Study of ODX (OsteoDex) in Multiple Myeloma

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

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

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: ODX (Osteodex)

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Anders Holmberg, Med DR; Phone Number: 0046 73 324 2782; Email: arh@telia.com

Study Locations

• Sweden
  • Stockholm, Sweden, 14186
    • Recruiting
    • Karolinska Universitetssjukhuset Huddinge Cancerstudieenheten M62
    • Principal Investigator: Katarina Uttervall
    • Contact: Katarina Uttervall, MD, PhD; Phone Number: +46 724694954; Email: katarina.uttervall@regionstockholm.se
  • Uddevalla, Sweden, 45180
    • Recruiting
    • Uddevalla Sjukhus, Hematologens dagvård
    • Contact: Dorota Knut, MD; Phone Number: +46 10 4354701; Email: Dorota.knut@vgregion.se
    • Principal Investigator: Dorota Knut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Subject (male or female) is ≥ 18 years of age at the time of signing the informed consent form (ICF).

  2. Documented diagnosis av multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria.

  3. 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.

    4. Subjects must have received 1-5 prior lines of therapy including a PI, IMiD and CD38 antibody*.

    *Patients eligible for inclusion should have received said treatments, i.e., according to clinical routine, unless contraindicated due to induced morbidity.

    5. Subjects must have documented evidence of progressive disease based on the IMWG criteria on or after their last line of therapy.

    6. 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:

S/P-sodium, S/P-potassium, S/P-calcium corrected for S/P albumin , S/P-phosphate, and S/P magnesium, all within normal ranges. At the discretion of the Investigator, supplements may be given to correct these values, in which case electrolytes must be shown to be within normal ranges before inclusion into the study.

8. No evidence (< 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin).

9. Able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

1. Concurrent use of other anti-cancer agents/treatments.
2. Any treatment modalities involving chemotherapy, radiation, or major surgery within 4 weeks prior to treatment in this study.
3. 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.
4. 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.
5. Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
6. Plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome.
7. Dental surgery (dental extraction), periodontal disease, local trauma including poorly fitting dentures within 6 months prior to the first dose of study drug.
8. Treatment with bisphosphonates or denosumab within 6 weeks prior to first dose of study medication.
9. 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.
10. Pregnant or breastfeeding females.

11. 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

    • progestogen-only hormonal contraception associated with inhibition of ovulation:

      • oral
      • injectable
      • implantable
    • intrauterine device
    • intrauterine hormone-releasing system (for example, progestin-releasing coil)
    • vasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate)
    • bilateral tubal occlusion or hysterectomy. **Female subjects are considered of non-childbearing potential if they are pre-menopausal females with a documented tubal ligation or hysterectomy or bilateral oophorectomy; or as post-menopausal females defined as at least 12 months of amenorrhea.
12. Subjects in which pre-medication with dexamethasone, antihistamine, and paracetamol would be contraindicated.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the preliminary efficacy of ODX, as determined by the IMWG response criteria, in subjects with relapsed/refractory multiple myeloma.	Best overall response rate (partial response [PR] or better) reached during the 14-week treatment/follow-up period, as measured by the IMWG response criteria.	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.	Change in the levels of the serum biomarkers M-protein, FLC, CTX, osteocalcin, and bone-specific S ALP from baseline to Weeks 2, 4, 6, 8, 10, 12, and 14.	During the 14 week treatment/follow up period

Collaborators and Investigators

• Sponsor: DexTech Medical AB
• Investigators: Study Chair: Anders Holmberg, DexTech Medical AB

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2023
• Primary Completion (Estimated): January 30, 2026
• Study Completion (Estimated): January 30, 2026

Study Registration Dates

• First Submitted: September 2, 2024
• First Submitted That Met QC Criteria: September 24, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: ODX-MM-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No