Baseline characteristics
| . | 2 mg (N = 35) . | 4 mg (N = 35) . |
|---|---|---|
| Median age, y (range) | 62.0 (39.0-77.0) | 61.0 (45.0-77.0) |
| Sex | ||
| Female | 8 (22.9%) | 14 (40%) |
| Male | 27 (77.1%) | 21 (60%) |
| ECOG performance score | ||
| 0 | 13 (37.1%) | 13 (37.1%) |
| 1 | 18 (51.4%) | 18 (51.4%) |
| 2 | 4 (11.4%) | 4 (11.4%) |
| Median time from diagnosis to on study, mo (range) | 57.0 (11.7-248.5) | 71.6 (13.3-206.3) |
| Cytogenetics result | ||
| Normal | 15 (44.1%) | 12 (36.4%) |
| Abnormal | 13 (38.2%) | 17 (51.5%) |
| Not done | 6 (17.6%) | 4 (12.1%) |
| FISH | ||
| Normal | 0 | 1 (3.1%) |
| Abnormal | 25 (73.5%) | 26 (81.3%) |
| Not done | 9 (26.5%) | 5 (15.6%) |
| FISH results* | ||
| 13q− | 3 (9%) | 4 (13%) |
| Del 17, 17p− | 5 (15%) | 7 (23%) |
| t(11,14) | 7 (21%) | 6 (19%) |
| t(4;14) | 3 (9%) | 6 (19%) |
| t(14;16) | 0 (0%) | 2 (6%) |
| Other | 20 (59%) | 21 (68%) |
| High risk | 15 (55.6%) | 21 (60%) |
| ISS stage at diagnosis | ||
| 1 | 6 (17.1%) | 10 (28.6%) |
| 2 | 18 (51.4%) | 17 (48.6%) |
| 3 | 11 (31.4%) | 8 (22.9%) |
| Neuropathy at baseline | ||
| Grade 0 | 6 (17%) | 11 (32%) |
| Grade 1 | 24 (69%) | 19 (54%) |
| Grade 2 | 5 (14%) | 5 (14%) |
| ANC, K/μL | 2.2 (1.1-8.7) | 2.5 (1.1-6.9) |
| PLT, K/μL | 106.0 (77.0-279.0) | 134.0 (70.0-9200.0) |
| HGB, g/dL | 10.0 (8.2-14.4) | 10.6 (7.6-14.2) |
| WBC, K/μL | 3.8 (1.7-10.6) | 3.9 (1.8-8.8) |
| Creatinine, mg/dL | 1.0 (0.8-2.2) | 1.0 (0.6-2.0) |
| β2 microglobulin, μg/mL | 4.0 (1.9-9.6) | 3.5 (2.2-13.4) |
| CRP, mg/dL | 3.3 (0.2-335.3) | 6.3 (0.6-53.1) |
| BM labeling, % | 2.6 (0.0-10.2) | 1.8 (0.0-12.0) |
| . | 2 mg (N = 35) . | 4 mg (N = 35) . |
|---|---|---|
| Median age, y (range) | 62.0 (39.0-77.0) | 61.0 (45.0-77.0) |
| Sex | ||
| Female | 8 (22.9%) | 14 (40%) |
| Male | 27 (77.1%) | 21 (60%) |
| ECOG performance score | ||
| 0 | 13 (37.1%) | 13 (37.1%) |
| 1 | 18 (51.4%) | 18 (51.4%) |
| 2 | 4 (11.4%) | 4 (11.4%) |
| Median time from diagnosis to on study, mo (range) | 57.0 (11.7-248.5) | 71.6 (13.3-206.3) |
| Cytogenetics result | ||
| Normal | 15 (44.1%) | 12 (36.4%) |
| Abnormal | 13 (38.2%) | 17 (51.5%) |
| Not done | 6 (17.6%) | 4 (12.1%) |
| FISH | ||
| Normal | 0 | 1 (3.1%) |
| Abnormal | 25 (73.5%) | 26 (81.3%) |
| Not done | 9 (26.5%) | 5 (15.6%) |
| FISH results* | ||
| 13q− | 3 (9%) | 4 (13%) |
| Del 17, 17p− | 5 (15%) | 7 (23%) |
| t(11,14) | 7 (21%) | 6 (19%) |
| t(4;14) | 3 (9%) | 6 (19%) |
| t(14;16) | 0 (0%) | 2 (6%) |
| Other | 20 (59%) | 21 (68%) |
| High risk | 15 (55.6%) | 21 (60%) |
| ISS stage at diagnosis | ||
| 1 | 6 (17.1%) | 10 (28.6%) |
| 2 | 18 (51.4%) | 17 (48.6%) |
| 3 | 11 (31.4%) | 8 (22.9%) |
| Neuropathy at baseline | ||
| Grade 0 | 6 (17%) | 11 (32%) |
| Grade 1 | 24 (69%) | 19 (54%) |
| Grade 2 | 5 (14%) | 5 (14%) |
| ANC, K/μL | 2.2 (1.1-8.7) | 2.5 (1.1-6.9) |
| PLT, K/μL | 106.0 (77.0-279.0) | 134.0 (70.0-9200.0) |
| HGB, g/dL | 10.0 (8.2-14.4) | 10.6 (7.6-14.2) |
| WBC, K/μL | 3.8 (1.7-10.6) | 3.9 (1.8-8.8) |
| Creatinine, mg/dL | 1.0 (0.8-2.2) | 1.0 (0.6-2.0) |
| β2 microglobulin, μg/mL | 4.0 (1.9-9.6) | 3.5 (2.2-13.4) |
| CRP, mg/dL | 3.3 (0.2-335.3) | 6.3 (0.6-53.1) |
| BM labeling, % | 2.6 (0.0-10.2) | 1.8 (0.0-12.0) |
ECOG indicates Eastern Cooperative Oncology Group; ISS, international staging system; ANC, absolute neutrophil count; PLT, platelet; HGB, hemoglobulin; WBC, white blood count; and CRP, c-reactive protein.
FISH probes and locus for interphase cIg FISH: 3cen (D3Z1), 7cen (D7Z1), 9cen (D9Z1), 15cen (D15Z4), 11q13 (CCND1-XT), 14q32 (IGH-XT), 13q14 (RB1), 13q34 (LAMP1), 14q32 (5′IGH,3′IGH), 17p13.1 (p53), 17cen (D17Z1).