TABLE 1.
Demographic and Baseline Disease Characteristics and Prior Therapies (All Patients)
| Characteristic | Dose-Escalation Phase Total N = 55 |
|---|---|
| Sex | |
| Male, no. (%) | 30 (55) |
| Female, no. (%) | 25 (45) |
| Race, no. (%) | |
| White | 36 (65) |
| Black/African American | 14 (25) |
| Other | 5 (9) |
| Median age (range), y | 63 (31–79) |
| Median y since diagnosis (range) | 5.1 (1.5–12.0) |
| Ig subtype at diagnosis, no. (%) | |
| IgG | 34 (62) |
| IgA | 9 (16) |
| IgM | 1 (2) |
| Light chain only | 11 (20) |
| Light chain at diagnosis, no. (%) | |
| Kappa | 34 (62) |
| Lambda | 21 (38) |
| ISS stage at diagnosis, no. (%) | |
| I | 9 (16) |
| II | 16 (29) |
| III | 12 (22) |
| Missing | 18 (33) |
| ECOG performance status, no. (%) | |
| 0 | 19 (35) |
| 1 | 36 (65) |
| Creatinine clearance, mL/minute | |
| >90 | 24 (44) |
| 60–89 | 17 (31) |
| 30–59 | 13 (24) |
| 15–29 | 1 (2) |
| High-risk cytogenetics, no. (%)a | |
| Yes | 12 (22) |
| No | 41 (75) |
| Missing/unknown | 2 (4) |
| Prior lines of therapy, median (range) | 3 (1–9) |
| Prior proteasome inhibitor | 55 (100) |
| Recurrent | 23 (42) |
| Refractory | 31 (56) |
| Unknown | 1 (2) |
| Prior bortezomib | 52 (95) |
| Recurrent | 23 (42) |
| Refractory | 28 (51) |
| Unknown | 1 (2) |
| Prior carfilzomib | 9 (16) |
| Refractory | 9 (16) |
| Prior IMiD | 55 (100) |
| Recurrent | 12 (22) |
| Refractory | 42 (76) |
| Prior lenalidomide | 54 (98) |
| Recurrent | 12 (22) |
| Refractory | 41 (75) |
| Unknown | 1 (2) |
| Prior pomalidomide | 7 (13) |
| Refractory | 7 (13) |
| Prior corticosteroid | 55 (100) |
| Prior alkylator | 51 (93) |
| Prior stem cell transplantation | 49 (89) |
| Prior anthracycline | 22 (40) |
Abbreviations: ECOG, Eastern Cooperative Oncology Group; Ig, immunoglobulin; IMiD, immunomodulatory agent; ISS, International Staging System.
a
Defined as ≥1of the following: del(17p), t(14;16), or 1q21 gain.