Table II.
Response assessment of siltuximab with and without dexamethasone
| Treatment Plan A Siltuximab |
Treatment Plan B (Siltuximab + Dexamethasone) | Combination Siltuximab + Dexamethasonea | ||
|---|---|---|---|---|
| Before Dex | After Dex | |||
| Evaluable for response, N | 13 | 9 | 38 | 47 |
| Overall response rate (≥PR), N (%) | ||||
| PR by EBMT | 0 (0) | 5 (56) | 3 (8) | 8 (17) |
| PR by IMWG | 0 (0) | 5 (56) | 4 (11) | 9 (19) |
| Clinical Benefit Rate (≥MR), N (%) | ||||
| PR + MR by EBMT | 0 (0) | 5 (56) | 6 (16) | 11 (23) |
| PR +MR by IMWG | 0 (0) | 5 (56) | 8 (21) | 13 (28) |
| Stable disease by EBMT, N (%) | 8 (62) | 1 (11) | 26 (68) | 27 (57) |
| Disease progression, N (%) | 5 (39) | 2 (22) | 6 (16) | 8 (17) |
| Time to response (months), median (range) | N/A | 1.7 (0.7 – 8.1) | 1.5 (0.7 – 1.6) | 1.6 (0.7 – 8.1) |
| Duration of response (months), median (95% CI) | N/A | 12.0 (3.0 – 16.6) | 5.9 (4.9 – 9.9) | 5.9 (4.8 – 12.0) |
CI: Confidence interval. Dex: Dexamethasone. EBMT: European Group for Blood and Marrow Transplantation. IMWG: International Myeloma Working Group Criteria. MR: Minimal response. N/A: Not applicable. PR: Partial response.
a
Includes patients in Treatment Plan A who received siltuximab plus dexamethasone and all patients in Treatment Plan B.