CMG: Research and Clinical Trials
The preclinical research is focused on the development of anti-tumor vaccines, on the studies of chromosomal and genetic abnormalities that frequently occur in patients with multiple myeloma as well as on angiogenesis and on the evaluation of prognostic factors.
For more information on preclinical and laboratory research, see the web pages of the Laboratory of Experimental Hematology and Immunotherapy (LEHABI) at the Departments of Internal Medicine and Hematooncology (IHOK) and Department of Clinical Hematology (OKH), all at the Brno University Hospital.
Clinical Research and Randomized Studies
The clinical research is mainly directed on the allogeneic and autologous transplantation. It is also focused on the retransplantation for relapsed patients and on the phase I / II studies using anti-tumor vaccines.
The principal CMG activity over the previous few years was the large multicentric study named 4W that started in 1996. Twenty-eight centers from the Czech Republic and 1 center from Slovakia participated in this study. The protocol consisted of 4 cycles of induction therapy using VAD followed by autologous transplantation. Patients were then randomized into two groups receiving interferon-alpha or interferon-alpha plus dexamethasone as maintenance treatment. The inclusion of autologous transplantation in the multicentric study ensured up-to-date treatment for eligible Czech and Slovak patients with multiple myeloma. Thanks to this study we have become one of the 15 groups in the world that organize the multicentric clinical studies in multiple myeloma.
A new study named CMG 2002 was started in March 2002. It continues and further develops the treatment strategies used successfully in the preceding 4W clinical study. The induction therapy using VAD or VID is followed by autologous transplantation. Patients are randomized into two groups that receive interferon-alpha with or without and intensification chemotherapy using CED. This part Thus, the golden standard of autologous transplantation is supplemented with a research protocol comparing two types of post-transplantation treatment.
CMG has recently started to participate in the multicentric study comparing Thalidomide/Dexamethasone versus Melphalan/Prednisone for induction therapy and Thalidomide/Interferon-alpha versus Interferon-alpha for maintenance therapy (CEMGS 1 study). The study enrolls patients who are not eligible for the transplantation program.
The study has been active since July 2004 and includes centers from Austria, Slovakia, Czech Republic, Slovenia, Croatia, and Germany. The principal investigator is Professor Ludwig from the Vienna University Hospital. The first patient from Czech Republic was enrolled in July 2004.
The latest study which CMG participate in is An International single-arm protocol to provide expanded access to VELCADE (tm) for patients with multiple myeloma who have received at least two previous lines of therapy and are refractory to or have relapsed after their last therapy for multiple myeloma (EAP). Patients enrolled in the study are treated with VELCADE for up to eight 3-week treatment cycles. (if approved by the sponsor, treatment may be extended for patients who respond.) The study has been active since March 2004 and includes centers from USA, Canada, Australia and EU countries. The first patient from Czech Republic was enrolled in December 2004.