | — | 1 | 2 | 1 | — | — | — | 4 (13) |
| Other† | 2 | 3 | 2 | 5 | 1 | 3 | 4 | 20 (65) |
| Amyloid involvement present in abdominal fat aspirate | 2 | 2 | 1 | 3 | 1 | 2 | 3 | 14 (45) |
| Other clinical evidence of organ involvement/other organ biopsy | 2 | 3 | 1 | 4 | — | 3 | 3 | 16 (52) |
| Grade 1 sensory neuropathy at baseline (%) | 1 | 1 | 1 | 2 | — | 3 | 3 | 11 (35) |
| History of grade 1 orthostatic hypotension (%) | — | 1 | — | — | — | 1 | — | 2 (6) |
| Median involved free light chain, mg/L | 35.30 | 174.50 | 121.00 | 94.20 | 39.60 | 77.90 | 43.30 | 66.35 |
| Median uninvolved free light chain, mg/L | 14.00 | 6.53 | 8.84 | 34.05 | 14.40 | 6.04 | 31.80 | 11.35 |
| Mean serum M-protein, g/dL | 1.83 | — | 0.06 | 3.80 | 3.25 | 1.18 | 0.63 | 1.77 |
| Mean urine M-protein, mg/24 h | — | 72.0 | — | 306.6 | 47.5 | 44.1 | 536.5 | 249.0 |
| Mean hemoglobin, g/L | 144.0 | 132.3 | 147.7 | 117.7 | 122.7 | 139.5 | 124.7 | 130.8 |
| Mean platelets, ×109/L | 352.7 | 313.7 | 261.0 | 284.7 | 182.7 | 320.7 | 248.0 | 280.6 |
| Mean creatinine clearance, mL/s (mL/min) | 1.88 (112.8) | 1.09 (65.4) | 0.6 (36.0)‡ | 1.51 (90.6) | 1.24 (74.4) | 1.14 (68.4) | 1.07 (64.2) | 1.24 (74.4) |
| Prior systemic therapy, n | 3 | 3 | 3 | 6 | 3 | 6 | 7 | 31 (100) |
| HDT-SCT | 2 | — | 2 | 4 | 1 | 2 | 2 | 13 (42) |
| Oral melphalan | 3 | 3 | 2 | 5 | 3 | 5 | 6 | 27 (87) |
| Thalidomide | 1 | 2 | 2 | 3 | — | 4 | 1 | 13 (42) |
| Dexamethasone | 2 | 3 | 2 | 5 | 3 | 6 | 5 | 26 (84) |
Categories are not mutually exclusive; patients could be included in multiple categories, reflecting multiple organ involvement.
Among patients with “other” organ involvement, 7 (23%) had this recorded as their only organ involvement, including 1 patient each in cohorts 1, 2, 4, and 6, 2 patients in cohort 7 with both “amyloid involvement present in abdominal fat aspirate” and “other clinical evidence of organ involvement/other organ biopsy,” and 1 patient in cohort 6 with only “other clinical evidence of organ involvement/other organ biopsy.”
One patient had a pretreatment creatinine clearance of less than .6667 mL/s (40 mL/min), a protocol violation, but all postbaseline values were more than .8333 mL/s (50 mL/min).