Baseline characteristics of the 818 study patients
| Characteristic . | Maintenance (n = 408) . | No maintenance (n = 410) . |
|---|---|---|
| Age, y | ||
| Median | 65 | 64 |
| Range | 34-89 | 31-86 |
| Sex | ||
| Male | 245 (60.0) | 254 (62.0) |
| Female | 163 (40.0) | 156 (38.0) |
| International Staging System at initial randomization | ||
| I | 88 (21.6) | 90 (22.0) |
| II | 155 (38.0) | 143 (34.9) |
| III | 124 (30.4) | 130 (31.7) |
| Missing data | 41 (10.0) | 47 (11.5) |
| Type of myeloma | ||
| IgG | 240 (58.8) | 245 (59.8) |
| IgA | 106 (26.0) | 91 (22.2) |
| IgM | 1 (0.2) | 3 (0.7) |
| No paraprotein | 5 (1.2) | 9 (2.2) |
| IgD | 12 (2.9) | 6 (1.5) |
| Light chain | 42 (10.3) | 51 (12.4) |
| Missing data | 2 (0.5) | 5 (1.2) |
| Induction treatment pathway | ||
| Intensive | 245 (60.0) | 247 (60.2) |
| Nonintensive | 163 (40.0) | 163 (39.8) |
| Time between initial and maintenance randomization, mo | ||
| Median | 8.3 | 8.2 |
| Range | 3.5-21.7 | 3.9-18.6 |
| Randomized induction chemotherapy regimen | ||
| CVAD | 121 (29.7) | 120 (29.3) |
| CTD | 124 (30.4) | 127 (31.0) |
| MP | 79 (19.4) | 82 (20.0) |
| CTDa | 84 (20.6) | 81 (19.8) |
| Response at maintenance randomization* | ||
| Complete response | 158 (38.7) | 139 (33.9) |
| Very good partial response | 65 (15.9) | 79 (19.3) |
| Partial response | 125 (30.6) | 119 (29.0) |
| Minimal response | 17 (4.2) | 23 (5.6) |
| No change | 10 (2.5) | 24 (5.9) |
| Progressive disease | 9 (2.2) | 14 (3.4) |
| Missing data | 24 (5.9) | 12 (2.9) |
| Interphase cytogenetic abnormalities by iFISH, n/N (%) | ||
| Adverse† | 99/225 (44) | 98/227 (43) |
| gain(1q) | 73/191 (38) | 75/199 (38) |
| del(1p32)‡ | 12/117 (10) | 12/111 (11) |
| t(4;14) | 26/221 (12) | 20/225 (9) |
| t(14;16) | 4/219 (2) | 7/225 (3) |
| t(14;20) | 1/217 (0.5) | 3/223 (1) |
| del(17p) | 17/215 (8) | 11/211 (5) |
| Favorable | 126/225 (56) | 129/227 (57) |
| Characteristic . | Maintenance (n = 408) . | No maintenance (n = 410) . |
|---|---|---|
| Age, y | ||
| Median | 65 | 64 |
| Range | 34-89 | 31-86 |
| Sex | ||
| Male | 245 (60.0) | 254 (62.0) |
| Female | 163 (40.0) | 156 (38.0) |
| International Staging System at initial randomization | ||
| I | 88 (21.6) | 90 (22.0) |
| II | 155 (38.0) | 143 (34.9) |
| III | 124 (30.4) | 130 (31.7) |
| Missing data | 41 (10.0) | 47 (11.5) |
| Type of myeloma | ||
| IgG | 240 (58.8) | 245 (59.8) |
| IgA | 106 (26.0) | 91 (22.2) |
| IgM | 1 (0.2) | 3 (0.7) |
| No paraprotein | 5 (1.2) | 9 (2.2) |
| IgD | 12 (2.9) | 6 (1.5) |
| Light chain | 42 (10.3) | 51 (12.4) |
| Missing data | 2 (0.5) | 5 (1.2) |
| Induction treatment pathway | ||
| Intensive | 245 (60.0) | 247 (60.2) |
| Nonintensive | 163 (40.0) | 163 (39.8) |
| Time between initial and maintenance randomization, mo | ||
| Median | 8.3 | 8.2 |
| Range | 3.5-21.7 | 3.9-18.6 |
| Randomized induction chemotherapy regimen | ||
| CVAD | 121 (29.7) | 120 (29.3) |
| CTD | 124 (30.4) | 127 (31.0) |
| MP | 79 (19.4) | 82 (20.0) |
| CTDa | 84 (20.6) | 81 (19.8) |
| Response at maintenance randomization* | ||
| Complete response | 158 (38.7) | 139 (33.9) |
| Very good partial response | 65 (15.9) | 79 (19.3) |
| Partial response | 125 (30.6) | 119 (29.0) |
| Minimal response | 17 (4.2) | 23 (5.6) |
| No change | 10 (2.5) | 24 (5.9) |
| Progressive disease | 9 (2.2) | 14 (3.4) |
| Missing data | 24 (5.9) | 12 (2.9) |
| Interphase cytogenetic abnormalities by iFISH, n/N (%) | ||
| Adverse† | 99/225 (44) | 98/227 (43) |
| gain(1q) | 73/191 (38) | 75/199 (38) |
| del(1p32)‡ | 12/117 (10) | 12/111 (11) |
| t(4;14) | 26/221 (12) | 20/225 (9) |
| t(14;16) | 4/219 (2) | 7/225 (3) |
| t(14;20) | 1/217 (0.5) | 3/223 (1) |
| del(17p) | 17/215 (8) | 11/211 (5) |
| Favorable | 126/225 (56) | 129/227 (57) |
Data are n (%), unless stated otherwise.
CTD indicates cyclophosphamide, thalidomide, and dexamethasone; CTDa, attenuated CTD; CVAD, cyclophosphamide, vincristine, adriamycin, and dexamethasone; iFISH, interphase fluorescence in situ hybridization; Ig, immunoglobulin; and MP, melphalan and prednisolone.
After induction/high-dose therapy and therefore preceding maintenance randomization.
Multiple abnormalities can be present in the same patient.
Intensive pathway only.