Study of ODX (OsteoDex) in Multiple Myeloma

NCT06616389 | Recruiting Phase 1 DMC

• 1 other identifier: ODX-MM-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• To determine the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] in subjects with relapsed/refractory multiple myeloma myeloma.

  Number of participants with AEs/SAEs, with abnormal vital signs, abnormal physical examination findings, abnormal ECG readings, and abnormal results of urinalysis and safety laboratory tests (haematology, electrolytes, liver function, and biochemistry including S/P-Creatinine and S/P-Cystatin C)

  During the 14 week treatment/follow up period

Secondary Outcomes (2)

• To evaluate the preliminary efficacy of ODX, as determined by the IMWG response criteria, in subjects with relapsed/refractory multiple myeloma.

  During the 14 week treatment/follow up period

• 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.

  During the 14 week treatment/follow up period

Study Arms (1)

Ascending dose

OTHER

Each subject will receive ODX treatment at 2-week intervals up to a maximum of 7 doses or until disease progression or unacceptable toxicity. The trial will consist of the following periods: Screening period (V0) Treatment period (V1 to V9, which includes 2 telephone contacts) Follow-up period (V10) The dose cohorts will be studied sequentially as follows: Dose cohort 1: 3.0 mg/kg ODX Dose cohort 2: 6.0 mg/kg ODX Dose cohort 3: 9.0 mg/kg ODX A dose escalation meeting will be called when data are available for Visit 4 of the 4th subject in a cohort. Based on the review of the safety data, the DMC will give recommendations regarding assessment of DLTs and dose escalation.

Drug: ODX (Osteodex)

Interventions

ODX (Osteodex) DRUG

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

Ascending dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subject (male or female) is ≥ 18 years of age at the time of signing the informed consent form (ICF).
• \. Documented diagnosis av multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria.
• \. Measurable disease defined as either:
• Serum monoclonal paraprotein (M-protein) level ≥ 0.5 g/dL or urine M-protein level ≥ 200 mg/24 hours; or
• Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain (FLC) ≥ 10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
• \. Subjects must have received 1-5 prior lines of therapy including a PI, IMiD and CD38 antibody\*.
• \. Subjects must have documented evidence of progressive disease based on the IMWG criteria on or after their last line of therapy.
• \. Performance status ECOG 0-2 7. Laboratory requirements:
• Haematology:
• Neutrophils ≥ 1.0 x 109/l Hemoglobin ≥ 80 g/l Platelets ≥ 50 x 109/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:

You may not qualify if:

• Concurrent use of other anti-cancer agents/treatments.
• Any treatment modalities involving chemotherapy, radiation, or major surgery within 4 weeks prior to treatment in this study.
• Simultaneous participation in any other study involving investigational drugs or having participated in an investigational study less than 4 weeks prior to start of study treatment.
• Any condition, including the presence of laboratory abnormalities, which confounds the ability to interpret data from the study or places the patient at unacceptable risk if he or she participates in the study.
• Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
• Plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome.
• Dental surgery (dental extraction), periodontal disease, local trauma including poorly fitting dentures within 6 months prior to the first dose of study drug.
• Treatment with bisphosphonates or denosumab within 6 weeks prior to first dose of study medication.
• Male subjects not willing to use condom to prevent pregnancy and drug exposure of a fertile female partner and refrain from donating sperm from the date of the first dose until the end of study treatment.
• Pregnant or breastfeeding females.
• Female subjects of childbearing potential\*\* not willing to use a contraceptive method with a failure rate of \< 1% to prevent pregnancy during study treatment. Highly effective birth control methods include:
• combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
• oral
• intravaginal
• transdermal

Sponsors & Collaborators

• DexTech Medical AB: lead

Study Sites (2)

Karolinska Universitetssjukhuset Huddinge Cancerstudieenheten M62

Stockholm, 14186, Sweden

RECRUITING

Uddevalla Sjukhus, Hematologens dagvård

Uddevalla, 45180, Sweden

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Anders Holmberg

  DexTech Medical AB

  STUDY CHAIR

Central Study Contacts

Anders Holmberg, Med DR

CONTACT

0046 73 324 2782; arh@telia.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Ascending dose study to evaluate safety and biological efficacy of up to 3 dose levels of ODX

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 27, 2024
• Study Start: November 29, 2023
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)