Patient and disease characteristics (intention-to-treat population)
| . | Transplant arm (n = 139) . | Control arm (n = 138) . |
|---|---|---|
| Age, y | 61.3 (29.9-74.7) | 62.2 (41.9-74.5) |
| Interval diagnosis to randomization, y | 3.9 (0.2-19.3) | 4.1 (0.7-16.4) |
| Sex | ||
| Female | 60 (43%) | 54 (39%) |
| Male | 79 (57%) | 84 (61%) |
| WHO PS | ||
| 0 | 96 (69%) | 105 (76%) |
| 1 | 43 (31%) | 32 (23%) |
| 2 | 0 | 1 (1%) |
| ISS stage∗ | ||
| I | 82/131 (63%) | 77/129 (60%) |
| II | 32/131 (24%) | 40/129 (31%) |
| III | 17/131 (13%) | 12/129 (9%) |
| Heavy chain isotype | ||
| IgG | 79 (57%) | 71 (52%) |
| IgA | 33 (24%) | 33 (24%) |
| IgD | 1 (1%) | 0 |
| Light chain myeloma | 26 (19%) | 33 (24%) |
| Light chain isotype | ||
| κ | 87 (63%) | 102 (75%) |
| λ | 52 (37%) | 35 (26%) |
| Cytogenetic aberrations∗ | ||
| t(4;14) | 19/94 (20%) | 10/99 (10%) |
| t(11;14) | 17/88 (19%) | 20/96 (21%) |
| t(14;16) | 2/90 (2%) | 0/97 |
| del13q14 | 59/97 (61%) | 45/104 (43%) |
| del17p13 | 14/98 (14%) | 15/107 (14%) |
| Gain1q (>3 copies) | 11/97 (11%) | 12/105 (11%) |
| High risk† | 39/91 (43%) | 31/98 (32%) |
| Standard risk | 52/91 (57%) | 67/98 (68%) |
| LDH | ||
| Normal | 115 (83%) | 114 (83%) |
| Elevated | 24 (17%) | 24 (17%) |
| eGFR | ||
| ≥60 mL/min per 1.73 m2 | 108 (82%) | 106 (79%) |
| <60 mL/min per 1.73 m2 | 23 (18%) | 28 (21%) |
| Prior lines of therapy | ||
| 1 | 131 (94%) | 129 (94%) |
| 2 | 5 (4%) | 8 (6%) |
| 3 | 3 (2%) | 1 (1%) |
| Frontline HDCT/ASCT | 129 (93%) | 130 (94%) |
| Single | 83 (64%) | 71 (55%) |
| Tandem | 46 (36%) | 59 (45%) |
| TTP1, mo‡ | 34.3 (12.3-136.8) | 31.3 (12.1-131) |
| 12-24 | 44 (34%) | 47 (36%) |
| 24-48 | 42 (33%) | 51 (39%) |
| >48 | 43 (33%) | 32 (25%) |
| Prior therapies | ||
| Bortezomib | 107 (77%) | 106 (77%) |
| Thalidomide | 31 (22%) | 25 (18%) |
| Lenalidomide | 12 (9%) | 18 (13%) |
| Interferon | 9 (6%) | 9 (7%) |
| Chemotherapy only | 14 (10%) | 10 (7%) |
| Prior maintenance therapies | ||
| Any | 46 (33%) | 50 (36%) |
| Thalidomide | 25 (18%) | 19 (14%) |
| Interferon | 9 (6%) | 9 (7%) |
| Lenalidomide | 6 (4%) | 10 (7%) |
| Bortezomib | 5 (4%) | 12 (9%) |
| Ixazomib | 4 (3%) | 2 (1%) |
| Dexamethasone | 1 (1%) | 2 (1%) |
| . | Transplant arm (n = 139) . | Control arm (n = 138) . |
|---|---|---|
| Age, y | 61.3 (29.9-74.7) | 62.2 (41.9-74.5) |
| Interval diagnosis to randomization, y | 3.9 (0.2-19.3) | 4.1 (0.7-16.4) |
