The study is being conducted at Karolinska University Hospital Huddinge and at Uddevalla Hospital. The treatment lasts for a total of 14 weeks with 2 doses per month. Three dose levels of ODX are studied, 3mg\/kg body weight, 6mg\/kg, and 9mg\/kg. The Principal Investigator (PI) is Dr Katarina Uttervall, MD, PhD, Department of Hematology\/HERM, Karolinska University Hospital Huddinge. Dr Dorota Knut is the principal investigator at the Department of Hematology at Uddevalla Hospital. Analysis of biomarkers takes place at the Central Laboratory, Karolinska University Hospital Solna, NKS. Adult myeloma patients with progressive treatment-resistant disease, who have previously received 1\u20135 prior lines of therapy, are included in the study. The primary objective is to confirm ODX safety and tolerability and with a secondary objective to demonstrate indications of treatment response.<\/p>\n
Dose group 2 (6mg\/kg) has been fully recruited. Two patients in dose group 2 have progressive disease after completion of treatment. The other 2 patients will finish the treatment in early December. The DMC (Independent Data Monitoring Committee) approves the continuation to dose group 3. No ODX related serious side effects have been noted. A new patient for dose group 3 has been screened.
\nFollow-up of all patients who have achieved stable disease is done to determine how long the disease-slowing effect persists after the ODX treatment has been discontinued, i.e., until new progress.<\/p>\n