Table 1.
Demographic and baseline disease characteristics and prior therapies
| Phase 1 dose escalation (all doses) (N=31) |
Phase 2- Filanesib (N=32) |
Phase 2- Filanesib/Dex (N=55) |
|
|---|---|---|---|
| Male, n(%) | 20 (65) | 18 (56) | 27 (49) |
| White, n(%) | 24 (77) | 25 (78) | 39 (71) |
| Median age, years (range) | 60 (43, 79) | 65 (51, 82) | 63 (33, 82) |
| Heavy chain at diagnosis, n(%) | |||
| IgA | 7 (23) | 11 (34) | 14 (25) |
| IgD | 2 (6) | 0 (0) | 1 (2) |
| IgG | 17 (55) | 18 (56) | 28 (51) |
| IgM | 0 (0) | 1 (3) | 0 (0) |
| None | 5 (16) | 2 (6) | 12 (22) |
| Light chain at diagnosis, n(%) | |||
| Kappa | 22 (71) | 22 (69) | 38 (69) |
| Lambda | 8 (26) | 10 (31) | 17 (31) |
| Both or none | 1 (3) | 0 (0) | 0 (0) |
| Oligo- or non-secretory disease at diagnosis, n(%) | 1 (3) | 0 (0) | 0 (0) |
| ECOG status, n(%) | |||
| 0 | 6 (19) | 5 (16) | 6 (11) |
| 1 | 25 (81) | 26 (81) | 49 (89) |
| 2 | 0 (0) | 1 (3) | 0 (0) |
| ISS stage at study baseline, n(%) | |||
| I | 17 (55) | 10 (31) | 16 (29) |
| II | 12 (39) | 13 (41) | 22 (40) |
| III | 1 (3) | 9 (28) | 16 (29) |
| Missing | 1 (3) | 0 (0) | 1 (2) |
| High-risk cytogenetics at baseline, n(%)* | |||
| Yes | 0 (0) | 3 (9) | 17 (31) |
| No | 21 (68) | 25 (78) | 36 (65) |
| Missing | 10 (32) | 4 (12) | 2 (4) |
| Prior therapies, median (range) | 6 (2, 16) | 6 (2, 19) | 8 (2, 22) |
| Prior stem cell transplant, n(%) | 24 (77) | 26 (81) | 49 (89) |
| Prior carfilzomib, n(%) | 4 (13) | 2 (6) | 14 (25) |
| Prior pomalidomide, n(%) | 1 (3) | 1 (3) | 7 (13) |
| Prior bortezomib | |||
| Refractory† | 22 (71) | 18 (56) | 54 (98) |
| Relapsed | 8 (26) | 11 (34) | 1 (2) |
| Not applicable | 1 (3) | 3 (9) | 0 (0) |
| Prior dexamethasone | |||
| Refractory†,‡ | 23 (74) | 22 (69) | 54 (98) |
| Relapsed | 7 (23) | 10 (31) | 0 (0) |
| Not applicable | 1 (3) | 0 (0) | 1 (2) |
| Prior lenalidomide | |||
| Refractory† | 21 (68) | 25 (78) | 55 (100) |
| Relapsed | 8 (26) | 6 (19) | 0 (0) |
| Not applicable | 2 (6) | 1 (3) | 0 (0) |
*
Defined as one or more of the following: del(17p), t(4;14), t(14;16), 1q21 gain.
†
Documented progressive disease on therapy or within 60 days of completing treatment.
‡
The required dexamethasone dose was ≥ 40 mg per week on treatment weeks.
Abbreviations: Dex = dexamethasone; IgA = immunoglobulin A; IgD = immunoglobulin D; IgG = immunoglobulin G; IgM = immunoglobulin M; ECOG = Eastern Cooperative Oncology Group; ISS = International Staging System; n = number