Patient demographics and baseline characteristics
| Characteristic . | Cohort 1, 20 mg/m2 (n = 59) . | Cohort 2, 20/27 mg/m2 (n = 70) . | Total (N = 129) . |
|---|---|---|---|
| Median age, y (range) | 65 (38-82) | 66 (45-85) | 65 (38-85) |
| Male, n (%) | 32 (54.2) | 44 (62.9) | 76 (58.9) |
| Ethnicity, n (%) | |||
| White | 46 (78.0) | 52 (74.3) | 98 (76.0) |
| African American | 6 (10.2) | 12 (17.1) | 18 (14.0) |
| Asian/Pacific Islander | 2 (3.4) | 3 (4.3) | 5 (3.9) |
| Hispanic | 4 (6.8) | 2 (2.9) | 6 (4.7) |
| Other | 1 (1.7) | 1 (1.4) | 2 (1.6) |
| Median time from diagnosis, y (range) | 3.5 (0.7-24.4) | 3.6 (0.7-12.2) | 3.6 (0.7-24.4) |
| Ig subtype, n (%) | |||
| IgG | 32 (54.2) | 54 (77.1) | 86 (66.7) |
| IgA | 19 (32.2) | 14 (20.0) | 33 (25.6) |
| Not reported/missing | 8 (13.6) | 2 (2.9) | 10 (7.8) |
| Light-chain subtype, n (%) | |||
| Kappa | 44 (74.6) | 50 (71.4) | 94 (72.9) |
| Lambda | 15 (25.4) | 20 (28.6) | 35 (27.1) |
| ECOG performance status, n (%) | |||
| 0 | 29 (49.2) | 23 (32.9) | 52 (40.3) |
| 1 or 2 | 30 (50.8) | 47 (67.1) | 77 (59.7) |
| ISS stage, n (%) | |||
| I or II | 41 (69.5) | 53 (75.7) | 94 (72.9) |
| III | 6 (10.2) | 16 (22.9) | 22 (17.1) |
| Not reported/missing | 12 (20.3) | 1 (1.4) | 13 (10.1) |
| Baseline evaluations, n (%) | |||
| Neuropathy history* | 42 (71.2) | 48 (68.6) | 90 (69.8) |
| CrCl < 50 mL/min | 8 (13.6) | 12 (17.1) | 20 (15.5) |
| Cytogenetic/FISH prognostic markers, n (%) | |||
| Normal/favorable | 46 (78.0) | 57 (81.4) | 103 (79.8) |
| Poor | 9 (15.3) | 10 (14.3) | 19 (14.7) |
| Unknown or not done | 4 (6.8) | 3 (4.3) | 7 (5.4) |
| Characteristic . | Cohort 1, 20 mg/m2 (n = 59) . | Cohort 2, 20/27 mg/m2 (n = 70) . | Total (N = 129) . |
|---|---|---|---|
| Median age, y (range) | 65 (38-82) | 66 (45-85) | 65 (38-85) |
| Male, n (%) | 32 (54.2) | 44 (62.9) | 76 (58.9) |
| Ethnicity, n (%) | |||
| White | 46 (78.0) | 52 (74.3) | 98 (76.0) |
| African American | 6 (10.2) | 12 (17.1) | 18 (14.0) |
| Asian/Pacific Islander | 2 (3.4) | 3 (4.3) | 5 (3.9) |
| Hispanic | 4 (6.8) | 2 (2.9) | 6 (4.7) |
| Other | 1 (1.7) | 1 (1.4) | 2 (1.6) |
| Median time from diagnosis, y (range) | 3.5 (0.7-24.4) | 3.6 (0.7-12.2) | 3.6 (0.7-24.4) |
| Ig subtype, n (%) | |||
| IgG | 32 (54.2) | 54 (77.1) | 86 (66.7) |
| IgA | 19 (32.2) | 14 (20.0) | 33 (25.6) |
| Not reported/missing | 8 (13.6) | 2 (2.9) | 10 (7.8) |
| Light-chain subtype, n (%) | |||
| Kappa | 44 (74.6) | 50 (71.4) | 94 (72.9) |
| Lambda | 15 (25.4) | 20 (28.6) | 35 (27.1) |
| ECOG performance status, n (%) | |||
| 0 | 29 (49.2) | 23 (32.9) | 52 (40.3) |
| 1 or 2 | 30 (50.8) | 47 (67.1) | 77 (59.7) |
| ISS stage, n (%) | |||
| I or II | 41 (69.5) | 53 (75.7) | 94 (72.9) |
| III | 6 (10.2) | 16 (22.9) | 22 (17.1) |
| Not reported/missing | 12 (20.3) | 1 (1.4) | 13 (10.1) |
| Baseline evaluations, n (%) | |||
| Neuropathy history* | 42 (71.2) | 48 (68.6) | 90 (69.8) |
| CrCl < 50 mL/min | 8 (13.6) | 12 (17.1) | 20 (15.5) |
| Cytogenetic/FISH prognostic markers, n (%) | |||
| Normal/favorable | 46 (78.0) | 57 (81.4) | 103 (79.8) |
| Poor | 9 (15.3) | 10 (14.3) | 19 (14.7) |
| Unknown or not done | 4 (6.8) | 3 (4.3) | 7 (5.4) |
CrCl indicates creatinine clearance.
Baseline PN: Cohort 1, 29 (49.2); Cohort 2, 39 (55.7); Total, 68 (52.7).