Comparison of ALCYONE and MAIA studies
| . | ALCYONE1,2,11 . | MAIA3,4,20 . | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All patients . | Age <75 y . | Age ≥75 y . | All patients . | Age <75 y . | Age ≥75 y . | |||||||
| D-VMP . | VMP . | D-VMP . | VMP . | D-VMP . | VMP . | D-Rd . | Rd . | D-Rd . | Rd . | D-Rd . | Rd . | |
| No. of patients | 350 | 356 | 246 | 249 | 104 | 107 | 368 | 369 | 208 | 208 | 160 | 161 |
| Median follow-up, mo | 40.1* | 40.1* | 40.1* | 36.4† | 36.4† | 36.4† | ||||||
| PR or better (%) | 90.9 | 73.9 | 92.3 | 75.5 | 87.5 | 70.1 | 93 | 82 | 95 | 82 | 90 | 81 |
| CR or sCR (%) | 46 | 25 | 48 | 26 | 41 | 24 | 50 | 27 | 52 | 25 | 41 | 25 |
| MRD negativity (10−5) (%) | 28 | 7 | 22 | 6 | 24 | 8 | 29 | 9 | 27.9 | 7.2 | 19.4 | 7.5 |
| PFS | ||||||||||||
| HR | 0.42 | 0.49 | 0.53 | 0.56 | 0.49 | 0.62 | ||||||
| 95% CI | 0.34-0.51 | 0.36-0.68 | 0.32-0.85 | 0.44-0.71 | 0.35-0.69 | 0.44-0.87 | ||||||
| OS | ||||||||||||
| HR | 0.61 | 0.56 | 0.71 | NR | NR | NR | ||||||
| 95% CI | 0.46-0.80 | 0.40-0.79 | 0.44-1.13 | |||||||||
| Grade ≥3 (%) | ||||||||||||
| Neutropenia | 40 | 39 | 35 | 38 | 52 | 42 | 51 | 35 | 43 | 31 | 60 | 41 |
| Infections | 23 | 15 | 21 | 13 | 28 | 20 | 36 | 27 | 32 | 23 | 33 | 24 |
| Infusion-related reactions (all grade) (%) | 27.7 | NA | 24 | NA | 36 | NA | 40.9 | NA | 44.9 | NA | 35.7 | NA |
| . | ALCYONE1,2,11 . | MAIA3,4,20 . | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All patients . | Age <75 y . | Age ≥75 y . | All patients . | Age <75 y . | Age ≥75 y . | |||||||
| D-VMP . | VMP . | D-VMP . | VMP . | D-VMP . | VMP . | D-Rd . | Rd . | D-Rd . | Rd . | D-Rd . | Rd . | |
| No. of patients | 350 | 356 | 246 | 249 | 104 | 107 | 368 | 369 | 208 | 208 | 160 | 161 |
| Median follow-up, mo | 40.1* | 40.1* | 40.1* | 36.4† | 36.4† | 36.4† | ||||||
| PR or better (%) | 90.9 | 73.9 | 92.3 | 75.5 | 87.5 | 70.1 | 93 | 82 | 95 | 82 | 90 | 81 |
| CR or sCR (%) | 46 | 25 | 48 | 26 | 41 | 24 | 50 | 27 | 52 | 25 | 41 | 25 |
| MRD negativity (10−5) (%) | 28 | 7 | 22 | 6 | 24 | 8 | 29 | 9 | 27.9 | 7.2 | 19.4 | 7.5 |
| PFS | ||||||||||||
| HR | 0.42 | 0.49 | 0.53 | 0.56 | 0.49 | 0.62 | ||||||
| 95% CI | 0.34-0.51 | 0.36-0.68 | 0.32-0.85 | 0.44-0.71 | 0.35-0.69 | 0.44-0.87 | ||||||
| OS | ||||||||||||
| HR | 0.61 | 0.56 | 0.71 | NR | NR | NR | ||||||
| 95% CI | 0.46-0.80 | 0.40-0.79 | 0.44-1.13 | |||||||||
| Grade ≥3 (%) | ||||||||||||
| Neutropenia | 40 | 39 | 35 | 38 | 52 | 42 | 51 | 35 | 43 | 31 | 60 | 41 |
| Infections | 23 | 15 | 21 | 13 | 28 | 20 | 36 | 27 | 32 | 23 | 33 | 24 |
| Infusion-related reactions (all grade) (%) | 27.7 | NA | 24 | NA | 36 | NA | 40.9 | NA | 44.9 | NA | 35.7 | NA |
Patient population: NDMM, ineligible for transplant; Eastern Cooperative Oncology Group performance status, 0-2; creatinine clearance, ≥40 mL/min in ALCYONE and ≥30 mL/min in MAIA.
HR, hazard ratio; NA, not applicable; NR, not reported; PR, partial response; sCR, stringent complete response.
PFS and MRD data for the subgroups and toxicity data are based on the analysis with a follow-up of 16.5 months.2
Response and toxicity data for the subgroups is based on the analysis with follow-up of 28.0 months.20