Efficacy
Twenty‐eight, PD
DISEASE, MINOR, MYELOMA, RELAPSED/REFRACTORY MULTIPLE MYELOMA
Twenty‐eight patients treated at all dose levels (18 at the RD cohort) were evaluable for efficacy as per IMWG criteria. Eight patients were not evaluable because they did not receive at least one complete cycle. Overall, 10 patients showed PR or better, including two sCRs, one CR, three VGPRs, and four PRs (ORR = 35.7%; 95%CI, 18.6–55.9%). The clinical benefit rate was 82.1% (95%CI, 63.1%–93.9%) (Table Antitumor activity according to IMWG criteria in relapsed/refractory multiple myeloma patients
Abbreviations: BTZ, bortezomib; CR, complete response; DXM, dexamethasone; IMWG, International Myeloma Working Group; MR, minor response; ORR, overall response rate; PD, progressive disease; PR, partial response; RD, recommended dose; sCR, stringent complete response; SD, stable disease; VGPR, very good partial response.ORR includes sCR, CR, VGPR, and PR.Clinical benefit rate includes sCR, CR, VGPR, PR, MR, or SD.At the RD, one sCR, one VGPR, and two PRs occurred (ORR = 22.2%; 95%CI, 6.4%–47.6%). Both PRs were observed in refractory patients (one patient was refractory to lenalidomide and the other one to BTZ, lenalidomide, and pomalidomide). The clinical benefit rate was 77.8% (95%CI, 52.4–93.6%) (Table At all dose levels, the median DoR was 14.4 months (95%CI, 1.8 months‐23.9 months) and the median PFS was 4.1 months (95%CI, 2.1–10.4 months). At the RD cohort, the median DoR was 12.3 months (95%CI, 1.8–23.9 months) and the median PFS was 2.8 months (95%CI, 1.2–4.8 months).