Patient demographics, baseline characteristics, and disposition
| Characteristic . | Isatuximab dose, mg/kg Q2W . | Isatuximab dose, mg/kg QW/Q2W . | Overall (n = 57) . | |||
|---|---|---|---|---|---|---|
| 3 (n = 4) . | 5 (n = 3) . | 10 (n = 24) . | 10 (n = 12) . | 20 (n = 14) . | ||
| Median age (range), y | 60 (48-69) | 65 (58-67) | 58 (45-74) | 60 (45-76) | 65 (42-74) | 61 (42-76) |
| Female/male, n (%) | 3/1 (75/25) | 1/2 (33/67) | 10/14 (42/58) | 7/5 (58/42) | 4/10 (29/71) | 25/32 (44/56) |
| Race, n (%) | ||||||
| White | 4 (100) | 3 (100) | 19 (79) | 8 (67) | 12 (86) | 46 (81) |
| Black | 0 | 0 | 3 (13) | 2 (17) | 2 (14) | 7 (12) |
| Other | 0 | 0 | 2 (8) | 2 (17) | 0 | 4 (7) |
| Median time since diagnosis (range), y | 7 (3-11) | 4 (3-4) | 5 (1-12) | 6 (2-12) | 4 (3-17) | 4 (1-17) |
| Type of myeloma at diagnosis, n (%) | ||||||
| IgG | 3 (75) | 3 (100) | 11 (46) | 7 (58) | 8 (57) | 32 (51) |
| IgA | 1 (25) | 0 | 3 (13) | 3 (25) | 3 (21) | 10 (18) |
| IgE | 0 | 0 | 1 (4) | 0 | 0 | 1 (2) |
| Light chain | 0 | 0 | 8 (33) | 2 (17) | 3 (21) | 13 (23) |
| Staging at diagnosis, n (%) | ||||||
| Stage I | 0 | 1 (33) | 4 (17) | 6 (50) | 5 (36) | 16 (28) |
| Stage II | 2 (50) | 1 (33) | 4 (17) | 1 (8) | 3 (21) | 11 (19) |
| Stage III | 1 (25) | 1 (33) | 11 (46) | 5 (42) | 4 (29) | 22 (39) |
| Missing | 1 (25) | 0 | 5 (21) | 0 | 2 (14) | 8 (14) |
| Bone marrow plasma cells, % | ||||||
| Mean (SD) | 43.3 (24.7) | 33.3 (28.9) | 39.0 (31.9)* | 37.9 (21.7)† | 47.7 (34.3)‡ | 40.9 (29.4) |
| Median (range) | 32.5 (28-50) | 50.0 (0-50) | 31.0 (0-91) | 35 (6-75)‡ | 40 (2-95) | 35 (0-95) |
| Plasmacytoma present at baseline, n (%) | 1 (25) | 0 | 3 (13) | 0 | 0 | 4 (7) |
| High-risk MM,§ n (%) | 1 (25) | 1 (33) | 8 (33) | 1 (8) | 4 (29) | 15 (26) |
| Median number of prior regimens (range) | 9.5 (3-14) | 7 (6-8) | 6.5 (2-12) | 6.5 (3-15) | 8 (5-12) | 7 (2-15) |
| Median number of prior lines (range) | 7 (3-12) | 6 (5-7) | 4 (1-10) | 5 (1-8) | 6.5 (3-10) | 5 (1-12) |
| Patients with prior stem cell transplant (%) | 4 (100) | 2 (67) | 23 (96) | 12 (100) | 13 (93) | 54 (95) |
| Patients with prior therapy | ||||||
| LEN, n (%) | 4 (100) | 3 (100) | 22 (92) | 11 (92) | 14 (100) | 54 (95) |
| Refractory to LEN, n/N (%) | 4/4 (100) | 1/3 (33) | 21/22 (95) | 8/11 (73) | 13/14 (93) | 47/54 (87) |
| POM, n (%) | 1 (25) | 1 (33) | 8 (33) | 6 (50) | 11 (79) | 27 (47) |
| Refractory to POM, n/N (%) | 1/1 (100) | 1/1 (100) | 8/8 (100) | 6/6 (100) | 11/11 (100) | 27/27 (100) |
| BORT, n (%) | 4 (100) | 3 (100) | 22 (92) | 11 (92) | 14 (100) | 54 (95) |
| Refractory to BORT, n/N (%) | 1/4 (25) | 3/3 (100) | 15/22 (68) | 6/11 (55) | 10/14 (71) | 35/54 (65) |
| CAR, n (%) | 1 (25) | 2 (67) | 13 (54) | 9 (75) | 12 (86) | 37 (65) |
| Refractory to CAR, n/N (%) | 1/1 (100) | 2/2 (100) | 13/13 (100) | 6/9 (67) | 12/12 (100) | 34/37 (92) |
| Refractory to IMiD-containing regimen | 4 (100) | 2 (67) | 21 (88) | 9 (75) | 14 (100) | 50 (88) |
