Patient demographic and disease characteristics in the intent-to-treat population at baseline
| . | D-RVd . | RVd . |
|---|---|---|
| Age, y | n = 104 | n = 103 |
| Median (range) | 59 (29-70) | 61 (40-70) |
| Category, n (%) | ||
| <65 | 76 (73.1) | 75 (72.8) |
| ≥65 | 28 (26.9) | 28 (27.2) |
| Sex, n (%) | n = 104 | n = 103 |
| Male | 58 (55.8) | 60 (58.3) |
| Female | 46 (44.2) | 43 (41.7) |
| ECOG performance status, n (%)* | n = 101 | n = 102 |
| 0 | 39 (38.6) | 40 (39.2) |
| 1 | 51 (50.5) | 52 (51.0) |
| 2 | 11 (10.9) | 10 (9.8) |
| ISS disease stage, n (%)† | n = 104 | n = 103 |
| I | 49 (47.1) | 50 (48.5) |
| II | 40 (38.5) | 37 (35.9) |
| III | 14 (13.5) | 14 (13.6) |
| Missing | 1 (1.0) | 2 (1.9) |
| Baseline creatinine clearance, mL/min, n (%) | n = 104 | n = 103 |
| 30-50 | 9 (8.7) | 9 (8.7) |
| >50 | 95 (91.3) | 94 (91.3) |
| Cytogenetic risk profile, n (%)‡ | n = 98 | n = 97 |
| Standard | 82 (83.7) | 83 (85.6) |
| High risk | 16 (16.3) | 14 (14.4) |
| Time since diagnosis of MM, mo | n = 103 | n = 102 |
| Median (range) | 0.7 (0-12) | 0.9 (0-61) |
| . | D-RVd . | RVd . |
|---|---|---|
| Age, y | n = 104 | n = 103 |
| Median (range) | 59 (29-70) | 61 (40-70) |
| Category, n (%) | ||
| <65 | 76 (73.1) | 75 (72.8) |
| ≥65 | 28 (26.9) | 28 (27.2) |
| Sex, n (%) | n = 104 | n = 103 |
| Male | 58 (55.8) | 60 (58.3) |
| Female | 46 (44.2) | 43 (41.7) |
| ECOG performance status, n (%)* | n = 101 | n = 102 |
| 0 | 39 (38.6) | 40 (39.2) |
| 1 | 51 (50.5) | 52 (51.0) |
| 2 | 11 (10.9) | 10 (9.8) |
| ISS disease stage, n (%)† | n = 104 | n = 103 |
| I | 49 (47.1) | 50 (48.5) |
| II | 40 (38.5) | 37 (35.9) |
| III | 14 (13.5) | 14 (13.6) |
| Missing | 1 (1.0) | 2 (1.9) |
| Baseline creatinine clearance, mL/min, n (%) | n = 104 | n = 103 |
| 30-50 | 9 (8.7) | 9 (8.7) |
| >50 | 95 (91.3) | 94 (91.3) |
| Cytogenetic risk profile, n (%)‡ | n = 98 | n = 97 |
| Standard | 82 (83.7) | 83 (85.6) |
| High risk | 16 (16.3) | 14 (14.4) |
| Time since diagnosis of MM, mo | n = 103 | n = 102 |
| Median (range) | 0.7 (0-12) | 0.9 (0-61) |
The intent-to-treat population was defined as all randomized patients. Informal testing showed no differences between the 2 treatment groups in the characteristics evaluated at baseline.
ECOG performance status is scored on a scale from 0 to 5, with 0 indicating no symptoms and higher scores indicating increasing disability.
The ISS disease stage is based on the combination of serum β2-microglobulin and albumin levels. Higher stages indicate more advanced disease.
Cytogenetic risk was assessed by FISH (local testing); high risk was defined as the presence of del17p, t(4;14), or t(14;16) among patients with available cytogenetic risk data.