Table 1.
Demographics and baseline characteristicsa.
| Non-frailb | Frail | |||||||
|---|---|---|---|---|---|---|---|---|
| Fit (19.8%c; n = 146/737) | Intermediate (33.9%c; n = 250/737) | Total–non-frailb (53.7%c; n = 396/737) | Frail (46.3%c; n = 341/737) | |||||
| D-Rd (18.5%d; n = 68/368) | Rd (21.1%e; n = 78/369) | D-Rd (34.8%d; n = 128/368) | Rd (33.1%e; n = 122/369) | D-Rd (53.3%d; n = 196/368) | Rd (54.2%e; n = 200/369) | D-Rd (46.7%d; n = 172/368) | Rd (45.8%e; n = 169/369) | |
| Age, years, n (%) | ||||||||
| Median (range) | 70.0 (65–75) | 71.0 (64–75) | 72.0 (50–80) | 72.0 (61–80) | 71.0 (50–80) | 72.0 (61–80) | 77.0 (57–90) | 77.0 (45–89) |
| <65 | 0 | 2 (2.6) | 2 (1.6) | 1 (0.8) | 2 (1.0) | 3 (1.5) | 2 (1.2) | 1 (0.6) |
| 65–<70 | 27 (39.7) | 26 (33.3) | 29 (22.7) | 27 (22.1) | 56 (28.6) | 53 (26.5) | 18 (10.5) | 20 (11.8) |
| 70–<75 | 36 (52.9) | 44 (56.4) | 62 (48.4) | 62 (50.8) | 98 (50.0) | 106 (53.0) | 32 (18.6) | 25 (14.8) |
| ≥75 | 5 (7.4) | 6 (7.7) | 35 (27.3) | 32 (26.2) | 40 (20.4) | 38 (19.0) | 120 (69.8) | 123 (72.8) |
| ≥80 | 0 | 0 | 6 (4.7) | 4 (3.3) | 6 (3.1) | 4 (2.0) | 60 (34.9) | 67 (39.6) |
| Sex, n (%) | ||||||||
| Female | 37 (54.4) | 31 (39.7) | 63 (49.2) | 64 (52.5) | 100 (51.0) | 95 (47.5) | 79 (45.9) | 79 (46.7) |
| ECOG PS score, n (%) | ||||||||
| 0 | 68 (100.0) | 78 (100.0) | 39 (30.5) | 27 (22.1) | 107 (54.6) | 105 (52.5) | 20 (11.6) | 18 (10.7) |
| 1 | 0 | 0 | 89 (69.5) | 95 (77.9) | 89 (45.4) | 95 (47.5) | 89 (51.7) | 92 (54.4) |
| ≥2 | 0 | 0 | 0 | 0 | 0 | 0 | 63 (36.6) | 59 (34.9) |
| ISS stage, n (%)f | ||||||||
| I | 27 (39.7) | 34 (43.6) | 37 (28.9) | 34 (27.9) | 64 (32.7) | 68 (34.0) | 34 (19.8) | 35 (20.7) |
| II | 27 (39.7) | 31 (39.7) | 62 (48.4) | 58 (47.5) | 89 (45.4) | 89 (44.5) | 74 (43.0) | 67 (39.6) |
| III | 14 (20.6) | 13 (16.7) | 29 (22.7) | 30 (24.6) | 43 (21.9) | 43 (21.5) | 64 (37.2) | 67 (39.6) |
| Type of measurable disease, n (%) | ||||||||
| IgG | 39 (57.4) | 52 (66.7) | 83 (64.8) | 80 (65.6) | 122 (62.2) | 132 (66.0) | 103 (59.9) | 99 (58.6) |
| IgA | 14 (20.6) | 13 (16.7) | 19 (14.8) | 19 (15.6) | 33 (16.8) | 32 (16.0) | 32 (18.6) | 34 (20.1) |
| Otherg | 2 (2.9) | 3 (3.8) | 2 (1.6) | 2 (1.6) | 4 (2.0) | 5 (2.5) | 5 (2.9) | 5 (3.0) |
| Detected in urine only | 8 (11.8) | 5 (6.4) | 13 (10.2) | 14 (11.5) | 21 (10.7) | 19 (9.5) | 19 (11.0) | 15 (8.9) |
| Detected as serum free light chain only | 5 (7.4) | 5 (6.4) | 11 (8.6) | 7 (5.7) | 16 (8.2) | 12 (6.0) | 13 (7.6) | 16 (9.5) |
| CrCl (mL/min), n (%) | ||||||||
