Table 2.
Summary of TEAEs (Safety Population)
| n (%) | Isa-VCd (N = 17)a |
|---|---|
| Any TEAE | 17 (100) |
| Grade ≥3 TEAEs | 14 (82.4) |
| Drug-related TEAEs | 16 (94.1) |
| Drug-related TEAEs grade ≥3 | 8 (47.1) |
| Treatment-emergent SAEs | 9 (52.9) |
| Drug-related treatment-emergent SAEs | 4 (23.5) |
| TEAEs leading to deathb | 3 (17.6) |
| TEAEs leading to definitive study treatment discontinuationc | 3 (17.6) |
| TEAEs leading to premature study drug discontinuation | 1 (5.9) |
| Bortezomib | 0 |
| Cyclophosphamide | 0 |
| Dexamethasone | 1 (5.9) |
| Any DLT | 0 |
| Any AESI | 9 (52.9) |
| Any AESI grade ≥3 | 1 (5.9) |
| Any IR | 9 (52.9) |
| Any IR grade ≥3 | 1 (5.9) |
aIsa 10 mg/kg-VCd, n = 13; Isa 20 mg/kg-VCd, n = 4.
bPneumonia, sudden death.
cWhen Isa treatment was permanently discontinued, study treatment was terminated. TEAEs included grade 3 bronchospasm at day 1/cycle 1 in the context of a grade 3 IR, pneumonia, and sudden death.
AESI = adverse event of special interest; C = cyclophosphamide; d = dexamethasone; DLT = dose-limiting toxicity; IR = infusion reaction; Isa = isatuximab; SAE = serious AE; TEAE = treatment- emergent AE; V = bortezomib.