Klin Onkol 2009; 22(2): 67-72.
Summary
Backgrounds: On June 2006, phase II clinical trial focused on anticancer vaccination of multiple myeloma patients, was started. On September 2007,the immune and clinical response evaluation of first four patients was finished. The anticancer vaccine contained dendritic cells loaded with monoclonal immunoglobulin produced by myeloma cells.
Methods and Patients: Within the frame of phase II clinical trial were vaccinated four myeloma patients with stable disease. It was administered six vaccines for each patient, monthly. The dendritic cells were cultured from the patient’s peripheral blood mononucle ar cells and loaded with autologous monoclonal immunoglobulin under the good manufacturing practice conditions.
After the safety and quality control, the satisfactory vaccine was administered to the patient. The functional characteristic of dendritic cells was evaluated using flow cytometry, the immune response was evaluated using ELISpot. The clinical response was monitored using monoclonal immunoglobulin concentration in patient’s sera.
Results and Conclusion: The immune response detected using ELISpot was observed in 3/ 4 patients.
The monoclonal immunoglobulin concentration was change able for all twelve months, but never exceeded the range of 25% for minimal clinical response achievement. During the vaccination, no significant toxicities or negative side-effects were observed. The clinical trial is going on with vaccination other patients with multiple myeloma.
