A Phase I/IIa Study of ODX (OsteoDex) in Multiple Myeloma
The current phase I/IIa trial is a multi-center, prospective, open-label, ascending dose study to evaluate safety and biological efficacy of up to 3 dose levels of ODX. Each dose cohort will consist of 4 subjects. Each subject will receive up to 7 doses of ODX, given at 2-week intervals, until unacceptable toxicity or disease progression. A follow-up visit will be conducted 2 weeks after the last dose. Primary objectives: • To determine the safety and tolerability of ODX in subjects with relapsed/refractory multiple myeloma. Secondary objectives: * To evaluate the preliminary efficacy of ODX, as determined by the IMWG response criteria, in subjects with relapsed/refractory multiple myeloma. * To evaluate the efficacy of ODX on serum biomarkers (M-protein, FLC, CTX, osteocalcin, and bone-specific S-ALP) in subjects with relapsed/refractory multiple myeloma. Exploratory objective • To evaluate time to progression by following M-protein and FLC levels as per clinical routine
• 1\. Subject (male or female) is ≥ 18 years of age at the time of signing the informed consent form (ICF).
• 2\. Documented diagnosis av multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria.
• 3\. Measurable disease defined as either:
⁃ Serum monoclonal paraprotein (M-protein) level ≥ 0.5 g/dL or urine M-protein level ≥ 200 mg/24 hours; or
⁃ Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain (FLC) ≥ 10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
‣ 4\. Subjects must have received 1-5 prior lines of therapy including a PI, IMiD and CD38 antibody\*.
‣ \*Patients eligible for inclusion should have received said treatments, i.e., according to clinical routine, unless contraindicated due to induced morbidity.
‣ 5\. Subjects must have documented evidence of progressive disease based on the IMWG criteria on or after their last line of therapy.
‣ 6\. Performance status ECOG 0-2 7. Laboratory requirements:
∙ Haematology:
∙ Neutrophils ≥ 1.0 x 109/l Hemoglobin ≥ 80 g/l Platelets ≥ 50 x 109/l
∙ Hepatic function:
∙ Total S/P-bilirubin ≤ 1.5 times the upper limit of normal (ULN) AST (SGOT) / ALT (SGPT) ≤ 2.5 times ULN
∙ Renal function:
∙ S/P-creatinine ≤ 1.5 times ULN
∙ Electrolytes:
∙ S/P-sodium, S/P-potassium, S/P-calcium corrected for S/P albumin , S/P-phosphate, and S/P magnesium, all within normal ranges. At the discretion of the Investigator, supplements may be given to correct these values, in which case electrolytes must be shown to be within normal ranges before inclusion into the study.
∙ 8\. No evidence (\< 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin).
∙ 9\. Able to adhere to the study visit schedule and other protocol requirements.