Table II.
Baseline demographic characteristics by risk status.
|
High‐risk CA (n = 60) |
Standard‐risk CA (n = 181) | |||
|---|---|---|---|---|
| Isa–Pd (n = 24) | Pd (n = 36) | Isa–Pd (n = 103) | Pd (n = 78) | |
| Age, y | ||||
| Mean (SD) | 68·0 (8·1) | 65·6 (10·8) | 66·5 (9·3) | 64·7 (8·5) |
| Median | 67·5 | 64·0 | 68·0 | 66·0 |
| Min; max | 52; 83 | 41; 86 | 36; 81 | 41; 85 |
| Age group (y), n (%) | ||||
| <65 | 8 (33·3) | 19 (52·8) | 36 (35·0) | 37 (47·4) |
| 65–74 | 9 (37·5) | 6 (16·7) | 47 (45·6) | 32 (41·0) |
| ≥75 | 7 (29·2) | 11 (30·6) | 20 (19·4) | 9 (11·5) |
| ECOG performance status, n (%) | ||||
| 0 | 6 (25·0) | 20 (55·6) | 38 (36·9) | 30 (38·5) |
| 1 | 14 (58·3) | 10 (27·8) | 54 (52·4) | 41 (52·6) |
| 2 | 4 (16·7) | 6 (16·7) | 11 (10·7) | 7 (9·0) |
| Geographical region, n (%) | ||||
| Western Europe | 11 (45·8) | 24 (66·7) | 34 (33·0) | 33 (42·3) |
| Eastern Europe | 4 (16·7) | 3 (8·3) | 20 (19·4) | 13 (16·7) |
| North America | 1 (4·2) | 1 (2·8) | 5 (4·9) | 2 (2·6) |
| Asia | 3 (12·5) | 2 (5·6) | 14 (13·6) | 9 (11·5) |
| Other countries* | 5 (20·8) | 6 (16·7) | 30 (29·1) | 21 (26·9) |
| MM subtype at study entry†, n (%) | ||||
| IgG | 15 (62·5) | 27 (75·0) | 71 (68·9) | 52 (66·7) |
| IgA | 7 (29·2) | 9 (25·0) | 19 (18·4) | 19 (24·4) |
| IgM | 0 | 0 | 2 (1·9) | 0 |
| IgD | 0 | 0 | 0 | 0 |
| IgE | 0 | 0 | 0 | 0 |
| Kappa light chain only | 1 (4·2) | 0 | 7 (6·8) | 4 (5·1) |
| Lambda light chain only | 1 (4·2) | 0 | 4 (3·9) | 3 (3·8) |
| Serum LDH, n (%) | ||||
| ≤ULN | 13 (54·2) | 22 (61·1) | 73 (70·9) | 55 (70·5) |
| >ULN | 11 (45·8) | 14 (38·9) | 30 (29·1) | 23 (29·5) |
| ISS stage at study entry, n (%) | ||||
| Stage I | 8 (33·3) | 9 (25·0) | 43 (41·7) | 26 (33·3) |
| Stage II | 8 (33·3) | 15 (41·7) | 36 (35·0) | 29 (37·2) |
| Stage III | 8 (33·3) | 12 (33·3) | 21 (20·4) | 22 (28·2) |
| Unknown | 0 | 0 | 3 (2·9) | 1 (1·3) |
| R‐ISS stage at study entry, n (%) | ||||
| Stage I | 0 | 0 | 31 (30·1) | 20 (25·6) |
| Stage II | 16 (66·7) | 24 (66·7) | 64 (62·1) | 51 (65·4) |
| Stage III | 8 (33·3) | 12 (33·3) | 8 (7·8) | 7 (9·0) |
| Previous lines of therapy, median (IQR) | 3 (2–6) | 3 (2–10) | 3 (2–11) | 3 (2–7) |
| Refractory status | ||||
| Relapsed and refractory‡, n (%) | 24 (100) | 36 (100) | 103 (100) | 78 (100) |
| Primary refractory | 0 | 0 | 0 | 0 |
| Relapsed | 0 | 0 | 0 | 0 |
CA, chromosomal abnormalities; d, dexamethasone; ECOG, Eastern Cooperative Oncology Group; Ig, immunoglobulin; IQR, interquartile range; Isa, isatuximab; ISS, international staging system; LDH, lactate dehydrogenase; MM, multiple myeloma; P, pomalidomide; R‐ISS, Revised International Staging System; ULN, upper limit of normal.
*
Other countries: Australia, New Zealand, Turkey and Russia.
†
As per the electronic case report form.
‡
Excluding primary refractory.