Table 2.
Response rates and MRD-negative CR rates among ASCT-ineligible high-risk NDMM patients from MAIA and ALCYONE
| Daratumumab + control | Control | Relative response ratioa(95% CI) | Adjusted ORb(95% CI) | P-value | Sensitivity analysis adjusting for age | ||
|---|---|---|---|---|---|---|---|
| N = 101 | N = 89 | Adjusted ORc(95% CI) | P-value | ||||
| Best response | |||||||
| CR or better (sCR + CR) | 42 (41.6%) | 20 (22.5%) | 1.85 (1.18-2.90) | 2.63 (1.34-5.16) | 0.0051 | 2.57 (1.30-5.06) | .0064 |
| sCR | 27 (26.7%) | 5 (5.6%) | – | – | – | – | – |
| CR | 15 (14.9%) | 15 (16.9%) | – | – | – | – | – |
| MRD-negative CR | 25 (24.8%) | 5 (5.6%) | 4.35 (1.75-10.82) | 5.50 (1.97-15.34) | 0.0011 | 5.31 (1.89-14.88) | .0015 |
| VGPR | 34 (33.7%) | 21 (23.6%) | – | – | – | – | – |
| PR | 17 (16.8%) | 25 (28.1%) | – | – | – | – | – |
| SD | 3 (3.0%) | 19 (21.3%) | – | – | – | – | – |
| PD | 0 (0.0%) | 0 (0.0%) | – | – | – | – | – |
| NE | 5 (5.0%) | 4 (4.5%) | – | – | – | – | – |
| VGPR or better (sCR + CR + VGPR) | 76 (75.2%) | 41 (46.1%) | 1.64 (1.27-2.10) | 4.03 (2.09-7.78) | <0.0001 | 4.08 (2.10-7.91) | <.0001 |
| Overall response (sCR + CR + VGPR + PR) | 93 (92.1%) | 66 (74.2%) | 1.24 (1.08-1.42) | 4.88 (1.94-12.27) | 0.0008 | 4.71 (1.87-11.88) | .0010 |
Relative response ratio was calculated using the Mantel–Haenszel method, with the study identifier as the stratification factor.
Adjusted OR was calculated using stratified logistic regression analysis, with the study identifier as the stratification factor. OR was adjusted for cytogenetic abnormalities [ie, del(17p), t(4, 14), 4(14, 16)], baseline Eastern Cooperative Oncology Group performance status, International Staging System stage, type of multiple myeloma (ie, IgG vs. non-IgG), and renal impairment (defined as creatinine clearance <60 mL/minute).
OR was additionally adjusted for age (<75 vs. ≥75 years).
Abbreviations: ASCT, autologous stem cell transplant; CI, confidence interval; CR, complete response; MRD, minimal residual disease; NDMM, newly diagnosed multiple myeloma; NE, not evaluable; OR, odds ratio; PD, progressive disease; PR, partial response; sCR, stringent complete response; SD, stable disease; VGPR, very good partial response.