Table 1.
Baseline patient and treatment characteristics.
| Characteristics | S1 (N = 353) | S2 (N = 107) | S3 (N = 141) | p |
|---|---|---|---|---|
| n/% | n/% | n/% | ||
| Sex | ||||
| Male | 205/58.1 | 64/59.8 | 83/58.9 | 0.94 |
| Female | 148/41.9 | 43/40.2 | 58/41.1 | |
| Age in years | ||||
| Median (range) | 54 (32–60) | 63 (61–65) | 68 (66–70) | – |
| WHO performance status | ||||
| 0 | 162/45.9 | 44/41.1 | 46/32.6 | 0.22 |
| 1 | 156/44.2 | 53/49.5 | 76/53.9 | |
| 2 | 25/7.1 | 9/8.4 | 13/9.2 | |
| 3 | 5/1.4 | 1/0.9 | 4/2.8 | |
| Unknown | 5/1.4 | 0/0.0 | 2/1.4 | |
| Heavy chain isotype | ||||
| IgG | 209/59.2 | 65/60.8 | 90/63.8 | 0.53 |
| IgA | 77/21.8 | 17/15.9 | 29/20.6 | |
| LCD | 62/17.6 | 24/22.4 | 19/13.5 | |
| IgD | 5/1.4 | 1/0.9 | 3/2.1 | |
| Light chain isotype | ||||
| Kappa | 233/66.0 | 69/64.5 | 102/72.3 | 0.31 |
| Lambda | 120/34.0 | 38/35.5 | 39/27.7 | |
| Calcium elevation (calcium > 2.65 mmol/l) | ||||
| Yes | 45/12.8 | 17/15.9 | 18/12.8 | 0.68 |
| Renal insufficiency (creatinine > 177 μmol/l) | ||||
| Yes | 44/12.5 | 17/15.9 | 22/15.6 | 0.54 |
| Anemia (Hb < 10 g/dl or 2 g/dl < normal) | ||||
| Yes | 179/50.7 | 55/51.4 | 78/55.3 | 0.65 |
| Bone disease (lytic lesionsa) | ||||
| Yes | 316/89.5 | 99/92.5 | 127/90.1 | 0.69 |
| ISS stage | ||||
| I | 145/41.1 | 44/41.1 | 41/29.1 | 0.04 |
| II | 122/34.6 | 29/27.1 | 55/39.0 | |
| III | 86/24.4 | 34/31.8 | 45/31.9 | |
| Revised ISS stage | ||||
| I | 85/27.4 | 33/35.1 | 30/22.7 | 0.15 |
| II | 184/59.4 | 46/48.9 | 87/65.9 | |
| III | 41/13.2 | 15/16.0 | 15/11.4 | |
| Adverse cytogenetics | ||||
| del 17p13 | ||||
| done | 321 | 93 | 135 | 0.40 |
| positive (% of done) | 42/13.1 | 8/8.6 | 13/9.6 | |
| t (4;14) | ||||
| done | 316 | 94 | 134 | 0.10 |
| positive (% of done) | 39/12.3 | 6/6.4 | 9/6.7 | |
| gain 1q21 (>3 copies) | ||||
| done | 310 | 92 | 134 | 0.56 |
| positive (% of done) | 30/9.7 | 8/8.7 | 17/12.7 | |
| t (14;16) | ||||
| done | 306 | 93 | 131 | 0.88 |
| positive (% of done) | 10/3.3 | 2/2.1 | 3/2.3 | |
| anyb | ||||
| done | 301 | 90 | 132 | 0.21 |
| positive (% of done) | 96/31.9 | 20/22.2 | 36/27.3 | |
| LDH (serum) | ||||
| ≤ULN | 298/84.4 | 89/84.0 | 122/87.1 | 0.71 |
| >ULN | 55/15.6 | 17/16.0 | 18/12.9 | |
| Glomerular filtration rate (serum, ml/min) | ||||
| Median (range) | 104 (6–232) | 82 (14–154) | 76 (14–152) | <0.001 |
| Any previous/concomitant disease | ||||
| Yes | 317/89.8 | 100/93.5 | 136/96.5 | 0.04 |
| Cardiac and vascular disorders | ||||
| 0–1 | 315/89.2 | 78/72.9 | 100/70.9 | <0.001 |
| >1 | 38/10.8 | 29/27.1 | 41/29.1 | |
| Induction therapy (assigned by randomization) | ||||
| PAd | 174/49.3 | 46/43.0 | 79/56.0 | 0.11 |
| VCD | 179/50.7 | 61/57.0 | 62/44.0 | |
| Maintenance therapy strategy (assigned by randomization) | ||||
| LEN-2Y | 169/47.9 | 58/54.2 | 73/51.8 | 0.46 |
| LEN-CR | 184/52.1 | 49/45.8 | 68/48.2 | |
Bold p values depict a statistically significant result.
ISS International Staging System, WHO World Health Organization, LDH lactate dehydrogenase, >ULN greater than the upper level of normal range, LCD light chain disease, IgG/A immunoglobulin G/A, hb hemoglobin, LEN lenalidomide, PAd bortezomib/doxorubicine/dexamethasone induction therapy, VCD bortezomib, cyclophosphamide, dexamethasone induction therapy, LEN-2Y (study arms A1 + A2) continuous lenalidomide maintenance for 2 years, LEN-CR (study arms B1 + B2) lenalidomide maintenance for 2 years, if no complete response (CR) was achieved.
aor myeloma-related osteopenia/osteoporosis.
bat least one high-risk aberration, including del 17p13, t (4;14), t(14;16) or gain 1q21 > 3 copies. ISS and revised ISS were calculated according to Greipp et al. [25] and Palumbo et al. [26].