Table I.
Cytogenetic risk in the ITT population at baseline, n (%) | Isa–Pd (n = 154) | Pd (n = 153) |
---|---|---|
Standard‐risk | 103 (66·9) | 78 (51·0) |
High‐risk | 24 (15·6) | 36 (23·5) |
del(17p) | 14 (9·1) | 23 (15·0) |
t(4;14) | 12 (7·8) | 14 (9·2) |
t(14;16) | 1 (0·6) | 4 (2·6) |
del(17p) and t(4;14) | 3 (1·9) | 4 (2·6) |
del(17p) and t(14;16) | 0 | 1 (0·7) |
Unknown/missing | 27 (17·5) | 39 (25·5) |
1q21, regardless of other high‐risk cytogenetic abnormalities | ||
Gain(1q21), ≥3 copies | 76 (49·4) | 52 (34·0) |
Amplification 1q21, ≥4 copies | 27 (17·5) | 21 (13·7) |
Isolated 1q21, without other high‐risk cytogenetic abnormalities | ||
Gain(1q21), ≥3 copies | 56 (36·4) | 29 (19·0) |
Amplification 1q21, ≥4 copies | 23 (14·9) | 9 (5·9) |
High‐risk cytogenetics was prespecified as ≥1 of: del(17p) 50% cut‐off, t(4;14) 30% cut‐off, t(14;16) 30% cut‐off. The cut‐off for gain(1q21) and amplification 1q21 was 30%.
d, dexamethasone; Isa, isatuximab; ITT, intent‐to‐treat; P, pomalidomide.