RxTrials Institute Drug Pipeline Alert

Takeda Pharmaceutical’s Velcade, combined with GlaxoSmithKline’s Alkeran and prednisone, proved superior to the latter two drugs alone in patients with newly diagnosed myeloma who were not eligible for high-dose therapy, according to a Phase III study.

The standard treatment for patients with multiple myeloma who are not candidates for high-dose therapy is Alkeran (melphalan) and prednisone. In the trial, 682 patients were randomly assigned to receive nine six-week cycles of Alkeran and prednisone, either alone or with Velcade (bortezomib), according to results published in The New England Journal of Medicine.

The primary endpoint was the time to disease progression, which was 24 months for patients receiving the Velcade combination compared with 16.6 months in participants who received only Alkeran and prednisone. Researchers said 71 percent of patients had a partial response or better in the Velcade group compared with 35 percent in the control group; complete-response rates were 30 percent and 4 percent, respectively.