Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT03042793
Eligibility Criteria:
Inclusion Criteria:
1. Histologically verified multiple myeloma
2. Newly treated with HDT and no signs of relapse
3. Age ≥18 years
4. Performance status ≤ 2 (ECOG-scale)
5. Expected survival \> 3 months
6. Sufficiently regenerated bone marrow function, i.e.
1. Leucocytes ≥ 1,5 x 109
2. Granulocytes ≥ 1,0 x 109
3. Thrombocytes ≥ 20 x 109
7. Creatinine \< 2.5 upper normal limit, i.e. \< 300 μmol/l
8. Sufficient liver function, i.e.
1. ALAT \< 2.5 upper normal limit, i.e. ALAT \<112 U/l
2. Bilirubin \< 30 U/l
9. Women agreement to use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for at least 120 days after the last treatment.
10. For men: agreement to use contraceptive measures and agreement to refrain from donating sperm.
Exclusion Criteria:
1. Non-secretory myeloma
2. Other malignancies in the medical history excluding squamous cell carcinoma of the skin and patients cured for another malignant disease with no sign of relapse three years after ended treatment.
3. Significant medical condition per investigators judgement e.g. severe Asthma/COPD, poorly regulated heart condition, insulin dependent diabetes mellitus.
4. Acute or chronic viral infection e.g. HIV, hepatitis or tuberculosis
5. Serious known allergies or earlier anaphylactic reactions.
6. Known sensibility towards Montanide ISA-51
7. Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc.
8. Pregnant and breastfeeding women.
9. Fertile women not using secure contraception with a failure rate less than \< 1%
10. Patients taking immune suppressive medications incl. corticosteroids and methotrexate at the time of enrollment
11. Psychiatric disorders that per investigator judgment could influence compliance.
12. Treatment with other experimental drugs
13. Treatment with other anti-cancer drugs - except bisphosphonates and denosumab
14. Patients with active uncontrolled hypercalcemia
15. Patients who have received chemotherapy, immune therapy, radiation therapy within the last 28 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03042793
Study Brief:
Protocol Section:
NCT03042793