Table 1.
Randomized patient characteristics by treatment arm allocation.
| Treatment arm | ||||
|---|---|---|---|---|
| Vaccine/GM-CSF/Lenalidomide (N = 68) N (%) | Lenalidomide/GM-CSF (N = 37) N (%) | Lenalidomide alone (N = 35) N (%) | Total (N = 140) N (%) | |
| Gender | ||||
| Female | 27 (39.7%) | 18 (48.6%) | 18 (51.4%) | 63 (45.0%) |
| Male | 41 (60.3%) | 19 (51.4%) | 17 (48.6%) | 77 (55.0%) |
| Age, y | ||||
| Median (range) | 60.2 (41.6–70.2) | 64.0 (44.2–70.2) | 59.2 (35.2–70.9) | 61.6 (35.2–70.9) |
| Black or African American | 8 (11.8%) | 2 (5.4%) | 5 (14.3%) | 27 (13.3%) |
| Karnofsky performance score | ||||
| 100 | 16 (23.5%) | 7 (18.9%) | 9 (25.7%) | 32 (22.9%) |
| 90 | 29 (42.6%) | 10 (27.0%) | 14 (40.0%) | 53 (37.9%) |
| 80 | 17 (25.0%) | 15 (40.5%) | 9 (25.7%) | 41 (29.3%) |
| 70 | 6 (8.8%) | 5 (13.5%) | 3 (8.6%) | 14 (10.0%) |
| Plasma cells percentage in BM aspirate differential | ||||
| Mean (SD) | 49.1 (23.5) | 48.9 (21.8) | 48.4 (20.2) | 48.9 (22.1) |
| Median (range) | 45 (9–100) | 40 (20–93) | 50 (20–80) | 45 (9–100) |
| Received initial systemic therapy prior to enrollment | ||||
| Yes | 7 (10.3%) | 4 (10.8%) | 3 (8.6%) | 14 (10.0%) |
| No | 61 (89.7%) | 33 (89.2%) | 32 (91.4%) | 126 (90.0%) |
| Randomization strata (1) | ||||
| sCR/CR | 24 (35.3%) | 14 (37.8%) | 13 (37.1%) | 51 (36.4%) |
| VGPR/PR/stable disease | 44 (64.7%) | 23 (62.2%) | 22 (62.9%) | 89 (63.6%) |
| Disease status at randomization (1) | ||||
| Stringent complete response | 11 (16.2%) | 6 (16.2%) | 4 (11.4%) | 21 (15.0%) |
| Complete response | 11 (16.2%) | 9 (24.3%) | 9 (25.7%) | 29 (20.7%) |
| Very good partial response | 37 (54.4%) | 15 (40.5%) | 17 (48.6%) | 69 (49.3%) |
| Partial response | 9 (13.2%) | 7 (18.9%) | 5 (14.3%) | 21 (15.0%) |
| Stable response | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Received initial systemic anti-myeloma therapy prior to randomization | ||||
| Yes | 65 (95.6%) | 35 (94.6%) | 32 (91.4%) | 132 (94.3%) |
| # Lines of systemic therapy received | ||||
| 1 | 49 (75.4%) | 28 (80.0%) | 21 (65.6%) | 98 (74.2%) |
| 2 | 11 (16.9%) | 5 (14.3%) | 7 (21.9%) | 23 (17.4%) |
| 3 | 5 (7.7%) | 1 (2.9%) | 3 (9.4%) | 9 (6.8%) |
| 4 | 0 (0.0%) | 1 (2.9%) | 1 (3.1%) | 2 (1.5%) |
| No | 3 (4.4%) | 2 (5.4%) | 3 (8.6%) | 8 (5.7%) |
| Unknown/missing | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Risk stratification | ||||
| Standard | 23 (33.8%) | 9 (24.3%) | 15 (42.9%) | 47 (33.6%) |
| High | 44 (64.7%) | 27 (73.0%) | 20 (57.1%) | 91 (65.0%) |
| Time from diagnosis date to enrollment, months | ||||
| Mean (SD) | 9.9 (6.9) | 11.2 (12.1) | 9.0 (1.7) | 10.0 (7.9) |
| Median (range) | 8 (6–53) | 8 (3–80) | 9 (7–13) | 8 (3–80) |
| Time from enrollment to transplant, months | ||||
| Mean (SD) | 5.5 (1.9) | 5.6 (1.8) | 5.6 (1.3) | 5.6 (1.7) |
| Median (range) | 5 (3–11) | 5 (4–11) | 5 (4–9) | 5 (3–11) |
| Time from transplant to randomization, days | ||||
| Mean (SD) | 66.3 (7.7) | 67.1 (9.4) | 67.7 (8.5) | 66.9 (8.3) |
| Median (range) | 68 (49–92) | 69 (50–79) | 67 (53–87) | 69 (49–92) |
| Time from randomization to maintenance initiation, days | ||||
| Mean (SD) | 30.1 (8.2) | 27.6 (9.7) | 27.8 (9.7) | 28.9 (9.0) |
| Median (range) | 30 (12–47) | 27 (12–47) | 27 (9–49) | 28 (9–49) |