Summary of responses
| Response . | Part 1 . | Part 2 . | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Daratumumab 2 mg/kg + lenalidomide/ dexamethasone (n = 3) . | Daratumumab 4 mg/kg + lenalidomide/ dexamethasone (n = 3) . | Daratumumab 8 mg/kg + lenalidomide/ dexamethasone (n = 4) . | Daratumumab 16 mg/kg + lenalidomide/ dexamethasone (n = 3) . | Daratumumab 16 mg/kg + lenalidomide/dexamethasone (n = 32) . | |||||||
| No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | 95% CI . | |
| sCR | 1 | 33.3 | 2 | 66.7 | 2 | 50 | 0 | 8 | 25 | 11.5-43.4 | |
| CR | 0 | 0 | 0 | 0 | 3 | 9.4 | 2.0-25.0 | ||||
| VGPR | 1 | 33.3 | 1 | 33.3 | 0 | 2 | 66.7 | 9 | 28.1 | 13.7-46.7 | |
| VGPR or better* | 2 | 66.7 | 3 | 100 | 2 | 50 | 2 | 66.7 | 20 | 62.5 | 43.7-78.9 |
| PR | 1 | 33.3 | 0 | 1 | 25.0 | 0 | 6 | 18.8 | 7.2-36.4 | ||
| ORR† | 3 | 100 | 3 | 100 | 3 | 75 | 2 | 66.7 | 26 | 81.3 | 63.6-92.8 |
| MR | 0 | 0 | 1 | 25 | 0 | 2 | 6.3 | 0.8-20.8 | |||
| Stable disease | 0 | 0 | 0 | 1 | 33.3 | 3 | 9.4 | 2.0-25.0 | |||
| Progressive disease | 0 | 0 | 0 | 0 | 0 | — | |||||
| Not evaluable | 0 | 0 | 0 | 0 | 1 | 3.1 | 0.1-16.2 | ||||
| Response . | Part 1 . | Part 2 . | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Daratumumab 2 mg/kg + lenalidomide/ dexamethasone (n = 3) . | Daratumumab 4 mg/kg + lenalidomide/ dexamethasone (n = 3) . | Daratumumab 8 mg/kg + lenalidomide/ dexamethasone (n = 4) . | Daratumumab 16 mg/kg + lenalidomide/ dexamethasone (n = 3) . | Daratumumab 16 mg/kg + lenalidomide/dexamethasone (n = 32) . | |||||||
| No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | 95% CI . | |
| sCR | 1 | 33.3 | 2 | 66.7 | 2 | 50 | 0 | 8 | 25 | 11.5-43.4 | |
| CR | 0 | 0 | 0 | 0 | 3 | 9.4 | 2.0-25.0 | ||||
| VGPR | 1 | 33.3 | 1 | 33.3 | 0 | 2 | 66.7 | 9 | 28.1 | 13.7-46.7 | |
| VGPR or better* | 2 | 66.7 | 3 | 100 | 2 | 50 | 2 | 66.7 | 20 | 62.5 | 43.7-78.9 |
| PR | 1 | 33.3 | 0 | 1 | 25.0 | 0 | 6 | 18.8 | 7.2-36.4 | ||
| ORR† | 3 | 100 | 3 | 100 | 3 | 75 | 2 | 66.7 | 26 | 81.3 | 63.6-92.8 |
| MR | 0 | 0 | 1 | 25 | 0 | 2 | 6.3 | 0.8-20.8 | |||
| Stable disease | 0 | 0 | 0 | 1 | 33.3 | 3 | 9.4 | 2.0-25.0 | |||
| Progressive disease | 0 | 0 | 0 | 0 | 0 | — | |||||
| Not evaluable | 0 | 0 | 0 | 0 | 1 | 3.1 | 0.1-16.2 | ||||
Response was assessed by a computerized algorithm based on International Uniform Response Criteria Consensus Recommendations. Among the 11 patients with sCR/CRs, 3 were initially classified as having VGPR per International Myeloma Working Group criteria and then confirmed as having sCR/CR by daratumumab interference reflex assay.
MR, minimal response.
sCR + CR + VGPR.
sCR + CR + VGPR + PR.