Page 229 - Haematologica Vol. 109 - July 2024
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ARTICLE - ICARIA-MM final overall survival analysis P.G. Richardson et al. Table 1. Baseline demographic and patient characteristics of the intention-to-treat population.
 Characteristic
  Isa-Pd N=154
  Pd N=153
  Age in years Median (IQR) <65, N (%) 65–75, N (%) ≥75, N (%)
  68 (60-74) 54 (35) 68 (44) 32 (21)
 66 (59-71) 70 (46) 54 (35) 29 (19)
 Sex, N (%) Female Male
  65 (42) 89 (58)
  83 (54) 70 (46)
  Ethnicity, N (%) Hispanic or Latino
Not Hispanic or Latino Unknown
Not reported
  4 (3) 130 (84) 2 (1) 18 (12)
 3 (2) 134 (88) 2 (1) 14 (9)
 History of asthma or COPD, N (%)
 16 (10)
 17 (11)
 eGFR <60 mL/min/1.73 m2, N/N (%)
 55/142 (39)
 49/145 (34)
 Previous autologous stem-cell transplantation, N (%)
  83 (54)
  90 (59)
 Time since initial diagnosis in years, median (IQR)
 4.5 (2.6-7.2)
 4.1 (2.9-7.0)
  Type of myeloma at diagnosis, N (%) IgA
IgG
Light chain (κ+λ) Other
  34 (22) 102 (66) 15 (10) 2 (1)
 41 (27) 100 (65) 11 (7) 0
  ISS stage at study entry, N (%) Stage I
Stage II
Stage III
Unknown
 64 (42) 53 (34) 34 (22) 3 (2)
  51 (33) 56 (37) 43 (28) 3 (2)
  Cytogenetic risk at baseline,a N (%) High
Standard Missing
 24 (16) 103 (67) 27 (18)
  36 (24) 78 (51) 39 (25)
 Number of previous lines of therapy, median (IQR)
  3 (2-4)
  3 (2-4)
  Previous therapy, N (%) Alkylating agent Proteasome inhibitors Immunomodulatory agents
   139 (90) 154 (100) 154 (100)
  148 (97) 153 (100) 153 (100)
  Refractory to treatment, N (%) Last line of therapy Immunomodulatory agent Lenalidomide
Proteasome inhibitor
Lenalidomide and proteasome inhibitor Lenalidomide last line
   150 (97) 147 (95) 144 (94) 118 (77) 111 (72) 93 (60)
  151 (99) 144 (94) 140 (92) 115 (75) 107 (70) 88 (58)
   Cytogenetic analysis was performed by fluorescence in situ hybridization by a central laboratory with cutoff of 50% for del(17p) and 30% for t(4;14) and t(14;16). aHigh-risk cytogenetic status was defined as the presence of at least del(17p), t(4;14), or t(14;16) chromosomal abnormal- ities. COPD: chronic obstructive pulmonary disease; eGFR: estimated glomerular filtration rate; IgA: immunoglobulin A; IgG: immunoglobulin G; Isa-Pd: isatuximab-pomalidomide-dexamethasone; ISS: International Staging System (ISS staging is derived based on the combination of serum b2-microglobulin and albumin); Pd: pomalidomide-dexamethasone.
± steroids (Online Supplementary Figure S4). Some patients receiving daratumumab, alone or in combination, as a first subsequent line of therapy achieved ≥VGPR, even after re- ceiving prior isatuximab study therapy (2/8 patients [25%]) with a short washout period (median, 13 days) (Figure 4).
Among patients receiving non-daratumumab–based ther- apy, median PFS on the first line of subsequent therapy was similar in the Isa-Pd group (4.6 months, 95% CI: 3.1-6.6 in 69/93 [74%] patients receiving subsequent non-dara- tumumab therapy) versus the Pd group (5.2 months, 95%
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