Table 2.
Phase 3 trials with older patients ineligible to receive transplantation
| MAIA DRd∗ | ALCYONE D-VMP† | SWOG VRd‡,§,‖ | ENDURANCE VRd‡ | TOURMALINE IRd¶ |
ENDURANCE KRd‡,¶ | First Rd# | MAIA Rd | SWOG Rd‡,§ | TOURMALINE Rd |
ALCYONE VMP |
CLARION VMP |
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Follow-up (median), mo | 64.5 | 40.1 | 84 | NR | 53.3 | NR | NR | 64.5 | 84 | 55.8 | 40.1 | 22 |
| Number of patients | 368 | 350 | 235 | 542 | 351 | 545 | 535 | 369 | 225 | 354 | 356 | 477 |
| Age (median), y | 73 | 71 | 63 | 64 | 73 | 65 | 73 | 74 | 63 | 74 | 71 | 72 |
| <65 y, % | 1 | 10.3 | 61 | 50 | 3.1 | 50 | 6 | 1 | 53 | 2.3 | 6.7 | 7.3 |
| ≥70 y, % | 78 | NR | NR | 31 | NR | 32 | NR | 80 | NR | NR | NR | NR |
| ≥75 y, % | 43 | 29.7 | NR | NR | 43 | NR | 35 | 44 | NR | 44 | 30.1 | 30.4 |
| ORR, % | 93 | 91 | 90 | 84 | 82 | 87 | 81 | 81 | 79 | 80 | 74 | 79 |
| ≥Complete response, % | 51 | NR | 24 | 15 | 26 | 18 | 22 | 30 | 12 | 14 | NR | 23 |
| Minimal residual disease (10−5) | 32 | 28 | NR | NR | NR | NR | NR | 11 | NR | NR | 7 | 15.5 |
| PFS (median), mo | 61.9 | 36.4 | 34 (>65 y) | 34.4 | 35.3 | 34.6 | 26 | 34.4 | 24 (>65 y) | 21.8 | 19.3 | 22.1 |
| OS (median), mo | NR | NR | 65 (>65 y) | NR | NR | NR | 59 | 65.5 | 56 (>65 y) | NR | NR | NR |
IRd, ixazomib-lenalidomide-dexamethasone; KRd, carfilzomib-lenalidomide-dexamethasone.
DRd, 28-day cycles of IV daratumumab (16 mg/kg once per week during cycles 1-2, once every 2 weeks in cycles 3-6, and once every 4 weeks thereafter) plus lenalidomide (25 mg on days 1-21 of each cycle) and dexamethasone (40 mg on days 1, 8, 15, and 22 of each cycle, with dose reduction to 20 mg if age is >75 years).46,47
D-VMP, 6-week cycles of subcutaneous bortezomib (1.3 mg/m2 of body surface area on days 1, 4, 8, 11, 22, 25, 29, and 32 of cycle 1 and on days 1, 8, 22, and 29 of cycles 2-9), melphalan (9 mg/m2 once daily on days 1-4 of each cycle), and prednisone (60 mg/m2 once daily on days 1-4 of each cycle), IV daratumumab (16 mg/kg once weekly during cycle 1, once every 3 weeks in cycles 2-9, and once every 4 weeks thereafter as maintenance therapy until disease progression).45,57
No intent for immediate transplant.
PFS and OS data from American Society of Hematology 2018 abstract.59
VRd, eight 21-day cycles of IV bortezomib (1.3 mg/m2 of body surface area on days 1, 4, 8, and 11) combined with lenalidomide (25 mg on days 1-14 of each cycle) and dexamethasone (20 mg on days 1, 2, 4, 5, 8, 9, 11, and 12; VRd arm) or Rd alone (six 28-day cycles of lenalidomide 25 mg once a day on days 1-21 and dexamethasone 40 mg on days 1, 8, 15, and 22). On completion of induction, all patients received lenalidomide 25 mg once a day for 21 days plus dexamethasone 40 mg on days 1, 8, 15, and 22 of a 28-day cycle until disease progression.42,43,59
Not approved in first line.
Rd until disease progression.