Baseline demographics and disease characteristics
| Characteristic . | All treated patients, N = 66 . | Phase 2 population, n = 35 . |
|---|---|---|
| Median age, y (range) | 58 (22-86) | 59 (22-86) |
| Male sex, n (%) | 36 (55) | 19 (54) |
| Race, n (%) | ||
| White | 53 (80) | 27 (77) |
| Black | 11 (17) | 7 (20) |
| Other | 2 (3) | 1 (3) |
| ECOG performance status, n (%) | ||
| 0 | 43 (65) | 17 (49) |
| 1 | 17 (26) | 13 (37) |
| 2 | 6 (9) | 5 (14) |
| ISS stage at treatment initiation, n (%) | ||
| I | 29 (44) | 12 (34) |
| II | 31 (47) | 19 (54) |
| III | 6 (9) | 4 (11) |
| Durie-Salmon stage at diagnosis, n (%)* | ||
| I | 22 (33) | 9 (26) |
| II | 21 (32) | 13 (37) |
| III | 23 (35) | 13 (37) |
| MM subtype, n (%) | ||
| IgG | 45 (68) | 20 (57) |
| IgA | 15 (23) | 11 (31) |
| Light chain | 6 (9) | 4 (11) |
| β2-microglobulin level, n (%) | ||
| < 3.5 mg/L | 44 (67) | 19 (54) |
| 3.5-5.5 mg/L | 17 (26) | 13 (37) |
| > 5.5 mg/L | 5 (8) | 3 (9) |
| Albumin level, n (%) | ||
| < 3.5 g/dL | 24 (36) | 17 (49) |
| ≥ 3.5 g/dL | 42 (64) | 18 (51) |
| Elevated LDH, n (%) | 6 (9) | 4 (11) |
| Lytic lesions, n (%)† | ||
| None | 16 (24) | 5 (14) |
| 1-3 bones | 15 (23) | 10 (29) |
| > 3 bones | 34 (52) | 19 (54) |
| Abnormal metaphase cytogenetics, n (%) | 6 (9) | 2 (6) |
| FISH abnormalities,‡n (%) | ||
| Del 13q | 24 (47) | 16 (53) |
| Del 17p | 5 (10) | 2 (7) |
| t(4;14) | 2 (5) | 2 (9) |
| t(11;14) | 11 (22) | 7 (23) |
| Del 17p and/or t(4;14) | 6 (12) | 3 (8) |
| Characteristic . | All treated patients, N = 66 . | Phase 2 population, n = 35 . |
|---|---|---|
| Median age, y (range) | 58 (22-86) | 59 (22-86) |
| Male sex, n (%) | 36 (55) | 19 (54) |
| Race, n (%) | ||
| White | 53 (80) | 27 (77) |
| Black | 11 (17) | 7 (20) |
| Other | 2 (3) | 1 (3) |
| ECOG performance status, n (%) | ||
| 0 | 43 (65) | 17 (49) |
| 1 | 17 (26) | 13 (37) |
| 2 | 6 (9) | 5 (14) |
| ISS stage at treatment initiation, n (%) | ||
| I | 29 (44) | 12 (34) |
| II | 31 (47) | 19 (54) |
| III | 6 (9) | 4 (11) |
| Durie-Salmon stage at diagnosis, n (%)* | ||
| I | 22 (33) | 9 (26) |
| II | 21 (32) | 13 (37) |
| III | 23 (35) | 13 (37) |
| MM subtype, n (%) | ||
| IgG | 45 (68) | 20 (57) |
| IgA | 15 (23) | 11 (31) |
| Light chain | 6 (9) | 4 (11) |
| β2-microglobulin level, n (%) | ||
| < 3.5 mg/L | 44 (67) | 19 (54) |
| 3.5-5.5 mg/L | 17 (26) | 13 (37) |
| > 5.5 mg/L | 5 (8) | 3 (9) |
| Albumin level, n (%) | ||
| < 3.5 g/dL | 24 (36) | 17 (49) |
| ≥ 3.5 g/dL | 42 (64) | 18 (51) |
| Elevated LDH, n (%) | 6 (9) | 4 (11) |
| Lytic lesions, n (%)† | ||
| None | 16 (24) | 5 (14) |
| 1-3 bones | 15 (23) | 10 (29) |
| > 3 bones | 34 (52) | 19 (54) |
| Abnormal metaphase cytogenetics, n (%) | 6 (9) | 2 (6) |
| FISH abnormalities,‡n (%) | ||
| Del 13q | 24 (47) | 16 (53) |
| Del 17p | 5 (10) | 2 (7) |
| t(4;14) | 2 (5) | 2 (9) |
| t(11;14) | 11 (22) | 7 (23) |
| Del 17p and/or t(4;14) | 6 (12) | 3 (8) |
ECOG indicates Eastern Cooperative Oncology Group; FISH, fluorescence in situ hybridization; IgA, immunoglobulin A; IgG, immunoglobulin G; ISS, International Staging System; LDH, lactate dehydrogenase; and MM, multiple myeloma.
All patients were symptomatic at enrollment/treatment initiation.
Data missing for 1 patient in the phase 2 population.
Numbers of patients with results for del 13q, del 17p, t(4;14), and t(11;14) status were 51, 50, 41, and 51, respectively, for the overall population, and 30, 30, 22, and 30 for the phase 2 population. N values for analyses of “Del 17p and/or t(4;14)” were 50 for the overall population and 36 for the phase 2 population. A patient was determined to have abnormal cytogenetics if, when FISH was used, the percentage of nuclei consistent with these cytogenetic abnormalities exceeded the normal ranges established for the respective probes in the cytogenetics laboratory of each participating institution.