Characteristics of study patients (N = 704)
| Characteristic . | No prior exposure to thalidomide, n = 430 . | Prior exposure to thalidomide, n = 274 . | ||
|---|---|---|---|---|
| Len/Dex, n = 226 . | Placebo/Dex, n = 204 . | Len/Dex, n = 127 . | Placebo/Dex, n = 147 . | |
| Median age, y | 64 | 64 | 63 | 62 |
| Median prior lines of therapy, no. | 2‡ | 2§ | 3‡ | 3§ |
| Median time since diagnosis, y | 2.8‡ | 2.9§ | 4‡ | 4.3§ |
| Median baseline ECOG score | 1 | 1 | 0 | 1 |
| Mean β2-microglobulin, mg/L (SD) | 4.1 (2.7) | 4.2 (3.1) | 4.8 (4.6) | 4.0 (2.6) |
| Mean hemoglobin, g/L (SD) | 1.16 (0.17) | 1.18 (0.18) | 1.18 (0.21) | 1.17 (0.19) |
| Mean serum M-protein, g/dL (SD) | 2.6 (1.6) | 2.6 (1.7) | 2.6 (1.9) | 2.7 (1.6) |
| Mean ANC-PS, ×109/L (SD) | 3.4 (1.8)‡ | 3.5 (1.7) | 2.9 (1.3)‡ | 3.2 (1.6) |
| Mean creatinine, μM (SD) | 1.0 (0.4) | 1.0 (0.4) | 1.1 (0.4) | 1.0 (0.4) |
| Previous transplantation(s), % | ||||
| 0 | 42 | 46 | 39 | 39 |
| 1 | 46 | 41 | 52 | 49 |
| 2 | 11 | 13 | 9 | 12 |
| Prior dexamethasone, % | 65 | 59 | 89 | 84 |
| Prior bortezomib, % | 7 | 6 | 9 | 10 |
| Prior vincristine, % | 61 | 58 | 51 | 52 |
| MM disease status, % | ||||
| 1 | 5 | 4 | 4 | 4 |
| 2 | 29 | 31 | 33 | 33 |
| 3 | 66 | 65 | 63 | 63 |
| Median duration of prior thalidomide treatment, mo* | N/A | N/A | 10 | 10 |
| Median time since last thalidomide exposure, mo† | N/A | N/A | 7 | 5 |
| Characteristic . | No prior exposure to thalidomide, n = 430 . | Prior exposure to thalidomide, n = 274 . | ||
|---|---|---|---|---|
| Len/Dex, n = 226 . | Placebo/Dex, n = 204 . | Len/Dex, n = 127 . | Placebo/Dex, n = 147 . | |
| Median age, y | 64 | 64 | 63 | 62 |
| Median prior lines of therapy, no. | 2‡ | 2§ | 3‡ | 3§ |
| Median time since diagnosis, y | 2.8‡ | 2.9§ | 4‡ | 4.3§ |
| Median baseline ECOG score | 1 | 1 | 0 | 1 |
| Mean β2-microglobulin, mg/L (SD) | 4.1 (2.7) | 4.2 (3.1) | 4.8 (4.6) | 4.0 (2.6) |
| Mean hemoglobin, g/L (SD) | 1.16 (0.17) | 1.18 (0.18) | 1.18 (0.21) | 1.17 (0.19) |
| Mean serum M-protein, g/dL (SD) | 2.6 (1.6) | 2.6 (1.7) | 2.6 (1.9) | 2.7 (1.6) |
| Mean ANC-PS, ×109/L (SD) | 3.4 (1.8)‡ | 3.5 (1.7) | 2.9 (1.3)‡ | 3.2 (1.6) |
| Mean creatinine, μM (SD) | 1.0 (0.4) | 1.0 (0.4) | 1.1 (0.4) | 1.0 (0.4) |
| Previous transplantation(s), % | ||||
| 0 | 42 | 46 | 39 | 39 |
| 1 | 46 | 41 | 52 | 49 |
| 2 | 11 | 13 | 9 | 12 |
| Prior dexamethasone, % | 65 | 59 | 89 | 84 |
| Prior bortezomib, % | 7 | 6 | 9 | 10 |
| Prior vincristine, % | 61 | 58 | 51 | 52 |
| MM disease status, % | ||||
| 1 | 5 | 4 | 4 | 4 |
| 2 | 29 | 31 | 33 | 33 |
| 3 | 66 | 65 | 63 | 63 |
| Median duration of prior thalidomide treatment, mo* | N/A | N/A | 10 | 10 |
| Median time since last thalidomide exposure, mo† | N/A | N/A | 7 | 5 |
ANC-PS indicates absolute neutrophil count–phosphotidyl serine; Dex, dexamethasone; ECOG, Eastern Cooperative Oncology Group; Len, lenalidomide; MM, multiple myeloma; N/A, not applicable; NS, not significant; SD, standard deviation.
Data missing for 3 patients receiving lenalidomide plus dexamethasone and 2 patients receiving dexamethasone alone.
Data missing for 2 patients receiving lenalidomide plus dexamethasone and 2 patients receiving dexamethasone alone.
P value less than .05 for patients receiving lenalidomide plus dexamethasone is for comparison between no prior exposure vs prior exposure to thalidomide, based on Fisher exact test, without adjustment for multiplicity.
P value less than .05 for patients receiving dexamethasone alone is for comparison between no prior exposure vs prior exposure to thalidomide, based on Fisher exact test, without adjustment for multiplicity.