Table 2.
Minimal residual disease negativity.
| Study | Regimen | Sample Size | MRD Availability | MRD Negativitya | MRD Negativityb Rate (95% CI) |
|---|---|---|---|---|---|
| IFM/DFCI 200949 | — RVD + ASCT RVD |
700 350 350 |
581 (at least VGPR) 308 273 |
423 246 177 |
0.60 (0.57, 0.64) 0.70 (0.65, 0.75) 0.51 (0.45, 0.56) |
| GEM2005MAS6534 | — VMP VTP |
260 130 130 |
153 (at least PR) 79 74 |
34 19 15 |
0.13 (0.09, 0.18) 0.15 (0.09, 0.22) 0.12 (0.07, 0.18) |
| NCT0053145346 | — VTDC VTD |
98 49 49 |
58 (suspected CR) 26 32 |
42 16 26 |
0.43 (0.33, 0.53) 0.33 (0.2, 0.48) 0.53 (0.38, 0.67) |
| ALCYONE47 | — Dara+VMP VMP |
706 350 356 |
236 (at CR or sCR) 149 87 |
100 78 22 |
0.14 (0.12, 0.17) 0.22 (0.18, 0.27) 0.06 (0.04, 0.09) |
| EMN02/HO9550, 51 | — ASCT VMP |
1192 695 497 |
957 (at least VGPR) 584 373 |
814 449 274 |
0.68 (0.66, 0.71) 0.65 (0.61, 0.68) 0.55 (0.50, 0.59) |
| CLARION | — KMP VMP |
327 166 161 |
223 (EOT) 113 110 |
65 33 32 |
0.20 (0.14, 0.27) 0.20 (0.14, 0.27) 0.20 (0.14, 0.27) |
ASCT, autologous stem cell transplant; CI, confidence interval; CR, complete response; Dara, daratumumab; EOT, end of treatment; KMP, carfilzomib, melphalan, and prednisone; MRD, minimal residual disease; PFS, progression-free survival; PR, partial response; RVD, lenalidomide, bortezomib, and dexamethasone; VGPR, very good partial response; VMP, bortezomib, melphalan, and prednisone; sCR, stringent complete response; VTD, bortezomib, thalidomide, and dexamethasone; VTDC, bortezomib, thalidomide, dexamethasone, and cyclophosphamide; VTP, bortezomib, thalidomide, and prednisone
MRD negativity was calculated based on the sample size assuming those patients without an MRD status were MRD positive.
MRD-negativity rate is presented as the number of MRD-negative patients divided by the total number of patients in the trial arm (sample size).