| Sex | ||
| Female | 60 (43%) | 54 (39%) |
| Male | 79 (57%) | 84 (61%) |
| WHO PS | ||
| 0 | 96 (69%) | 105 (76%) |
| 1 | 43 (31%) | 32 (23%) |
| 2 | 0 | 1 (1%) |
| ISS stage∗ | ||
| I | 82/131 (63%) | 77/129 (60%) |
| II | 32/131 (24%) | 40/129 (31%) |
| III | 17/131 (13%) | 12/129 (9%) |
| Heavy chain isotype | ||
| IgG | 79 (57%) | 71 (52%) |
| IgA | 33 (24%) | 33 (24%) |
| IgD | 1 (1%) | 0 |
| Light chain myeloma | 26 (19%) | 33 (24%) |
| Light chain isotype | ||
| κ | 87 (63%) | 102 (75%) |
| λ | 52 (37%) | 35 (26%) |
| Cytogenetic aberrations∗ | ||
| t(4;14) | 19/94 (20%) | 10/99 (10%) |
| t(11;14) | 17/88 (19%) | 20/96 (21%) |
| t(14;16) | 2/90 (2%) | 0/97 |
| del13q14 | 59/97 (61%) | 45/104 (43%) |
| del17p13 | 14/98 (14%) | 15/107 (14%) |
| Gain1q (>3 copies) | 11/97 (11%) | 12/105 (11%) |
| High risk† | 39/91 (43%) | 31/98 (32%) |
| Standard risk | 52/91 (57%) | 67/98 (68%) |
| LDH | ||
| Normal | 115 (83%) | 114 (83%) |
| Elevated | 24 (17%) | 24 (17%) |
| eGFR | ||
| ≥60 mL/min per 1.73 m2 | 108 (82%) | 106 (79%) |
| <60 mL/min per 1.73 m2 | 23 (18%) | 28 (21%) |
| Prior lines of therapy | ||
| 1 | 131 (94%) | 129 (94%) |
| 2 | 5 (4%) | 8 (6%) |
| 3 | 3 (2%) | 1 (1%) |
| Frontline HDCT/ASCT | 129 (93%) | 130 (94%) |
| Single | 83 (64%) | 71 (55%) |
| Tandem | 46 (36%) | 59 (45%) |
| TTP1, mo‡ | 34.3 (12.3-136.8) | 31.3 (12.1-131) |
| 12-24 | 44 (34%) | 47 (36%) |
| 24-48 | 42 (33%) | 51 (39%) |
| >48 | 43 (33%) | 32 (25%) |
| Prior therapies | ||
| Bortezomib | 107 (77%) | 106 (77%) |
| Thalidomide | 31 (22%) | 25 (18%) |
| Lenalidomide | 12 (9%) | 18 (13%) |
| Interferon | 9 (6%) | 9 (7%) |
| Chemotherapy only | 14 (10%) | 10 (7%) |
| Prior maintenance therapies | ||
| Any | 46 (33%) | 50 (36%) |
| Thalidomide | 25 (18%) | 19 (14%) |
| Interferon | 9 (6%) | 9 (7%) |
| Lenalidomide | 6 (4%) | 10 (7%) |
| Bortezomib | 5 (4%) | 12 (9%) |
| Ixazomib | 4 (3%) | 2 (1%) |
| Dexamethasone | 1 (1%) | 2 (1%) |
Data are presented as n (%), median (range), or n/N (%).
eGFR, estimated glomerular filtration rate; IgG/A/D, immunoglobulin G/A/D/; ISS, International Staging System; LDH, lactate dehydrogenase; WHO PS, World Health Organization performance status.
Data are not available for all randomized patients.
t(4;14), t(14;16), deletion 17p13, and gain 1q21 (>3 copies).
TTP1 in the n = 259 patients with frontline HDCT/ASCT.