| Characteristic . | Isatuximab dose, mg/kg Q2W . | Isatuximab dose, mg/kg QW/Q2W . | Overall (n = 57) . | |||
|---|---|---|---|---|---|---|
| 3 (n = 4) . | 5 (n = 3) . | 10 (n = 24) . | 10 (n = 12) . | 20 (n = 14) . | ||
| Median age (range), y | 60 (48-69) | 65 (58-67) | 58 (45-74) | 60 (45-76) | 65 (42-74) | 61 (42-76) |
| Female/male, n (%) | 3/1 (75/25) | 1/2 (33/67) | 10/14 (42/58) | 7/5 (58/42) | 4/10 (29/71) | 25/32 (44/56) |
| Race, n (%) | ||||||
| White | 4 (100) | 3 (100) | 19 (79) | 8 (67) | 12 (86) | 46 (81) |
| Black | 0 | 0 | 3 (13) | 2 (17) | 2 (14) | 7 (12) |
| Other | 0 | 0 | 2 (8) | 2 (17) | 0 | 4 (7) |
| Median time since diagnosis (range), y | 7 (3-11) | 4 (3-4) | 5 (1-12) | 6 (2-12) | 4 (3-17) | 4 (1-17) |
| Type of myeloma at diagnosis, n (%) | ||||||
| IgG | 3 (75) | 3 (100) | 11 (46) | 7 (58) | 8 (57) | 32 (51) |
| IgA | 1 (25) | 0 | 3 (13) | 3 (25) | 3 (21) | 10 (18) |
| IgE | 0 | 0 | 1 (4) | 0 | 0 | 1 (2) |
| Light chain | 0 | 0 | 8 (33) | 2 (17) | 3 (21) | 13 (23) |
| Staging at diagnosis, n (%) | ||||||
| Stage I | 0 | 1 (33) | 4 (17) | 6 (50) | 5 (36) | 16 (28) |
| Stage II | 2 (50) | 1 (33) | 4 (17) | 1 (8) | 3 (21) | 11 (19) |
| Stage III | 1 (25) | 1 (33) | 11 (46) | 5 (42) | 4 (29) | 22 (39) |
| Missing | 1 (25) | 0 | 5 (21) | 0 | 2 (14) | 8 (14) |
| Bone marrow plasma cells, % | ||||||
| Mean (SD) | 43.3 (24.7) | 33.3 (28.9) | 39.0 (31.9)* | 37.9 (21.7)† | 47.7 (34.3)‡ | 40.9 (29.4) |
| Median (range) | 32.5 (28-50) | 50.0 (0-50) | 31.0 (0-91) | 35 (6-75)‡ | 40 (2-95) | 35 (0-95) |
| Plasmacytoma present at baseline, n (%) | 1 (25) | 0 | 3 (13) | 0 | 0 | 4 (7) |
| High-risk MM,§ n (%) | 1 (25) | 1 (33) | 8 (33) | 1 (8) | 4 (29) | 15 (26) |
| Median number of prior regimens (range) | 9.5 (3-14) | 7 (6-8) | 6.5 (2-12) | 6.5 (3-15) | 8 (5-12) | 7 (2-15) |
| Median number of prior lines (range) | 7 (3-12) | 6 (5-7) | 4 (1-10) | 5 (1-8) | 6.5 (3-10) | 5 (1-12) |
| Patients with prior stem cell transplant (%) | 4 (100) | 2 (67) | 23 (96) | 12 (100) | 13 (93) | 54 (95) |
| Patients with prior therapy | ||||||
| LEN, n (%) | 4 (100) | 3 (100) | 22 (92) | 11 (92) | 14 (100) | 54 (95) |
| Refractory to LEN, n/N (%) | 4/4 (100) | 1/3 (33) | 21/22 (95) | 8/11 (73) | 13/14 (93) | 47/54 (87) |
| POM, n (%) | 1 (25) | 1 (33) | 8 (33) | 6 (50) | 11 (79) | 27 (47) |
| Refractory to POM, n/N (%) | 1/1 (100) | 1/1 (100) | 8/8 (100) | 6/6 (100) | 11/11 (100) | 27/27 (100) |
| BORT, n (%) | 4 (100) | 3 (100) | 22 (92) | 11 (92) | 14 (100) | 54 (95) |
| Refractory to BORT, n/N (%) | 1/4 (25) | 3/3 (100) | 15/22 (68) | 6/11 (55) | 10/14 (71) | 35/54 (65) |
| CAR, n (%) | 1 (25) | 2 (67) | 13 (54) | 9 (75) | 12 (86) | 37 (65) |
| Refractory to CAR, n/N (%) | 1/1 (100) | 2/2 (100) | 13/13 (100) | 6/9 (67) | 12/12 (100) | 34/37 (92) |
| Refractory to IMiD-containing regimen | 4 (100) | 2 (67) | 21 (88) | 9 (75) | 14 (100) | 50 (88) |