TEAEs and hematologic laboratory abnormalities
| TEAEs . | Isatuximab dose in mg/kg and schedule . | . | |||
|---|---|---|---|---|---|
| No. of patients . | All patients, n = 45 . | ||||
| All grades/grade ≥3 . | n (%) . | ||||
| 5 QW/Q2W, n = 8 . | 10 QW/Q2W, n = 31 . | 20 QW/Q2W, n = 6 . | All grades . | Grade ≥3 . | |
| Any TEAE | 8/8 | 31/26 | 6/5 | 45 (100) | 39 (87) |
| TEAE leading to dose reduction of pomalidomide | 5/4 | 25/21 | 4/4 | 34 (82) | 29 (64) |
| TEAE leading to dose reduction of dexamethasone | 3/1 | 27/13 | 4/3 | 34 (76) | 17 (38) |
| SAE | 5/5 | 17/16 | 4/4 | 26 (58) | 25 (56) |
| Fatigue | 5/1 | 18/1 | 5/1 | 28 (62) | 3 (7) |
| IRR | 4/0 | 14/1 | 1/0 | 19 (42) | 1 (2) |
| URTI | 4/0 | 12/0 | 3/0 | 19 (42) | 0 |
| Dyspnea | 5/1 | 11/1 | 2/1 | 18 (40) | 3 (7) |
| Constipation | 4/0 | 10/0 | 2/0 | 16 (36) | 0 |
| Diarrhea | 2/0 | 11/1 | 3/0 | 16 (36) | 1 (2) |
| Cough | 3/0 | 9/0 | 2/0 | 14 (31) | 0 |
| Headache | 4/0 | 8/0 | 2/0 | 14 (31) | 0 |
| Insomnia | 2/0 | 11/1 | 0/0 | 13 (29) | 1 (2) |
| Nausea | 2/0 | 7/0 | 3/0 | 12 (27) | 0 |
| Dizziness | 4/1 | 5/0 | 2/0 | 11 (24) | 1 (2) |
| Pyrexia | 2/0 | 5/1 | 3/0 | 10 (22) | 1 (2) |
| Pneumonia | 0/0 | 8/7 | 2/1 | 10 (22) | 8 (18) |
| Pain in extremity | 2/0 | 7/1 | 1/1 | 10 (22) | 2 (4) |
| Urinary tract infection | 1/0 | 6/2 | 1/1 | 8 (18) | 3 (7) |
| Hypertension | 2/1 | 4/2 | 1/0 | 7 (16) | 3 (7) |
| Traumatic fracture | 2/2 | 3/1 | 1/0 | 6 (13) | 3 (7) |
| Syncope | 1/1 | 2/2 | 0/0 | 3 (7) | 3 (7) |
| Hematologic laboratory abnormalities* | |||||
| Lymphopenia | 8/7 | 29/21 | 6/4 | 43 (98) | 32 (73) |
| Leukopenia | 8/7 | 29/19 | 6/5 | 43 (98) | 31 (71) |
| Anemia | 8/0 | 29/3 | 6/2 | 43 (98) | 5 (11) |
| Neutropenia | 8/7 | 27/24 | 6/6 | 41 (93) | 37 (84) |
| Thrombocytopenia | 7/2 | 25/9 | 5/4 | 37 (84) | 15 (34) |
| TEAEs . | Isatuximab dose in mg/kg and schedule . | . | |||
|---|---|---|---|---|---|
| No. of patients . | All patients, n = 45 . | ||||
| All grades/grade ≥3 . | n (%) . | ||||
| 5 QW/Q2W, n = 8 . | 10 QW/Q2W, n = 31 . | 20 QW/Q2W, n = 6 . | All grades . | Grade ≥3 . | |
| Any TEAE | 8/8 | 31/26 | 6/5 | 45 (100) | 39 (87) |
| TEAE leading to dose reduction of pomalidomide | 5/4 | 25/21 | 4/4 | 34 (82) | 29 (64) |
| TEAE leading to dose reduction of dexamethasone | 3/1 | 27/13 | 4/3 | 34 (76) | 17 (38) |
| SAE | 5/5 | 17/16 | 4/4 | 26 (58) | 25 (56) |
| Fatigue | 5/1 | 18/1 | 5/1 | 28 (62) | 3 (7) |
| IRR | 4/0 | 14/1 | 1/0 | 19 (42) | 1 (2) |
| URTI | 4/0 | 12/0 | 3/0 | 19 (42) | 0 |
| Dyspnea | 5/1 | 11/1 | 2/1 | 18 (40) | 3 (7) |
| Constipation | 4/0 | 10/0 | 2/0 | 16 (36) | 0 |
| Diarrhea | 2/0 | 11/1 | 3/0 | 16 (36) | 1 (2) |
| Cough | 3/0 | 9/0 | 2/0 | 14 (31) | 0 |
| Headache | 4/0 | 8/0 | 2/0 | 14 (31) | 0 |
| Insomnia | 2/0 | 11/1 | 0/0 | 13 (29) | 1 (2) |
| Nausea | 2/0 | 7/0 | 3/0 | 12 (27) | 0 |
| Dizziness | 4/1 | 5/0 | 2/0 | 11 (24) | 1 (2) |
| Pyrexia | 2/0 | 5/1 | 3/0 | 10 (22) | 1 (2) |
| Pneumonia | 0/0 | 8/7 | 2/1 | 10 (22) | 8 (18) |
| Pain in extremity | 2/0 | 7/1 | 1/1 | 10 (22) | 2 (4) |
| Urinary tract infection | 1/0 | 6/2 | 1/1 | 8 (18) | 3 (7) |
| Hypertension | 2/1 | 4/2 | 1/0 | 7 (16) | 3 (7) |
| Traumatic fracture | 2/2 | 3/1 | 1/0 | 6 (13) | 3 (7) |
| Syncope | 1/1 | 2/2 | 0/0 | 3 (7) | 3 (7) |
| Hematologic laboratory abnormalities* | |||||
| Lymphopenia | 8/7 | 29/21 | 6/4 | 43 (98) | 32 (73) |
| Leukopenia | 8/7 | 29/19 | 6/5 | 43 (98) | 31 (71) |
| Anemia | 8/0 | 29/3 | 6/2 | 43 (98) | 5 (11) |
| Neutropenia | 8/7 | 27/24 | 6/6 | 41 (93) | 37 (84) |
| Thrombocytopenia | 7/2 | 25/9 | 5/4 | 37 (84) | 15 (34) |
TEAEs were defined as AEs that developed, worsened, or became serious during the TEAE period. The TEAE period was defined as the time from first dose of isatuximab, pomalidomide, or dexamethasone, whichever occurred first, up to 30 days after the last dose.
SAE, serious adverse event. See Table 1 for expansion of other abbreviations.
n = 30 for 10 mg/kg cohort; n = 44 for all patients.