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RECRUITING
NCT06616389
PHASE1/PHASE2

Study of ODX (OsteoDex) in Multiple Myeloma

Sponsor: DexTech Medical AB

View on ClinicalTrials.gov

Summary

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

Official title: A Phase I/IIa Study of ODX (OsteoDex) in Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2023-11-29

Completion Date

2026-01-30

Last Updated

2025-08-19

Healthy Volunteers

No

Interventions

DRUG

ODX (Osteodex)

Multi-center, prospective, open-label, ascending dose study to evaluate safety and biological efficacy of up to 3 dose levels of ODX.

Locations (2)

Karolinska Universitetssjukhuset Huddinge Cancerstudieenheten M62

Stockholm, Sweden

Uddevalla Sjukhus, Hematologens dagvård

Uddevalla, Sweden