Table 2.
Median relative dose intensity and duration of exposure of each combination drug.
| Part A | Part B | |
|---|---|---|
| (n = 27) | (n = 46) | |
| Median relative dose intensity, % (range) | ||
| Isatuximab | 92.17 | 89.92a |
| (23.2–100.3) | (75.0–100.8) | |
| Bortezomib | 95.57 | 89.36 |
| (67.6–235.8) | (28.6–118.8) | |
| Lenalidomide | 72.77 | 92.25 |
| (38.1–105.3) | (8.33–123.52) | |
| Dexamethasone | 98.31 | 75.24 |
| (40.1–247.1) | (23.9–185.2) | |
| Median duration of exposure, weeks (range) | ||
| Isatuximab | 159 | 114.93 |
| (1.0–206.1) | (3.9–144.3) | |
| Bortezomib | 22.43 | 23.36 |
| (2.9–28.3) | (3.3–55.7) | |
| Lenalidomide | 105.71 | 109.36 |
| (15.1–203.3) | (6.0–145.0) | |
| Dexamethasone | 123 | 108.43 |
| (0.1–201.4) | (3.0–142.4) | |
aThe relative dose intensity for isatuximab was lower than expected due to the schedule of isatuximab administration during the maintenance phase being changed from every 2 weeks to every 4 weeks after protocol amendment 11. The change was not incorporated in the calculation and Day 15 was considered as dose omission.