Patient characteristics for CC-5013 phase 3 trial for advanced and refractory myeloma
. | % of patients . | . | |
|---|---|---|---|
| Parameter . | 25 mg, n = 27 . | 50 mg, n = 28 . | |
| Age 60 y or older | 78 | 54 | |
| B2M 4 mg/L or greater | 46 | 39 | |
| LDH 190 IU/L or greater | 31 | 41 | |
| Abnormal cytogenetics | 58 | 47 | |
| Deletion 13 | 35 | 27 | |
| Prior therapy 60 mo or more | 58 | 41 | |
| Prior high-dose therapy | 85 | 86 | |
| More than 1 cycle | 46 | 48 | |
| Prior THAL | 92 | 93 | |
. | % of patients . | . | |
|---|---|---|---|
| Parameter . | 25 mg, n = 27 . | 50 mg, n = 28 . | |
| Age 60 y or older | 78 | 54 | |
| B2M 4 mg/L or greater | 46 | 39 | |
| LDH 190 IU/L or greater | 31 | 41 | |
| Abnormal cytogenetics | 58 | 47 | |
| Deletion 13 | 35 | 27 | |
| Prior therapy 60 mo or more | 58 | 41 | |
| Prior high-dose therapy | 85 | 86 | |
| More than 1 cycle | 46 | 48 | |
| Prior THAL | 92 | 93 | |
Patient characteristics were comparable between the 2 treatment arms, including almost universal exposure to prior thalidomide (THAL); more patients 60 years or older were randomly assigned to CC-5013 25 mg (P = .08).