Demographics and baseline characteristics of patients enrolled to the dose-escalation cohorts and the expansion cohorts
| Characteristic . | Dose-escalation cohorts (n = 32) . | Expansion cohorts (n = 31*) . | Total (N = 60) . |
|---|---|---|---|
| Median age, y (range) | 64.0 (40-76) | 65.0 (40-79) | 64.0 (40-79) |
| Male, n (%) | 17 (53) | 18 (58) | 33 (55) |
| Race, n (%) | |||
| White | 25 (78) | 29 (94) | 51 (85) |
| African American | 7 (22) | 0 | 7 (12) |
| Other | 0 | 2 (6) | 2 (3) |
| MM subtype, n (%) | |||
| IgG | 18 (56) | 24 (77) | 41 (68) |
| IgA | 9 (28) | 3 (10) | 10 (17) |
| Light chain | 5 (16) | 4 (13) | 9 (15) |
| ISS disease stage, n (%) | |||
| I | 13 (41) | 5 (16) | 18 (30) |
| II | 13 (41) | 18 (58) | 29 (48) |
| III | 5 (16) | 7 (23) | 12 (20) |
| Unknown | 1 (3) | 1 (3) | 1 (3) |
| Median β2-microglobulin, mg/L (range) | 3.80 (1.6-11.3) | 4.15 (1.8-8.0) | 3.80 (1.6-11.3) |
| Median creatinine clearance, mL/min (range) | 74.46 (30.8-179.5) | 78.75 (26.0-214.5) | 76.55 (26.0-214.5) |
| Creatinine clearance <50 mL/min, n (%)† | 3 (9) | 7 (23) | 10 (17) |
| Patients with cytogenetic assessment, n | 30 | 28 | 55 |
| Cytogenetics by FISH, n/N (%) | 24/30 (80) | 23/28 (82) | 44/55 (80) |
| Unfavorable cytogenetic abnormalities, n (%) | |||
| t(4;14) | 2 (8) | 3 (13) | 4 (9) |
| t(14;16) | 0 | 1 (4) | 1 (2) |
| −17p | 2 (8) | 1 (4) | 3 (7) |
| Median time since MM diagnosis, years (range) | 4.9 (1.5-18.8) | 4.9 (1.7-12.3) | 4.9 (1.5-18.8) |
| Median number of prior lines of therapy, n (range) | 4 (1‡-13) | 3 (1-12) | 4 (1-13) |
| Prior therapy with: n (%) | |||
| Bortezomib | 31 (97)‡ | 23 (74) | 51 (85) |
| Lenalidomide | 30 (94) | 31 (100) | 58 (97) |
| Thalidomide | 19 (59) | 15 (48) | 32 (53) |
| Carfilzomib | 4 (13) | 5 (16) | 9 (15) |
| Prior SCT, n (%) | 23 (72) | 25 (81) | 46 (77) |
| Refractory to last prior therapy, n (%) | 17 (57)§ | 27 (87) | 42 (72)§ |
| Bortezomib-refractory, n (%) | 7 (22) | 5 (16) | 11 (18) |
| Lenalidomide/thalidomide-refractory, n (%) | 11 (34) | 13 (42) | 23 (38) |
| Characteristic . | Dose-escalation cohorts (n = 32) . | Expansion cohorts (n = 31*) . | Total (N = 60) . |
|---|---|---|---|
| Median age, y (range) | 64.0 (40-76) | 65.0 (40-79) | 64.0 (40-79) |
| Male, n (%) | 17 (53) | 18 (58) | 33 (55) |
| Race, n (%) | |||
| White | 25 (78) | 29 (94) | 51 (85) |
| African American | 7 (22) | 0 | 7 (12) |
| Other | 0 | 2 (6) | 2 (3) |
| MM subtype, n (%) | |||
| IgG | 18 (56) | 24 (77) | 41 (68) |
| IgA | 9 (28) | 3 (10) | 10 (17) |
| Light chain | 5 (16) | 4 (13) | 9 (15) |
| ISS disease stage, n (%) | |||
| I | 13 (41) | 5 (16) | 18 (30) |
| II | 13 (41) | 18 (58) | 29 (48) |
| III | 5 (16) | 7 (23) | 12 (20) |
| Unknown | 1 (3) | 1 (3) | 1 (3) |
| Median β2-microglobulin, mg/L (range) | 3.80 (1.6-11.3) | 4.15 (1.8-8.0) | 3.80 (1.6-11.3) |
| Median creatinine clearance, mL/min (range) | 74.46 (30.8-179.5) | 78.75 (26.0-214.5) | 76.55 (26.0-214.5) |
| Creatinine clearance <50 mL/min, n (%)† | 3 (9) | 7 (23) | 10 (17) |
| Patients with cytogenetic assessment, n | 30 | 28 | 55 |
| Cytogenetics by FISH, n/N (%) | 24/30 (80) | 23/28 (82) | 44/55 (80) |
| Unfavorable cytogenetic abnormalities, n (%) | |||
| t(4;14) | 2 (8) | 3 (13) | 4 (9) |
| t(14;16) | 0 | 1 (4) | 1 (2) |
| −17p | 2 (8) | 1 (4) | 3 (7) |
| Median time since MM diagnosis, years (range) | 4.9 (1.5-18.8) | 4.9 (1.7-12.3) | 4.9 (1.5-18.8) |
| Median number of prior lines of therapy, n (range) | 4 (1‡-13) | 3 (1-12) | 4 (1-13) |
| Prior therapy with: n (%) | |||
| Bortezomib | 31 (97)‡ | 23 (74) | 51 (85) |
| Lenalidomide | 30 (94) | 31 (100) | 58 (97) |
| Thalidomide | 19 (59) | 15 (48) | 32 (53) |
| Carfilzomib | 4 (13) | 5 (16) | 9 (15) |
| Prior SCT, n (%) | 23 (72) | 25 (81) | 46 (77) |
| Refractory to last prior therapy, n (%) | 17 (57)§ | 27 (87) | 42 (72)§ |
| Bortezomib-refractory, n (%) | 7 (22) | 5 (16) | 11 (18) |
| Lenalidomide/thalidomide-refractory, n (%) | 11 (34) | 13 (42) | 23 (38) |