Table 1.
Baseline demographics and disease characteristics in patients with RRMM included in the full analysis set
| N = 295 | |
|---|---|
| Age, median (range), years | 74 (43–90) |
| ≤ 65, n (%) | 59 (20.0) |
| > 65 to ≤ 75, n (%) | 122 (41.4) |
| > 75, n (%) | 114 (38.6) |
| Male sex, n (%) | 168 (56.9) |
| Type of myeloma, n (%) | |
| IgG type | 150 (50.8) |
| IgA type | 69 (23.4) |
| Bence Jones type | 62 (21.0) |
| Other | 14 (4.7) |
| Time since initial diagnosis, median (range), months | 35.0 (0.6–240.2) |
| ECOG performance status, n (%) | |
| 0 or 1 | 237 (80.3) |
| 2 | 23 (7.8) |
| ≥ 3 | 23 (7.8) |
| Missing | 12 (4.1) |
| ISS stage (at IRd initiation), n (%) | |
| Stage I or II | 208 (70.5) |
| Stage III | 31 (10.5) |
| Missing | 56 (19.0) |
| Creatinine clearance, mL/min, n (%) | |
| < 60 | 110 (37.3) |
| ≥ 60 | 167 (56.6) |
| Missing | 18 (6.1) |
| IMWG frailty score, n (%)a | |
| Frail | 84 (28.5) |
| Intermediate fitness | 72 (24.4) |
| Fit | 124 (42.0) |
| Missing | 15 (5.1) |
| Disease status, n (%) | |
| Clinical relapseb | 69 (23.4) |
| Paraprotein relapsec | 156 (52.9) |
| Other | 70 (23.7) |
| Cytogenetic risk, n (%)d | |
| High-riske | 68 (23.1) |
| Standard riskf | 156 (52.9) |
| Expanded high-riskg | 148 (50.2) |
| Modified standard riskh | 76 (25.8) |
| Missing | 71 (24.1) |
| Prior treatment regimens, median (range), months | 2.0 (1.0–12.0) |
| 1, n (%) | 90 (30.5) |
| 2, n (%) | 81 (27.5) |
| 3, n (%) | 63 (21.4) |
| ≥ 4, n (%) | 61 (20.7) |
| Prior stem cell transplant, n (%) | 91 (30.8) |
| Prior proteasome inhibitor therapy, n (%) | |
| Bortezomib | 226 (76.6) |
| Carfilzomib | 38 (12.9) |
| Prior immunomodulatory drug therapy, n (%) | |
| Lenalidomide | 244 (82.7) |
| Pomalidomide | 38 (12.9) |
| Prior daratumumab therapy, n (%) | 26 (8.8) |
ECOG Eastern Cooperative Oncology Group, Ig immunoglobulin, IMWG International Myeloma Working Group, IRd ixazomib + lenalidomide + dexamethasone, ISS International Staging System, RRMM relapsed/refractory multiple myeloma, SD standard deviation
aPatients were assessed on the activities of daily living and instrumental activities of daily living items on the IMWG frailty scale; Charlson Comorbidity Index items were also assessed
bClinical relapse was defined as disease recurrence with CRAB (i.e., calcium elevation, renal insufficiency, anemia, and bone abnormalities) symptoms
cParaprotein relapse was defined as disease recurrence with elevated M-protein levels but without CRAB symptoms
dCut-off levels were 5% positive cells for del(17p)) and 3% for t(4;14), t(11;14), t(14;16), and 1q21 gain
eHigh-risk was defined as the presence of ≥ 1 of t(4;14), t(14;16), or del(17p)
fStandard risk was defined as the absence of high-risk cytogenetic abnormalities
gExpanded high-risk was defined as the presence of ≥ 1 of t(4;14), t(14;16), or del(17p) and/or 1q21 gain
hModified standard risk was defined as the absence of expanded high-risk cytogenetic abnormalities