Velcade® safety and effectiveness study: A case series of seven Filipino adult patients diagnosed with relapsed or refractory multiple myeloma.

Multiple myeloma is the second most prevalent blood cancer after non-Hodgkin's Lymphoma. It represents only 1% of all cancers but contributes to 2% of all cancer deaths. Multiple myeloma is still classified as a non-curable disease and its management involves chemotherapy, radiotherapy and- bone marrow transplantation with the aim of prolonging survival. Bortezomib (Velcade^®) is a new type of anti-myeloma drug and clinical trials show that patients under treatment have around 80% to 90% overall response rate. Hence bortezomib was placed on a monitored release status by the BFAD in June of 2005 and had required post-marketing surveillance study. It is therefore the objective of the study to describe the safety and effectiveness of bortezomib among Filipino patients with relapsed or refractory multiple myeloma. This is a case series study observing the effects of bortezomib use in seven adult Filipino diagnosed with multiple myeloma. Study participants were included if they were determined to have a relapsed multiple myeloma, who have received at least one prior therapy or have demonstrated disease progression during the last therapy. The 3 week treatment cycle for bortezomib (Velcade^®) begun at recommended dose of 1.3 mg/m² administered as an intravenous bolus injection twice weekly for two weeks (days 1,4, 8, and 11) followed by a 10-day rest period (days 12-21). It was administered as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter followed by a flush with 0.9% sodium chloride solution for injection. Eight cycles of bortezomib (Velcade^®) therapy were recommended for patients presenting response to treatment. Follow-up period lasted as long as the patient used bortezomib or if the patient has completed the 6 to 8 cycles of treatment. Overall, treatment responses to bortezomib (Velcade^®) range from a stable disease (2 patients) to minimal or partial response (4 patients) based on EBMT classifications. Two non-serious and seven serious adverse events, similar to previous clinical trials were reported. Based on the analysis of the seven eligible case reports on clinical experience with bortezomib (Velcade^®) in Filipinos with multiple myeloma, the effectiveness and safety profile is consistent with the previous studies conducted and the approved product label. The expected improvement in the activities of daily living was observed in this set of patients. No new safety signal is observed.