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Study of ODX (OsteoDex) in Multiple Myeloma

NCT06616389 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-08-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • DexTech Medical AB

    lead INDUSTRY

Principal Investigators

  • Anders Holmberg · DexTech Medical AB

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-29
Primary Completion
2026-01-30
Completion
2026-01-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06616389 on ClinicalTrials.gov