NCT06616389

Study of ODX (OsteoDex) in Multiple Myeloma

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: DexTech Medical AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-29
• Primary completion: 2026-01-30
• Completion: 2026-01-30
• First posted: 2024-09-27
• Last updated: 2025-08-19

Locations

2 sites across 1 country: Sweden