Patient demographic data, disease characteristics, and treatment history (randomized population)
| Variable . | Isatuximab monotherapy (n = 109) . | Isatuximab + dexamethasone (n = 55) . |
|---|---|---|
| Age, median (range), y | 68 (37–84) | 66 (42–85) |
| ≥75 y | 21 (19.3) | 12 (21.8) |
| Female, n (%) | 58 (53.2) | 26 (47.3) |
| Race, n (%) | ||
| White | 91 (83.5) | 45 (81.8) |
| Black or African American | 5 (4.6) | 3 (5.5) |
| Asian | 0 | 1 (1.8) |
| Other | 13 (11.9) | 6 (10.9) |
| Ethnicity, n (%) | ||
| Hispanic or Latino | 19 (17.4) | 9 (16.4) |
| Not Hispanic or Latino | 90 (82.6) | 46 (83.6) |
| Geographic region, n (%) | ||
| Europe | 62 (56.9) | 31 (56.4) |
| North America | 23 (21.1) | 10 (18.2) |
| Other | 24 (22.0) | 14 (25.5) |
| ECOG PS score (Karnofsky PS), n (%) | ||
| 0 (100%) | 48 (44.0) | 27 (49.1) |
| 1 (80–90%) | 54 (49.5) | 22 (40.0) |
| 2 (60–70%) | 7 (6.4) | 6 (10.9) |
| Time since initial diagnosis, median (range), y | 5.3 (0.7–21.1) | 5.6 (1.2–23.0) |
| Type of myeloma at diagnosis, n (%) | ||
| Immunoglobulin A | 20 (18.3) | 12 (21.8) |
| Immunoglobulin G | 45 (41.3) | 29 (52.7) |
| Light chain (κ and λ) | 33 (30.3) | 10 (18.2) |
| Measurable paraprotein at baseline,*n (%) | ||
| Serum M-protein | 75 (68.8) | 40 (72.7) |
| Urine M-protein | 12 (11.0) | 10 (18.2) |
| κ light chain | 11 (10.1) | 1 (1.8) |
| λ light chain | 10 (9.2) | 3 (5.5) |
| ISS stage at baseline,†n (%) | ||
| I | 27 (24.8) | 15 (27.3) |
| II | 37 (33.9) | 20 (36.4) |
| III | 45 (41.3) | 20 (36.4) |
| Bone marrow plasma cells, median (range), % | 23.5 (0.0-100) | 29.0 (1.0-100) |
| Plasmacytoma at baseline,† n (%) | 21 (19.3) | 17 (30.9) |
| High-risk cytogenetics,†‡ n (%) | 23 (21.1) | 12 (21.8) |
| CrCl 15-60 mL/min/1.73 m2,§ n (%) | 38 (34.9) | 18 (32.7) |
| Prior lines of therapy, median (range) | 4 (2-10) | 4 (2-10) |
| Prior regimens, median (range) | 5 (2-16) | 5 (2-14) |
| ≥1 prior stem cell transplant, n (%) | 59 (54.1) | 28 (50.9) |
| Refractory to an IMiD,ǁ n (%) | 93 (85.3) | 50 (90.9) |
| Refractory to lenalidomide | 77 (70.6) | 34 (61.8) |
| Refractory to pomalidomide | 41 (37.6) | 23 (41.8) |
| Refractory to a PI,ǁ n (%) | 88 (80.7) | 46 (83.6) |
| Refractory to bortezomib | 71 (65.1) | 37 (67.3) |
| Refractory to carfilzomib | 30 (27.5) | 11 (20.0) |
| Refractory to alkylating agent, n (%)ǁ | 75 (68.8) | 34 (61.8) |
| Double refractory, n (%)ǁ,¶ | 76 (69.7) | 42 (76.4) |
| Quadruple refractory, n (%)ǁ,# | 7 (6.4) | 4 (7.3) |
| Refractory to last regimen, n (%)ǁ | 99 (90.8) | 49 (89.1) |
| Variable . | Isatuximab monotherapy (n = 109) . | Isatuximab + dexamethasone (n = 55) . |
|---|---|---|
| Age, median (range), y | 68 (37–84) | 66 (42–85) |
| ≥75 y | 21 (19.3) | 12 (21.8) |
| Female, n (%) | 58 (53.2) | 26 (47.3) |
| Race, n (%) | ||
| White | 91 (83.5) | 45 (81.8) |
