Table 1 Patient demographics and baseline disease characteristics.
Ixa-dex N = 73 | Pom-dex N = 49 | |
|---|---|---|
Median age (range), years | 72 (42–86) | 68 (39–83) |
Age categories, n (%) | ||
<65 yearsa | 18 (25) | 13 (27) |
≥65 yearsa | 55 (75) | 36 (73) |
≥65–<75 years | 29 (40) | 27 (55) |
≥75–<85 years | 23 (32) | 9 (18) |
≥85 years | 3 (4) | 0 |
Sex, n (%) | ||
Male | 35 (48) | 26 (53) |
Female | 38 (52) | 23 (47) |
Race, n (%) | ||
White | 69 (95) | 46 (94) |
Asian | 1 (1) | 0 |
Black or African American | 1 (1) | 0 |
Not reported | 2 (3) | 3 (6) |
ECOG performance status at baseline, n (%) | ||
0 | 28 (38) | 21 (43) |
1 | 38 (52) | 23 (47) |
2 | 7 (10) | 5 (10) |
ISS stage at study entry,a n (%) | ||
I or II | 55 (75) | 38 (78) |
III | 18 (25) | 11 (22) |
Creatinine clearance, n (%) | ||
≥30–<60 mL/min | 21 (29) | 12 (24) |
≥60 mL/min | 27 (37) | 15 (31) |
≥90 mL/min | 19 (26) | 10 (20) |
Missing | 6 (8) | 12 (24) |
LDH status, n (%) | ||
Elevated | 13 (18) | 9 (18) |
Normal | 59 (81) | 40 (82) |
Missing | 1 (1) | 0 |
Median time from initial diagnosis to first dose of study treatment, months (range) | 67.2 (22–169) | 58.6 (6–274) |
Number of prior lines of therapy,a n (%) | ||
2 | 35 (48) | 23 (47) |
≥3 | 38 (52) | 26 (53) |
Relapsed and/or refractory status to prior systemic therapy, n (%) | ||
Relapsed | 2 (3) | 2 (4) |
Refractory | 16 (22) | 11 (22) |
Relapsed and refractory | 55 (75) | 36 (73) |
Prior lines of therapy received, n (%) | ||
Bortezomib | 73 (100) | 49 (100) |
Lenalidomide | 73 (100) | 49 (100) |
Thalidomide | 23 (32) | 10 (20) |
Daratumumab | 14 (19) | 7 (14) |
Carfilzomib | 7 (10) | 1 (2) |
Prior transplant, n (%) | 32 (44) | 28 (57) |