TABLE 2.
Summary of patient demographics and other baseline characteristics (ITT/randomized population).
| Isa (n = 34) | Isa + CemiQ2W (n = 36) | Isa + CemiQ4W (n = 36) | All (N = 106) | |
|---|---|---|---|---|
| Age (years) | ||||
| Median (range) | 68.0 (41–82) | 64.0 (45–84) | 66.5 (49–86) | 66.0 (41–86) |
| Age group, n (%) | ||||
| <65 years | 11 (32.4) | 20 (55.6) | 14 (38.9) | 45 (42.5) |
| 65–74 years | 18 (52.9) | 9 (25.0) | 15 (41.7) | 42 (39.6) |
| ≥75 years | 5 (14.7) | 7 (19.4) | 7 (19.4) | 19 (17.9) |
| Race, n (%) | ||||
| Asian | 0 | 0 | 1 (2.8) | 1 (0.9) |
| Black or African American | 2 (5.9) | 3 (8.3) | 3 (8.3) | 8 (7.5) |
| White | 29 (85.3) | 30 (83.3) | 29 (80.6) | 88 (83.0) |
| Missing/Not reported | 3 (8.8) | 3 (8.3) | 2 (5.6) | 8 (7.5) |
| Unknown | 0 | 0 | 1 (2.8) | 1 (0.9) |
| ECOG PS, n (%) | ||||
| 0 | 13 (38.2) | 11 (30.6) | 16 (44.4) | 40 (37.7) |
| 1 | 21 (61.8) | 22 (61.1) | 19 (52.8) | 62 (58.5) |
| 2 | 0 | 3 (8.3) | 1 (2.8) | 4 (3.8) |
| Cytogenetic risk status, n (%) | ||||
| High a | 8 (23.5) | 11 (30.6) | 8 (22.2) | 27 (25.5) |
| Standard | 13 (38.2) | 9 (25.0) | 16 (44.4) | 38 (35.8) |
| Unknown/missing | 13 (38.2) | 16 (44.4) | 12 (33.3) | 41 (38.7) |
| MM subtype at study entry, n (%) | ||||
| IgG | 18 (52.9) | 25 (69.4) | 22 (61.1) | 65 (61.3) |
| IgA | 11 (32.4) | 5 (13.9) | 7 (19.4) | 23 (21.7) |
| IgM | 0 | 1 (2.8) | 1 (2.8) | 2 (1.9) |
| IgD | 0 | 0 | 1 (2.8) | 1 (0.9) |
| IgE | 0 | 0 | 0 | 0 |
| Kappa light chain only | 2 (5.9) | 2 (5.6) | 4 (11.1) | 8 (7.5) |
| Lambda light chain only | 3 (8.8) | 3 (8.3) | 1 (2.8) | 7 (6.6) |
| ISS stage at study entry, n (%) | ||||
| Stage I | 7 (20.6) | 15 (41.7) | 14 (38.9) | 36 (34.0) |
| Stage II | 20 (58.8) | 8 (22.2) | 11 (30.6) | 39 (36.8) |
| Stage III | 7 (20.6) | 13 (36.1) | 8 (22.2) | 28 (26.4) |
| Unknown | 0 | 0 | 3 (8.3) | 3 (2.8) |
| Creatinine clearance, n (%) | ||||
| <60 mL/min/1.73 m2 | 14 (41.2) | 11 (30.6) | 8 (22.2) | 33 (31.1) |
| ≥60 mL/min/1.73 m2 | 17 (50.0) | 22 (61.1) | 25 (69.4) | 64 (60.4) |
| Missing | 3 (8.8) | 3 (8.3) | 3 (8.3) | 9 (8.5) |
| Bone marrow plasma cells at baseline, n (%) | ||||
| ≥50% | 10 (29.4) | 11 (30.6) | 8 (22.2) | 29 (27.4) |
| Missing | 1 (2.9) | 1 (2.8) | 0 | 2 (1.9) |
| Number of prior lines by patient | ||||
| Median (range) | 4.0 (2.0–11.0) | 4.0 (2.0–9.0) | 4.0 (2.0–11.0) | 4.0 (2.0–11.0) |
| 2 b | 2 (5.9) | 2 (5.6) | 5 (13.9) | 9 (8.5) |
| 3 | 5 (14.7) | 12 (33.3) | 11 (30.6) | 28 (26.4) |
| 4 | 12 (35.3) | 8 (22.2) | 9 (25.0) | 29 (27.4) |
| 5 | 4 (11.8) | 8 (22.2) | 4 (11.1) | 16 (15.1) |
| 6 | 3 (8.8) | 1 (2.8) | 3 (8.3) | 7 (6.6) |
| 7 | 2 (5.9) | 3 (8.3) | 2 (5.6) | 7 (6.6) |
| ≥8 | 6 (17.6) | 2 (5.6) | 2 (5.6) | 10 (9.4) |
| Main prior treatments, n (%) | ||||
| Alkylating agent | 32 (94.1) | 32 (88.9) | 34 (94.4) | 98 (92.5) |
| Immunomodulatory drug | 34 (100) | 36 (100) | 36 (100) | 106 (100) |
| Lenalidomide | 29 (85.3) | 36 (100) | 28 (77.8) | 93 (87.7) |
| Pomalidomide | 20 (58.8) | 22 (61.1) | 14 (38.9) | 56 (52.8) |
| Thalidomide | 19 (55.9) | 16 (44.4) | 18 (50.0) | 53 (50.0) |
| Proteasome inhibitor | 34 (100) | 35 (97.2) | 36 (100) | 105 (99.1) |
| Bortezomib | 34 (100) | 34 (94.4) | 36 (100) | 104 (98.1) |
| Carfilzomib | 15 (44.1) | 20 (55.6) | 12 (33.3) | 47 (44.3) |
| Ixazomib | 4 (11.8) | 4 (11.1) | 2 (5.6) | 10 (9.4) |
| Monoclonal antibodies | 12 (35.3) | 8 (22.2) | 12 (33.3) | 32 (30.2) |
| Daratumumab | 11 (32.4) | 6 (16.7) | 11 (30.6) | 28 (26.4) |
| Elotuzumab | 1 (2.9) | 3 (8.3) | 5 (13.9) | 9 (8.5) |
| Refractory status | ||||
| Refractory to IMiD | 29 (85.3) | 33 (91.7) | 26 (72.2) | 88 (83.0) |
| Refractory to PI | 20 (58.8) | 31 (86.1) | 25 (69.4) | 76 (71.7) |
| Refractory to IMiD and PI | 19 (55.9) | 29 (80.6) | 19 (52.8) | 67 (63.2) |
| Refractory to last regimen | 27 (79.4) | 33 (91.7) | 29 (80.6) | 89 (84.0) |
Abbreviations: Cemi, cemiplimab; ECOG PS, Eastern Cooperative Oncology Group performance status; Ig, immunoglobulin; IMiD, immunomodulatory drug; Isa, isatuximab; ISS, International Staging System; ITT, intent‐to‐treat; MM, multiple myeloma; PI, proteasome inhibitor; Q2W, every 2 weeks; Q4W, every 4 weeks.
a
High‐risk defined as presence of del(17p) (10% cutoff), and/or t(4;14) (15% cutoff), and/or t(14;16) (15% cutoff).
b
Patients (n = 9) with <3 lines of therapy were included by mistake.