| ≥90 | 12 (17.6) | 18 (23.1) | 25 (19.5) | 22 (18.0) | 37 (18.9) | 40 (20.0) | 24 (14.0) | 20 (11.8) |
| 60–<90 | 37 (54.4) | 42 (53.8) | 59 (46.1) | 65 (53.3) | 96 (49.0) | 107 (53.5) | 49 (28.5) | 60 (35.5) |
| 30–<60 | 19 (27.9) | 18 (23.1) | 44 (34.4) | 34 (27.9) | 63 (32.1) | 52 (26.0) | 92 (53.5) | 86 (50.9) |
| <30 | 0 | 0 | 0 | 1 (0.8) | 0 | 1 (0.5) | 7 (4.1) | 3 (1.8) |
| Cytogenetic profileh | ||||||||
| N | 57 | 71 | 109 | 105 | 166 | 176 | 153 | 147 |
| Standard risk, n (%) | 48 (84.2) | 62 (87.3) | 95 (87.2) | 93 (88.6) | 143 (86.1) | 155 (88.1) | 128 (83.7) | 124 (84.4) |
| High risk, n (%)i | 9 (15.8) | 9 (12.7) | 14 (12.8) | 12 (11.4) | 23 (13.9) | 21 (11.9) | 25 (16.3) | 23 (15.6) |
| del17p | 3 (5.3) | 3 (4.2) | 9 (8.3) | 10 (9.5) | 12 (7.2) | 13 (7.4) | 13 (8.5) | 16 (10.9) |
| t(4;14) | 4 (7.0) | 6 (8.5) | 5 (4.6) | 2 (1.9) | 9 (5.4) | 8 (4.5) | 12 (7.8) | 4 (2.7) |
| t(14;16) | 2 (3.5) | 0 | 1 (0.9) | 1 (1.0) | 3 (1.8) | 1 (0.6) | 1 (0.7) | 4 (2.7) |
| Median time since initial diagnosis of MM (range), months | 1.05 (0.2–8.7) | 0.94 (0.2–14.5) | 1.03 (0.1–8.7) | 0.80 (0.2–4.3) | 1.03 (0.1–8.7) | 0.89 (0.2–14.5) | 0.90 (0.2–13.3) | 0.95 (0.0–9.2) |
D-Rd daratumumab plus lenalidomide/dexamethasone, Rd lenalidomide/dexamethasone, ECOG PS Eastern Cooperative Oncology Group performance status, ISS International Staging System, CrCl creatinine clearance, MM multiple myeloma, ITT intent-to-treat.
aPercentages in the table were calculated using the number of patients in each treatment cohort per frailty subgroup of the ITT population (fit: D-Rd, n = 68; Rd, n = 78; intermediate: D-Rd, n = 128; Rd, n = 122; total–non-frail: D-Rd, n = 196; Rd, n = 200; frail: D-Rd, n = 172; Rd, n = 169) as the denominator, unless otherwise indicated.
bNon-frail subgroup consists of fit and intermediate patients.
cPercentage was calculated using the number of patients in the ITT population as the denominator.
dPercentage was calculated using the number of patients in the D-Rd cohort of the ITT population as the denominator.
ePercentage was calculated using the number of patients in the Rd cohort of the ITT population as the denominator.
fBased on the combination of serum β2-microglobulin and albumin.
gIncludes IgD, IgE, IgM, and biclonal.
hCytogenetic risk was based on fluorescence in situ hybridization or karyotype analysis. Percentages were calculated using the number of patients in each treatment cohort per frailty subgroup with available baseline cytogenetic data as the denominator.
iPatients with high-risk cytogenetics had a del17p, t(14;16), or t(4;14) abnormality.