Response of patients treated at the MTD (dose level 4 of phase 1 and phase 2)
| . | All patients (all len-refractory), n = 66, % . | Len- and bor-refractory patients, n = 42, % . | Patients with high-risk cytogenetic abnormalities,* n = 24, % . | Patients treated with REP, directly following development of len-refractory disease (25 mg len or equivalent in case of renal insufficiency), n = 46, % . |
|---|---|---|---|---|
| sCR | 1.5 | 0 | 0 | 0 |
| CR | 3.0 | 2.4 | 0 | 0 |
| VGPR | 18.2 | 21.4 | 20.8 | 15.2 |
| PR | 44.0 | 36.1 | 45.9 | 50.0 |
| MR | 16.6 | 21.1 | 16.6 | 17.4 |
| SD | 7.6 | 9.5 | 4.2 | 10.9 |
| PD | 9.1 | 9.5 | 12.5 | 6.5 |
| ≥VGPR | 22.7 | 23.8 | 20.8 | 15.2 |
| ≥PR | 66.7 | 59.9 | 66.7 | 65.2 |
| ≥MR | 83.3 | 81.0 | 83.3 | 82.6 |
| . | All patients (all len-refractory), n = 66, % . | Len- and bor-refractory patients, n = 42, % . | Patients with high-risk cytogenetic abnormalities,* n = 24, % . | Patients treated with REP, directly following development of len-refractory disease (25 mg len or equivalent in case of renal insufficiency), n = 46, % . |
|---|---|---|---|---|
| sCR | 1.5 | 0 | 0 | 0 |
| CR | 3.0 | 2.4 | 0 | 0 |
| VGPR | 18.2 | 21.4 | 20.8 | 15.2 |
| PR | 44.0 | 36.1 | 45.9 | 50.0 |
| MR | 16.6 | 21.1 | 16.6 | 17.4 |
| SD | 7.6 | 9.5 | 4.2 | 10.9 |
| PD | 9.1 | 9.5 | 12.5 | 6.5 |
| ≥VGPR | 22.7 | 23.8 | 20.8 | 15.2 |
| ≥PR | 66.7 | 59.9 | 66.7 | 65.2 |
| ≥MR | 83.3 | 81.0 | 83.3 | 82.6 |
Len, lenalidomide; bor, bortezomib; SD, stable disease; PD, progressive disease.
High-risk disease was defined by the presence of t(4;14), t(14;16), del(17p), and/or ampl(1q) as determined by FISH on purified MM cells before start of REP treatment.