Low-dose decitabine plus bortezomib-dexamethasone therapy is well-tolerated and highly effective on first-relapsed multiple myeloma: a single-center phase 2 trial.

An open-label, single-center, phase 2 trial of a second-line therapy comprising low-dose decitabine (DAC) plus bortezomib (Bort) and dexamethasone (DXM) (Dvd) in relapsed and/or refractory multiple myeloma (RRMM) patients was conducted to screen available and inexpensive agents, aiming to work synergistically with other existing anti-melanoma drugs at reasonable prices, and effectively treat Bort and/or Len-refractory patients. Forty-seven patients were included according to the inclusion criteria, with only 1 withdrawal due to premature death. After 17.2 (range: 0.5-24.1) months of median follow-up, all the 46 cases had halted or completed DVd therapy per protocol, with an overall response rate (ORR) of 87.0%. Meanwhile, DVd was indicated to induce high, deep, and lasting responses, dependent of prior treatment or baseline characteristics. The results revealed that DVd is well-tolerated and highly effective in the treatment of first-relapsed RRMM (including those with Bort-refractory disease) patients.