Table 3.
Adverse events.
| N (%) | VRd (N=37) | D-VTd (N=43) | P a) | |||
|---|---|---|---|---|---|---|
| Any | Grade ≥3 | Any | Grade ≥3 | |||
| Hematologic AE | ||||||
| Neutropenia | 1 (2.7) | 1 (2.7) | 4 (9.3) | 4 (9.3) | 0.224 | |
| Thrombocytopenia | 0 | 0 | 0 | 0 | NA | |
| Lymphopenia | 1 (2.7) | 0 | 1 (2.3) | 0 | 0.914 | |
| Non-hematologic AE | ||||||
| Peripheral neuropathy | 11 (29.7) | 0 | 9 (20.9) | 0 | 0.365 | |
| Constipation | 12 (32.4) | 1 (2.7) | 12 (27.9) | 0 | 0.660 | |
| Skin rashb) | 11 (29.7) | 3 (8.1) | 5 (11.6) | 1 (2.3) | 0.044 | |
| Pruritisc) | 8 (21.6) | 1 (2.7) | 3 (7.0) | 0 | 0.058 | |
| Edema | 5 (13.5) | 0 | 2 (4.7) | 0 | 0.162 | |
| Nausea | 4 (10.8) | 0 | 6 (14.0) | 0 | 0.672 | |
| Documented infection | 4 (10.8) | 2 (4.7) | 0.297 | |||
| Viral | 2 | 1 | ||||
| Bacterial | 2 | 1 | ||||
| Fungal | 0 | 0 | ||||
| Daratumumab IRR | NA | 19 (44.2%) | 0 | NA | ||
| Cycle 1 | 18 | 0 | ||||
| Cycle 2 | 0 | 0 | ||||
| Cycle 3 | 0 | 0 | ||||
| Cycle 4 | 1 | 0 | ||||
| IMiD dose reduction | NA | |||||
| Lenalidomide | 6 (16.2) | NA | ||||
| Thalidomide | NA | 6 (13.6) | ||||
a)P-value for adverse events. b)P-value for grade ≥3 skin rash, P=0.237. c)P-value for grade ≥3 pruritis, P=0.278.
Abbreviations: AE, adverse events; IMiD, immunomodulatory drug; IRR, infusion-related reaction; NA, not applicable.