OncoMatch/Clinical Trials/NCT06616389
Study of ODX (OsteoDex) in Multiple Myeloma
Is NCT06616389 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies ODX (Osteodex) for multiple myeloma.
Treatment: ODX (Osteodex) — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: proteasome inhibitor
Subjects must have received 1-5 prior lines of therapy including a PI, IMiD and CD38 antibody*.
Must have received: immunomodulatory drug
Subjects must have received 1-5 prior lines of therapy including a PI, IMiD and CD38 antibody*.
Must have received: CD38 antibody
Subjects must have received 1-5 prior lines of therapy including a PI, IMiD and CD38 antibody*.
Cannot have received: chemotherapy
Any treatment modalities involving chemotherapy, radiation, or major surgery within 4 weeks prior to treatment in this study.
Cannot have received: radiation therapy
Any treatment modalities involving chemotherapy, radiation, or major surgery within 4 weeks prior to treatment in this study.
Cannot have received: major surgery
Any treatment modalities involving chemotherapy, radiation, or major surgery within 4 weeks prior to treatment in this study.
Cannot have received: bisphosphonate
Treatment with bisphosphonates or denosumab within 6 weeks prior to first dose of study medication.
Cannot have received: RANKL inhibitor (denosumab)
Treatment with bisphosphonates or denosumab within 6 weeks prior to first dose of study medication.
Lab requirements
Blood counts
Neutrophils 1.0 x 10^9/l; Hemoglobin 80 g/l; Platelets 50 x 10^9/l
Kidney function
S/P-creatinine 1.5 times ULN
Liver function
Total S/P-bilirubin 1.5 times the upper limit of normal (ULN); AST (SGOT) / ALT (SGPT) 2.5 times ULN
Haematology: Neutrophils 1.0 x 10^9/l Hemoglobin 80 g/l Platelets 50 x 10^9/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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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