TABLE 4.
Comparison between phase 1 and phase 2 clinical trial and study cohort
| DREAMM1 11 | DREAMM2 12 | Real‐world a | ||
|---|---|---|---|---|
| 2.5 mg/kg | 3.4 mg/kg | |||
| Patients, n | 35 | 97 | 96 | 106 |
| Age, years; median (range) | 60 (46–75) | 65 (60–70) | 67 (61–72) | 69 (36–88) |
| >75 years, n (%) | NR | 13 (13) | 17 (17) | 24 (23) |
| ISS 1/2/3, % | 54/17/11 | 22/34/43 | 18/51/30 | 43/30/26 |
| High‐risk cytogenetics, n(%) | ||||
| del17p | 6 (17) | 16 (16) | 22 (22) | 12 (19) |
| t 4;14 | 3 (9) | 11 (11) | 11 (11) | 1 (1.6) |
| t 14;16 | 1 (3) | 7 (7) | 2 (2) | 1 (1.6) |
| +1q gain/amp | 3 (9) | 25 (26) | 30 (30) | 18 (28) |
| Extra‐medullary disease | NR | 22 (23) | 18 (18) | 12 (21) |
| Number of previous lines, n (range) | 5 (1–10+) | 7 (3–21) | 6 (3–21) | 6 (2–11) |
| Exposure/refractoriness to anti‐myeloma drugs; (%/%) | ||||
| PIs | ||||
| Bortezomib | 100/97 | 98/76 | 98/75 | 97/58 |
| Carfilzomib | NR | 76/65 | 65/58 | 72/64 |
| IMiDs | ||||
| Lenalidomide | 83/77 | 100/90 | 100/89 | 92/74 |
| Pomalidomide | 100/94 | 92/87 | 85/78 | 77/63 |
| Daratumumab | NR | 100/100 | 97/92 | 95/80 |
| Triple refractory, % | 63/63 | 100 | 100 | 73 |
| Penta‐refractory, n (%) | 40/40 | 32 | ||
Abbreviations: IMiD, immunomodulatory drug; ISS, international staging system; NR, not reached; PI, proteasome inhibitor.
a
Percentages in real‐world cohort are computed from number of patients with available data.