Expert: Poland's first non-commercial study of cancer drugs
We have started the first in our country non-commercial clinical trial of triple therapy used in the treatment of multiple myeloma - told PAP president of the Polish Myeloma Consortium, Dr. Dominik Dytfeld from Poznan University of Medical Sciences
The expert spoke about the study during the 16th International Myeloma Workshop in New Delhi. In his opinion, this is definitely the first such study in Polish haematology, and perhaps in Polish oncology. Many cancer drugs have already been tested on patients in Poland, but the studies were carried out on behalf of pharmaceutical companies, and Polish doctors were only their subcontractors. Now they carry out the study of their own design.
"Our study is an original project conducted jointly with the University of Chicago, where Prof. Andrzej Jakubowiak works, one of the world\'s foremost specialists in the in the treatment of multiple myeloma, "- told PAP Dr. Dominik Dytfeld from the Department of Haematology and Bone Marrow Transplantation, Poznan University of Medical Sciences.
The study will include a total of 200 patients, 140 in Poland and 60 in the United States. Three drugs will be tested: carfilzomib (proteasome inhibitor), lenalidomide (immunomodulatory drug) and dexamethasone (synthetic glucocorticoid). They will be given as a combination to patients with multiple myeloma (blood cancer), who underwent the first autologous bone marrow transplantation (from haematopoietic cells taken from the patient).
"We want to see if such a triple supportive therapy after transplantation yields better results than the administration of lenalidomide only" - explained Dr Dytfeld. Therefore, the patients participating in the study will be divided into two groups: one group will get all three drugs, and the other group just one drug. Then the results of treating all of these patients will be compared.
President of the Polish Myeloma Consortium emphasised that such a non-commercial study can not be used for new drug registration, or to change its indications by pharmaceutical companies, or for marketing purposes. It\'s only purpose is to develop new treatment standards. This is a novelty in Polish oncology. The study has already attracted interest of haematologists from Norway, Sweden and Denmark.
Four Polish haematology centres (in Poznań, Gorzów Wielkopolski, Wrocław and Warsaw) are already involved in the study. Institution in Lublin and Łódź are expected to join them soon. Tested drugs are supplied by their manufacturers, Celgene and Amgen. Six Polish patients have already been included in the study, the remaining patients from our country will be included over the next few months.
The Polish Myeloma Consortium plans to start another non-commercial study with another new generation drug called daratumamab. It is used in the treatment of multiple myeloma with monoclonal antibody. "We want to test its effects in the treatment of so-called residual disease in multiple myeloma" - said Dr. Dytfeld.
The expert explained that at the residual disease stage the patient feels good and has no symptoms of myeloma, for example renal insufficiency, and the disease is in remission. However, various methods can detect cancer cells (plasma cells) or abnormal monoclonal proteins in his body. To that end, the patient\'s blood or urine is tested (to detect the abnormal proteins); bone marrow sample analysis is an even more accurate method.
"We want to check whether or not to start treatment as early as the time of onset of residual disease, the disease that is detectable only at the molecular level" - said Dr. Dytfeld. Even 5-10 years ago no one knew about residual disease in multiple myeloma. Soon, with the introduction of better diagnostic methods, it may become a determinant of treatment strategy.
The expert told PAP that residual disease in multiple myeloma treatment will be the main topic of the conference, which will be held on April 20 in Wrocław.
"We have made huge advances in the treatment of multiple myeloma. There are six different types of therapeutic molecules, although not all of them are reimbursed in Poland. However, clinical trials and non-commercial studies such as ours increase access to them also in our country" - added Dr. Dytfeld. Another Polish non-commercial study using monoclonal antibody may begin in 2018.
From New Delhi Zbigniew Wojtasiński
PAP - Science and Scholarship in Poland