| Black or African American | 5 (4.6) | 3 (5.5) |
| Asian | 0 | 1 (1.8) |
| Other | 13 (11.9) | 6 (10.9) |
| Ethnicity, n (%) | ||
| Hispanic or Latino | 19 (17.4) | 9 (16.4) |
| Not Hispanic or Latino | 90 (82.6) | 46 (83.6) |
| Geographic region, n (%) | ||
| Europe | 62 (56.9) | 31 (56.4) |
| North America | 23 (21.1) | 10 (18.2) |
| Other | 24 (22.0) | 14 (25.5) |
| ECOG PS score (Karnofsky PS), n (%) | ||
| 0 (100%) | 48 (44.0) | 27 (49.1) |
| 1 (80–90%) | 54 (49.5) | 22 (40.0) |
| 2 (60–70%) | 7 (6.4) | 6 (10.9) |
| Time since initial diagnosis, median (range), y | 5.3 (0.7–21.1) | 5.6 (1.2–23.0) |
| Type of myeloma at diagnosis, n (%) | ||
| Immunoglobulin A | 20 (18.3) | 12 (21.8) |
| Immunoglobulin G | 45 (41.3) | 29 (52.7) |
| Light chain (κ and λ) | 33 (30.3) | 10 (18.2) |
| Measurable paraprotein at baseline,*n (%) | ||
| Serum M-protein | 75 (68.8) | 40 (72.7) |
| Urine M-protein | 12 (11.0) | 10 (18.2) |
| κ light chain | 11 (10.1) | 1 (1.8) |
| λ light chain | 10 (9.2) | 3 (5.5) |
| ISS stage at baseline,†n (%) | ||
| I | 27 (24.8) | 15 (27.3) |
| II | 37 (33.9) | 20 (36.4) |
| III | 45 (41.3) | 20 (36.4) |
| Bone marrow plasma cells, median (range), % | 23.5 (0.0-100) | 29.0 (1.0-100) |
| Plasmacytoma at baseline,† n (%) | 21 (19.3) | 17 (30.9) |
| High-risk cytogenetics,†‡ n (%) | 23 (21.1) | 12 (21.8) |
| CrCl 15-60 mL/min/1.73 m2,§ n (%) | 38 (34.9) | 18 (32.7) |
| Prior lines of therapy, median (range) | 4 (2-10) | 4 (2-10) |
| Prior regimens, median (range) | 5 (2-16) | 5 (2-14) |
| ≥1 prior stem cell transplant, n (%) | 59 (54.1) | 28 (50.9) |
| Refractory to an IMiD,ǁ n (%) | 93 (85.3) | 50 (90.9) |
| Refractory to lenalidomide | 77 (70.6) | 34 (61.8) |
| Refractory to pomalidomide | 41 (37.6) | 23 (41.8) |
| Refractory to a PI,ǁ n (%) | 88 (80.7) | 46 (83.6) |
| Refractory to bortezomib | 71 (65.1) | 37 (67.3) |
| Refractory to carfilzomib | 30 (27.5) | 11 (20.0) |
| Refractory to alkylating agent, n (%)ǁ | 75 (68.8) | 34 (61.8) |
| Double refractory, n (%)ǁ,¶ | 76 (69.7) | 42 (76.4) |
| Quadruple refractory, n (%)ǁ,# | 7 (6.4) | 4 (7.3) |
| Refractory to last regimen, n (%)ǁ | 99 (90.8) | 49 (89.1) |
CrCl, creatinine clearance; ECOG, Eastern Cooperative Oncology Group; ISS, International Staging System; PS, performance status.
One patient in each arm had data missing.
Based on central laboratory data.
High-risk cytogenetics status, defined as presence of t(4;14) and/or del(17p), was unknown in 48 patients (29 patients in Isa arm and 19 patients in Isa-dex arm), based on central laboratory data (n = 100) and local laboratory data (n = 16).
Eight patients (4 in each arm) had CrCl 15 to 30 mL/min/1.73 m2.
ǁRefractory disease defined according to International Myeloma Working Group criteria.
Refractory to IMiD and PI.
Refractory to lenalidomide, bortezomib, pomalidomide, and carfilzomib.