Retreatment with Velcade (bortezomib) alone or in combination is an effective treatment for patients with relapsed multiple myeloma, according to a recent article published in the American Journal of Hematology.

Velcade, which was first approved in 2003, has previously been evaluated as a single-agent treatment in Phase 2 and 3 trials in patients with relapsed and/or refractory myeloma. It is currently the only single agent with a demonstrated survival benefit in patients with relapsed myeloma.

The prospective clinical trial published in the journal enrolled 32 patients with relapsed myeloma who had previously tolerated Velcade as a single agent or in combination with other therapeutic agents. In order to participate, the patients had to achieve, at minimum, a partial response to Velcade for at least four months, and they could not have received any intervening treatment with other drugs.

Participants were retreated with Velcade on days 1, 4, 8, and 11 of a 21-day cycle. Velcade was administered as both a single-agent and in combination with dexamethasone (Decadron), thalidomide (Thalomid), and doxorubicin (Adriamycin). The starting dose was equal to the dose at which the patient had ended the initial treatment.

The median time for progression-free survival was 6.6 months. The overall response rate was 50 percent, with 13 percent of patients achieving complete response and 38 percent of patients achieving partial response.

During treatment, 41 percent of patients experienced new or worsening peripheral neuropathy, which is pain and numbness in hands and feet. Four patients experienced treatment-related serious adverse events, which included anemia, congestive heart failure, low white blood cell count, and low blood platelet count. Four patients died during the trial period, two from disease progression, one from sepsis, and one from irregular heartbeat. However, all of the deaths were considered to be unrelated to Velcade.

Based on these results, the authors of the study conclude that Velcade retreatment appears to be a feasible, effective, and well-tolerated treatment for patients with relapsed myeloma. The authors point out that myeloma patients commonly receive several different treatment regimens during the course of the disease, and Velcade retreatment offers yet another option for treatment of myeloma.

For more information, please read the study in the American Journal of Hematology (abstract).