Multiple MyelomaPhase 1/2NCT06616389
Study of ODX (OsteoDex) in Multiple Myeloma
A Phase 1/2 study testing ODX (Osteodex) in people with Multiple Myeloma, run by DexTech Medical AB at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- ODX (Osteodex)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesSweden
- Study dates
- 29 Nov 2023to 30 Jan 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
- 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.
- Subjects in which pre-medication with dexamethasone, antihistamine, and paracetamol would be contraindicated.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Karolinska Universitetssjukhuset Huddinge Cancerstudieenheten M62
Stockholm, 14186
Katarina Uttervall, MD, PhD, +46 724694954, katarina.uttervall@regionstockholm.se
Katarina Uttervall
- Recruiting
Uddevalla Sjukhus, Hematologens dagvård
Uddevalla, 45180
Dorota Knut, MD, +46 10 4354701, Dorota.knut@vgregion.se
Dorota Knut
About this study
Official title: 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:
Read more
- 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
- Being tested
- ODX (Osteodex)
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: ODX (Osteodex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
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.
Measured: 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.
Measured: During the 14 week treatment/follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start29 Nov 2023
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Ascending dose study to evaluate safety and biological efficacy of up to 3 dose levels of ODX
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DexTech Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anders Holmberg, Study chair, DexTech Medical AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616389
- Sponsor's protocol ID
- ODX-MM-001
- Status last verified
- Aug 2025
- First submitted
- 2 Sep 2024
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Study of ODX (OsteoDex) in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06616389
- Acronym / sponsor ID
- ODX-MM-001
- Conditions
- Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- DexTech Medical ABIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Ascending dose study to evaluate safety and biological efficacy of up to 3 dose levels of ODX
| Arm | Type | Receives |
|---|---|---|
| Ascending dose | Other | Drug: ODX (Osteodex)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ODX (Osteodex)Multi-center, prospective, open-label, ascending dose study to evaluate safety and biological efficacy of up to 3 dose levels of ODX. | Drug | Ascending dose |
Primary outcome
To determine the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] in subjects with relapsed/refractory multiple myeloma myeloma.
Time frame: During the 14 week treatment/follow up period
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)
2 secondary outcomes
To evaluate the preliminary efficacy of ODX, as determined by the IMWG response criteria, in subjects with relapsed/refractory multiple myeloma.
Time frame: 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.
Time frame: During the 14 week treatment/follow up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anders Holmberg study chair
DexTech Medical AB
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ODX (Osteodex) in people with Multiple Myeloma, run by DexTech Medical AB at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anders Holmberg, Med DR (0046 73 324 2782, arh@telia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] in subjects with relapsed/refractory multiple myeloma myeloma. (time frame: During the 14 week treatment/follow up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.