MRD status at last follow-up
| MRD-negative (10−5) status* . | D-RVd, n (%) . | RVd, n (%) . | Odds ratio (95% CI)† . | P‡ . |
|---|---|---|---|---|
| Intent-to-treat population | ||||
| MRD-negative | 53/104 (51.0) | 21/103 (20.4) | 4.07 (2.18-7.59) | <.0001 |
| MRD-negative with ≥CR | 49/104 (47.1) | 19/103 (18.4) | 3.89 (2.07-7.33) | <.0001 |
| In patients achieving ≥CR | 49/79 (62.0) | 19/59 (32.2) | 3.57 (1.72-7.44) | .0006 |
| MRD-evaluable population | 53/77 (68.8) | 21/65 (32.3) | 4.47 (2.19-9.11) | <.0001 |
| MRD-negative (10−5) status* . | D-RVd, n (%) . | RVd, n (%) . | Odds ratio (95% CI)† . | P‡ . |
|---|---|---|---|---|
| Intent-to-treat population | ||||
| MRD-negative | 53/104 (51.0) | 21/103 (20.4) | 4.07 (2.18-7.59) | <.0001 |
| MRD-negative with ≥CR | 49/104 (47.1) | 19/103 (18.4) | 3.89 (2.07-7.33) | <.0001 |
| In patients achieving ≥CR | 49/79 (62.0) | 19/59 (32.2) | 3.57 (1.72-7.44) | .0006 |
| MRD-evaluable population | 53/77 (68.8) | 21/65 (32.3) | 4.47 (2.19-9.11) | <.0001 |
MRD data are from last follow-up at a median follow-up of 22.1 months.
The threshold of MRD negativity was defined as 1 tumor cell per 105 white cells. MRD status is based on assessment of bone marrow aspirates by NGS in accordance with IMWG criteria.9 The MRD-evaluable population included patients who had both baseline (with clone identified/calibrated) and postbaseline MRD (with negative, positive, or indeterminate result) samples taken (D-RVd group, n = 77; RVd group, n = 65). Patients with a missing or inconclusive assessment were considered positive for MRD.
Mantel-Haenszel estimate of the common odds ratio for stratified tables is used. The stratification factors are ISS stage (I, II, III) and creatinine clearance (CrCl [30-50 mL/min or > 50 mL/min]) at randomization. An odds ratio >1 indicates an advantage for the daratumumab group.
P values were calculated from the Fisher exact test.