Baseline characteristics
| Variable . | Phase 1 (N = 24) . | Phase 2 (N = 55) . | All patients (N = 69) . |
|---|---|---|---|
| Age | |||
| Median-years (range) | 71 (50-82) | 69 (41-84) | 69 (41-84) |
| Sex | |||
| Female | 9 (37.5%) | 27 (49%) | 33 (48%) |
| Male | 15 (62.5%) | 28 (51%) | 36 (52%) |
| International Staging System stage | |||
| I | 13 (54%) | 28 (51%) | 34 (49%) |
| II | 10 (42%) | 21 (38%) | 27 (39%) |
| III | 1 (4%) | 6 (11%) | 8 (12%) |
| Myeloma protein class | |||
| IgG | 16 (67%) | 34 (62%) | 42 (61%) |
| IgA | 4 (17%) | 13 (24%) | 16 (23%) |
| Bence-Jones protein | 3 (12%) | 8 (14%) | 10 (15%) |
| Nonsecretory | 1 (4%) | 0 | 1 (1%) |
| Karnofsky performance status, % | |||
| 60-70 | 3 (12%) | 7 (13%) | 10 (14%) |
| 80 | 5 (21%) | 9 (16%) | 13 (19%) |
| 90-100 | 16 (67%) | 39 (71%) | 46 (67%) |
| Serum β2-microglobulin level | |||
| Median (mg/L) | 2.9 (0.03-9) | 3 (0.03-9) | 3 (1.6-12) |
| Months from diagnosis to on study | |||
| Median (range) | 59 (13-203) | 53 (11-203) | 53 (11-203) |
| Prior lines of therapy | |||
| Median (range) | 3 (1-3) | 3 (1-3) | 3 (1-3) |
| Prior therapies | |||
| Lenalidomide | 24 (100%) | 55 (100%) | 69 (100%) |
| Bortezomib | 20 (83%) | 46 (84%) | 58 (84%) |
| Thalidomide | 4 (17%) | 11 (20%) | 14 (20%) |
| Autologous transplant | 7 (29%) | 18 (33%) | 23 (33%) |
| Allogeneic transplant | 3 (12%) | 9 (16%) | 10 (15%) |
| Previous lenalidomide | |||
| Relapsed | 9 (37.5%) | 18 (33%) | 23 (33%) |
| Refractory | 15 (62.5%) | 37 (67%) | 46 (67%) |
| Previous bortezomib | |||
| Relapsed | 4 (17%) | 14 (25%) | 17 (25%) |
| Refractory | 10 (42%) | 20 (36%) | 27 (39%) |
| Not available | 6 (25%) | 12 (22%) | 14 (20%) |
| FISH* | |||
| High risk | 4 (17%) | 13 (24%) | 18 (26%) |
| Standard risk | 9 (37%) | 31 (56%) | 35 (51%) |
| Not available | 11 (46%) | 11 (20%) | 16 (23%) |
| Chromosome abnormalities | |||
| Del 13 | 6 (25%) | 18 (33%) | 24 (35%) |
| t(4;14) | 2 (8%) | 6 (11%) | 8 (12%) |
| t(11;14) | 2 (8%) | 10 (18%) | 12 (17%) |
| t(14;16) | 0 | 2 (4%) | 3 (4%) |
| Del17 | 2 (8%) | 5 (9%) | 8 (12%) |
| Variable . | Phase 1 (N = 24) . | Phase 2 (N = 55) . | All patients (N = 69) . |
|---|---|---|---|
| Age | |||
| Median-years (range) | 71 (50-82) | 69 (41-84) | 69 (41-84) |
| Sex | |||
| Female | 9 (37.5%) | 27 (49%) | 33 (48%) |
| Male | 15 (62.5%) | 28 (51%) | 36 (52%) |
| International Staging System stage | |||
| I | 13 (54%) | 28 (51%) | 34 (49%) |
| II | 10 (42%) | 21 (38%) | 27 (39%) |
| III | 1 (4%) | 6 (11%) | 8 (12%) |
| Myeloma protein class | |||
| IgG | 16 (67%) | 34 (62%) | 42 (61%) |
| IgA | 4 (17%) | 13 (24%) | 16 (23%) |
| Bence-Jones protein | 3 (12%) | 8 (14%) | 10 (15%) |
| Nonsecretory | 1 (4%) | 0 | 1 (1%) |
| Karnofsky performance status, % | |||
| 60-70 | 3 (12%) | 7 (13%) | 10 (14%) |
| 80 | 5 (21%) | 9 (16%) | 13 (19%) |
| 90-100 | 16 (67%) | 39 (71%) | 46 (67%) |
| Serum β2-microglobulin level | |||
| Median (mg/L) | 2.9 (0.03-9) | 3 (0.03-9) | 3 (1.6-12) |
| Months from diagnosis to on study | |||
| Median (range) | 59 (13-203) | 53 (11-203) | 53 (11-203) |
| Prior lines of therapy | |||
| Median (range) | 3 (1-3) | 3 (1-3) | 3 (1-3) |
| Prior therapies | |||
| Lenalidomide | 24 (100%) | 55 (100%) | 69 (100%) |
| Bortezomib | 20 (83%) | 46 (84%) | 58 (84%) |
| Thalidomide | 4 (17%) | 11 (20%) | 14 (20%) |
| Autologous transplant | 7 (29%) | 18 (33%) | 23 (33%) |
| Allogeneic transplant | 3 (12%) | 9 (16%) | 10 (15%) |
| Previous lenalidomide | |||
| Relapsed | 9 (37.5%) | 18 (33%) | 23 (33%) |
| Refractory | 15 (62.5%) | 37 (67%) | 46 (67%) |
| Previous bortezomib | |||
| Relapsed | 4 (17%) | 14 (25%) | 17 (25%) |
| Refractory | 10 (42%) | 20 (36%) | 27 (39%) |
| Not available | 6 (25%) | 12 (22%) | 14 (20%) |
| FISH* | |||
| High risk | 4 (17%) | 13 (24%) | 18 (26%) |
| Standard risk | 9 (37%) | 31 (56%) | 35 (51%) |
| Not available | 11 (46%) | 11 (20%) | 16 (23%) |
| Chromosome abnormalities | |||
| Del 13 | 6 (25%) | 18 (33%) | 24 (35%) |
| t(4;14) | 2 (8%) | 6 (11%) | 8 (12%) |
| t(11;14) | 2 (8%) | 10 (18%) | 12 (17%) |
| t(14;16) | 0 | 2 (4%) | 3 (4%) |
| Del17 | 2 (8%) | 5 (9%) | 8 (12%) |
High-risk FISH was defined as the presence of at least one of the following abnormalities: t(4;14), t(14;16), or del17.