Baseline characteristics and prior treatment
| Characteristic . | Isatuximab dose in mg/kg and schedule . | All patients, n = 45 . | ||
|---|---|---|---|---|
| 5 QW/Q2W, n = 8 . | 10 QW/Q2W,* n = 31 . | 20 QW/Q2W, n = 6 . | ||
| Median age (range), y | 65.0 (56-77) | 67.0 (42-82) | 65.5 (58-75) | 67.0 (42-82) |
| Median time since diagnosis (range), y | 3.46 (1.0-9.1) | 4.30 (1.6-15.8) | 5.18 (2.7-14.0) | 4.30 (1.0-15.8) |
| ISS stage at baseline, n (%) | ||||
| I | 5 (63) | 15 (48) | 2 (33) | 22 (49) |
| II | 2 (25) | 11 (36) | 4 (67) | 17 (38) |
| III | 1 (13) | 3 (10) | 0 | 4 (9) |
| Missing | 0 | 2 (7) | 0 | 2 (4) |
| Type of myeloma at diagnosis, n (%) | ||||
| IgA | 1 (13) | 4 (13) | 0 | 5 (11) |
| IgG | 3 (38) | 19 (61) | 5 (83) | 27 (60) |
| Light chain, κ and λ | 4 (50) | 7 (23) | 1 (17) | 12 (27) |
| Unknown | 0 | 1 (3) | 0 | 1 (2) |
| Cytogenetic risk at baseline, n (%) | ||||
| Standard | 6 (75) | 17 (55) | 3 (50) | 26 (58) |
| High* | 1 (13) | 3 (10) | 2 (33) | 6 (13) |
| Missing | 1 (13) | 11 (65) | 1 (17) | 13 (29) |
| Median bone marrow plasma cells at baseline, % (range) | 40 (5-90) | 25 (0-90) | 35 (11-80) | 27.8 (0-90) |
| Prior treatment of multiple myeloma and refractory status | ||||
| Median prior regimens, n (range) | 5 (3-7) | 5 (3-12) | 4 (4-5) | 5 (3-12) |
| Median prior lines, n (range) | 3 (2-4) | 3 (1-10) | 2 (1-4) | 3 (1-10) |
| Prior stem cell transplant, n (%) | ||||
| ≥1 | 6 (75) | 19 (61) | 5 (83) | 30 (67) |
| ≥2 | 2 (25) | 1 (3) | 2 (33) | 5 (11) |
| Refractory to, n (%) | ||||
| Lenalidomide | 6 (75) | 27 (87) | 4 (67) | 37 (82) |
| Pomalidomide | 0 | 3 (10) | 1 (17) | 4 (9) |
| Bortezomib | 5 (63) | 22 (71) | 2 (33) | 29 (64) |
| Carfilzomib | 3 (38) | 13 (42) | 2 (33) | 18 (40) |
| IMiD refractory, n (%) | 6 (75) | 27 (87) | 4 (67) | 37 (82) |
| PI refractory, n (%) | 7 (88) | 27 (87) | 4 (67) | 38 (84) |
| IMiD + PI refractory, n (%) | 5 (63) | 23 (74) | 4 (67) | 32 (71) |
| Refractory to last regimen, n (%) | 8 (100) | 29 (94) | 4 (67) | 41 (91) |
| Refractory to lenalidomide and bortezomib, n (%) | 3 (38) | 18 (58) | 2 (33) | 23 (51) |
| Refractory to lenalidomide and carfilzomib, n (%) | 3 (38) | 13 (42) | 2 (33) | 18 (40) |
| Refractory to lenalidomide, bortezomib, and carfilzomib, n (%) | 2 (25) | 8 (26) | 0 | 10 (22) |
| Refractory to lenalidomide, pomalidomide, bortezomib, and carfilzomib, n (%) | 0 | 2 (7) | 0 | 2 (4) |
| Characteristic . | Isatuximab dose in mg/kg and schedule . | All patients, n = 45 . | ||
