Table 1.
Patient baseline characteristics and disposition (Part 1 and Part 2)
| Part 1 | Part 2 | |
|---|---|---|
| Characteristic | n=38 | n=35 |
| Age, median (range), years | 60 (39–79) | 60 (46–75) |
| Sex, male / female, n (%) | 20 (53) / 18 (47) | 17 (49) / 18 (51) |
| Disease stage at diagnosis*I / II / III / unknown, % | 7 (18) /6 (16) / 8 (21) / 17 (45) |
9 (26) /5 (14) /5 (14) / 16 (46) |
| Myeloma light chain, n (%) | ||
| Kappa light chain | 34 (89) | 25 (71) |
| Lambda light chain | 4 (11) | 10 (29) |
| Myeloma immunoglobulin, n (%) | ||
| IgA | 8 (21) | 8 (23) |
| IgG | 29 (76) | 22 (63) |
| IgM | 0 | 1 (3) |
| Other | 1 (3) | 4 (11) |
| Genetics, n (%)† | ||
| del13 | Not Available | 5 (14) |
| del17p13 | Not Available | 6 (17) |
| t(11:14) | Not Available | 2 (6) |
| t(4:14) | Not Available | 3 (9) |
| t(14:16) | Not Available | 1 (3) |
| +1q21 | Not Available | 3 (9) |
| Other | Not Available | 15 (43) |
| Missing | Not Available | 11 (31) |
| Prior therapies, n (%) | ||
| Received ≥5 lines of therapy | 29 (76) | 20 (57) |
| Proteasome inhibitors, received / refractory | 38 (100) | 35 (100) / 34 (97) |
| Immunomodulatory drugs, received / refractory | 38 (100) | 35 (100) / 32 (91) |
| Pomalidomide, received / refractory | 31 (82) | 21 (60) / 20 (57) |
| Daratumumab, received / refractory‡ | 9 (24) | 14 (40) / 13 (37) |
| Carfilzomib, received / refractory | 23 (61) | 28 (80) / 26 (74) |
| Patient disposition, n (%) | ||
| Completed study | 25 (66) | 9 (26) |
| Died | 1 (3) | 3 (9) |
| Ongoing on study | 10 (26) | 22 (63) |
| On treatment | 7 (18) | 17 (49) |
| In follow-up | 3 (8) | 5 (14) |
| Withdrawn from study | 2 (5) | 1 (3) |
| Withdrew consent | 1 (3) | 1 (3) |
| Lost to follow-up | 1 (3) | 0 |
| Discontinued treatment | 31 (82) | 18 (51) |
| Disease progression | 25 (66) | 15 (43) |
| Completion of treatment | 2 (5) | 0 |
| Adverse event | 3 (8) | 2 (6) |
| Corneal Event | 2 (5) | 00 |
| Investigator discretion | 1 (3) | 1 (3) |
| Patient decision | 0 |
*
Assessed using the International Staging System classification15; sum of categories <100% due to rounding.
†
Multiple categories per patient possible; total may add to more than 100%; assessed using fluorescence in situ hybridisation.
‡
Thirty-four percent of patients had prior daratumumab and were refractory to both immunomodulatory drugs and proteasome inhibitors.
Lactate dehydrogenase data at screening are not available.