Actively Recruiting
Study of ODX (OsteoDex) in Multiple Myeloma
Led by DexTech Medical AB · Updated on 2025-08-19
12
Participants Needed
2
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Study of ODX (OsteoDex) in Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at the time of consent
- Documented diagnosis of multiple myeloma per International Myeloma Working Group criteria
- Measurable disease defined by serum M-protein 0.5 g/dL, urine M-protein 200 mg/24 hours, or light chain multiple myeloma with serum free light chain 10 mg/dL and abnormal kappa/lambda ratio
- Received 1 to 5 prior lines of therapy including a proteasome inhibitor, immunomodulatory drug, and CD38 antibody, unless contraindicated
- Documented progressive disease after last therapy per IMWG criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Laboratory values within specified hematology, hepatic, renal, and electrolyte ranges
- No prior malignancies within 5 years except treated basal or squamous cell skin carcinoma
- Ability to follow study visit schedule and protocol requirements
You will not qualify if you...
- Concurrent use of other anti-cancer treatments
- Chemotherapy, radiation, or major surgery within 4 weeks prior to study treatment
- Participation in other investigational drug studies within 4 weeks prior to treatment
- Conditions or lab abnormalities that interfere with study data or increase risk
- Known active central nervous system involvement or meningeal signs of multiple myeloma
- Diagnosis of plasma cell leukemia, Waldenstrom's macroglobulinemia, or POEMS syndrome
- Dental surgery, periodontal disease, or local oral trauma within 6 months prior to first dose
- Treatment with bisphosphonates or denosumab within 6 weeks before first dose
- Male subjects unwilling to use condoms and avoid sperm donation during treatment
- Pregnant or breastfeeding females
- Female subjects of childbearing potential unwilling to use highly effective contraception during treatment
- Contraindication to pre-medication with dexamethasone, antihistamine, or paracetamol
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Karolinska Universitetssjukhuset Huddinge Cancerstudieenheten M62
Stockholm, Sweden, 14186
Actively Recruiting
2
Uddevalla Sjukhus, Hematologens dagvård
Uddevalla, Sweden, 45180
Actively Recruiting
Research Team
A
Anders Holmberg, Med DR
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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