|---|---|---|---|---|
| 5 QW/Q2W, n = 8 . | 10 QW/Q2W,* n = 31 . | 20 QW/Q2W, n = 6 . | ||
| Median age (range), y | 65.0 (56-77) | 67.0 (42-82) | 65.5 (58-75) | 67.0 (42-82) |
| Median time since diagnosis (range), y | 3.46 (1.0-9.1) | 4.30 (1.6-15.8) | 5.18 (2.7-14.0) | 4.30 (1.0-15.8) |
| ISS stage at baseline, n (%) | ||||
| I | 5 (63) | 15 (48) | 2 (33) | 22 (49) |
| II | 2 (25) | 11 (36) | 4 (67) | 17 (38) |
| III | 1 (13) | 3 (10) | 0 | 4 (9) |
| Missing | 0 | 2 (7) | 0 | 2 (4) |
| Type of myeloma at diagnosis, n (%) | ||||
| IgA | 1 (13) | 4 (13) | 0 | 5 (11) |
| IgG | 3 (38) | 19 (61) | 5 (83) | 27 (60) |
| Light chain, κ and λ | 4 (50) | 7 (23) | 1 (17) | 12 (27) |
| Unknown | 0 | 1 (3) | 0 | 1 (2) |
| Cytogenetic risk at baseline, n (%) | ||||
| Standard | 6 (75) | 17 (55) | 3 (50) | 26 (58) |
| High* | 1 (13) | 3 (10) | 2 (33) | 6 (13) |
| Missing | 1 (13) | 11 (65) | 1 (17) | 13 (29) |
| Median bone marrow plasma cells at baseline, % (range) | 40 (5-90) | 25 (0-90) | 35 (11-80) | 27.8 (0-90) |
| Prior treatment of multiple myeloma and refractory status | ||||
| Median prior regimens, n (range) | 5 (3-7) | 5 (3-12) | 4 (4-5) | 5 (3-12) |
| Median prior lines, n (range) | 3 (2-4) | 3 (1-10) | 2 (1-4) | 3 (1-10) |
| Prior stem cell transplant, n (%) | ||||
| ≥1 | 6 (75) | 19 (61) | 5 (83) | 30 (67) |
| ≥2 | 2 (25) | 1 (3) | 2 (33) | 5 (11) |
| Refractory to, n (%) | ||||
| Lenalidomide | 6 (75) | 27 (87) | 4 (67) | 37 (82) |
| Pomalidomide | 0 | 3 (10) | 1 (17) | 4 (9) |
| Bortezomib | 5 (63) | 22 (71) | 2 (33) | 29 (64) |
| Carfilzomib | 3 (38) | 13 (42) | 2 (33) | 18 (40) |
| IMiD refractory, n (%) | 6 (75) | 27 (87) | 4 (67) | 37 (82) |
| PI refractory, n (%) | 7 (88) | 27 (87) | 4 (67) | 38 (84) |
| IMiD + PI refractory, n (%) | 5 (63) | 23 (74) | 4 (67) | 32 (71) |
| Refractory to last regimen, n (%) | 8 (100) | 29 (94) | 4 (67) | 41 (91) |
| Refractory to lenalidomide and bortezomib, n (%) | 3 (38) | 18 (58) | 2 (33) | 23 (51) |
| Refractory to lenalidomide and carfilzomib, n (%) | 3 (38) | 13 (42) | 2 (33) | 18 (40) |
| Refractory to lenalidomide, bortezomib, and carfilzomib, n (%) | 2 (25) | 8 (26) | 0 | 10 (22) |
| Refractory to lenalidomide, pomalidomide, bortezomib, and carfilzomib, n (%) | 0 | 2 (7) | 0 | 2 (4) |
ISS, International Staging System; QW/Q2W, weekly administration in cycle 1 followed by every other week for subsequent cycles.
Duration of exposure was censored at day 1 in patients with no evaluable postbaseline disease assessment.