OCT is happy to announce that the first patient was enrolled into the multiple myeloma study conducted in Russia. The study is performed at 5 sites in Russia. OCT aims to enroll 20 patients into the clinical trial.
The trial will involve approximately 400 patients in total. As its primary objective, the study will assess whether the study drug extends progression-free survival, and it will also evaluate overall response rate, survival, and safety.
In previous clinical trials, the study drug has demonstrated significant anti-cancer activity. This clinical study will be conducted in multiple myeloma patients who have relapsed on prior bortezomib therapy, but who are not refractory to bortezomib.
Multiple myeloma is a cancer of plasma cells. Plasma cell is a type of white blood cell normally responsible for producing antibodies. Myeloma is diagnosed with blood tests, bone marrow examination, urine protein electrophoresis, and X-rays of commonly involved bones.
Remissions may be induced with steroids, chemotherapy, proteasome inhibitors (e.g. bortezomib), immunomodulatory drugs sand stem cell transplantation. Radiation therapy is sometimes used to reduce pain from bone lesions.
Myeloma develops in 1–4 per 100,000 people per year. It is more common in men. With conventional treatment, median survival is 3–4 years, which may be extended to 5–7 years or longer with advanced treatments. Multiple myeloma represents approximately 1% of all cancers in white individuals and 2% of all cancers in black individuals.
For oncology studies, where competition for patients and complexity of design are leading issues, we use our experience and relationships with sites to manage and support our clients’ efforts to meet enrollment goals in Russia, CIS and CEE regions. It is not our first clinical trial in hematology malignancies. Our CRO have successfully conducted a trial in T-cell Leukemia and AML in Russia.