Primary analysis: summary of responses by the end of consolidation
| . | D-RVd, n (%) . | RVd, n (%) . | Odds ratio (95% CI)* . | P . |
|---|---|---|---|---|
| Best response† | n = 99 | n = 97 | ||
| ORR | 98 (99.0) | 89 (91.8) | 8.75 (1.08, 71.01) | .0160‡ |
| sCR | 42 (42.4) | 31 (32.0) | 1.57 (0.87, 2.82) | .0680‡,§ |
| ≥CR | 51 (51.5) | 41 (42.3) | ||
| CR | 9 (9.1) | 10 (10.3) | ||
| ≥VGPR | 90 (90.9) | 71 (73.2) | 3.53 (1.55, 8.00) | .0014‡ |
| VGPR | 39 (39.4) | 30 (30.9) | ||
| PR | 8 (8.1) | 18 (18.6) | ||
| SD | 1 (1.0) | 7 (7.2) | ||
| PD | 0 | 1 (1.0) |
| . | D-RVd, n (%) . | RVd, n (%) . | Odds ratio (95% CI)* . | P . |
|---|---|---|---|---|
| Best response† | n = 99 | n = 97 | ||
| ORR | 98 (99.0) | 89 (91.8) | 8.75 (1.08, 71.01) | .0160‡ |
| sCR | 42 (42.4) | 31 (32.0) | 1.57 (0.87, 2.82) | .0680‡,§ |
| ≥CR | 51 (51.5) | 41 (42.3) | ||
| CR | 9 (9.1) | 10 (10.3) | ||
| ≥VGPR | 90 (90.9) | 71 (73.2) | 3.53 (1.55, 8.00) | .0014‡ |
| VGPR | 39 (39.4) | 30 (30.9) | ||
| PR | 8 (8.1) | 18 (18.6) | ||
| SD | 1 (1.0) | 7 (7.2) | ||
| PD | 0 | 1 (1.0) |
The primary analysis occurred on 25 January 2019 (median follow-up, 13.5 months) after all randomized patients completed the post-ASCT disease evaluation or discontinued from study treatment by this time point.
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.
Responses were assessed according to the IMWG recommendations by computer algorithm (details on the response criteria are provided in supplemental Table 1). This analysis included all patients in the response-evaluable population of all randomized patients who had a confirmed diagnosis of MM, measurable disease at baseline, received ≥1 dose of study treatment, and had ≥1 postbaseline disease assessment.
P values were calculated with the use of the Cochran-Mantel-Haenszel χ2 test.
A 1-sided P value is reported for the primary end point (postconsolidation sCR); all other responses were calculated using a 2-sided P value not adjusted for multiplicity.