Table 1.
Baseline demographics and disease characteristics.
| Intense (n = 41) | Intermediate (n = 41) | Short (n = 41) | |
|---|---|---|---|
| Median (range) age, years | 65.0 (34–79) | 62.0 (31–81) | 59.0 (39–78) |
| Female, n (%) | 24 (58.5) | 24 (58.5) | 20 (48.8) |
| Race, n (%) | |||
| White | 35 (85.4) | 37 (90.2) | 35 (85.4) |
| Black or African American | 2 (4.9) | 1 (2.4) | 2 (4.9) |
| Asian | 2 (4.9) | 1 (2.4) | 1 (2.4) |
| Other | 2 (4.9) | 2 (4.9) | 3 (7.3) |
| ECOG performance status score, n (%) | |||
| 0 | 32 (78.0) | 34 (82.9) | 35 (85.4) |
| 1 | 9 (22.0) | 7 (17.1) | 6 (14.6) |
| Risk factors at screening,a n (%) | |||
| <2 | 8 (19.5) | 8 (19.5) | 7 (17.1) |
| ≥2 | 33 (80.5) | 33 (80.5) | 34 (82.9) |
| Type of disease, n (%) | |||
| IgG | 33 (80.5) | 30 (73.2) | 27 (65.9) |
| IgA | 6 (14.6) | 7 (17.1) | 9 (22.0) |
| Others | 2 (4.9) | 4 (9.8) | 5 (12.2) |
| % plasma cells in bone marrow, n (%) | |||
| ≥10% to <20% | 18 (43.9) | 17 (41.5) | 21 (51.2) |
| ≥20% to <40% | 15 (36.6) | 17 (41.5) | 13 (31.7) |
| ≥40% to <60% | 8 (19.5) | 7 (17.1) | 7 (17.1) |
| Cytogenetic abnormalities,b n (%) | |||
| nc | 37 | 35 | 33 |
| t(4;14) | 2 (5.4) | 3 (8.6) | 0 |
| t(14;16) | 0 | 0 | 0 |
| del(17p) | 2 (5.4) | 3 (8.6) | 1 (3.0) |
| del(13q) | 6 (16.2) | 7 (20.0) | 4 (12.1) |
| Gain or amp 1q21 | 7 (18.9) | 6 (17.1) | 8 (24.2) |
| Median (range) time from SMM diagnosis to randomization, months | 6.47 (0.4–46.2) | 5.52 (0.7–46.7) | 7.43 (1.0–56.0) |
ECOG Eastern Cooperative Oncology Group, SMM smoldering multiple myeloma.
aRisk factors include abnormal free light chain ratio (<0.126 or >8), serum M-protein ≥3 g/dl, urine M-protein >500 mg/24 h, IgA subtype, and immunoparesis (at least one uninvolved immunoglobulin [IgG, IgA, IgM] decreased >25% below the lower limit of normal) [20].
bCytogenetic abnormalities were detected by FISH and/or karyotyping.
cIncludes all patients with available cytogenetics data. Among the 105 patients with available cytogenetics data, cytogenetic risk was assessed by karyotyping alone in 13 patients, by FISH alone in 50 patients, and by both karyotyping and FISH in 42 patients.