Multiple myeloma MedDRA version: 21.1 Level: LLT Classification code 10067095 Term: Multiple myeloma progression System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Osteodex
Product Code: ODX
Pharmaceutical Form: Solution for infusion
Sponsors
DexTech Medical AB
Eligibility
Sex/Gender
All
Inclusion criteria
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-creatinine = 1.5 times ULN Electrolytes: S/P-sodium, S/P-potassium, S/P-calcium corrected for S/P albumin corrected, 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 (=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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: o oral o intravaginal o transdermal • progestogen-only hormonal contraception associated with inhibition of ovulation: o oral o injectable o 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To determine the safety and tolerability of ODX in subjects with relapsed/refractory multiple myeloma.;Secondary Objective: •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 ;Primary end point(s): Occurrence of AEs/SAEs, vital signs, physical examination, ECG, and the results of urinalysis and safety laboratory tests (haematology, electrolytes, liver function, and biochemistry including S/P-Creatinine and S/P-Cystatin C). Note that the primary endpoints will be used to confirm the safety and tolerability of ODX in the patient population and no statistical testing will be performed for these endpoints. ;Timepoint(s) of evaluation of this end point: After subject has signed informed consent and during participation in the study until final follow-up visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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. -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. -Change in Quality of Life (QoL) scores, as measured by the EQ-5D-5L assessment tool, from baseline to Weeks 2, 8, and 14. Change in the mean EQ-5D-5L Visual Analogue Scale (VAS) score from baseline to Weeks 2, 8, and 14. ;Timepoint(s) of evaluation of this end point: -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. -Change in Quality of Life (QoL) scores, as measured by the EQ-5D-5L assessment tool, from baseline to Weeks 2, 8, and 14. Change in the mean EQ-5D-5L Visual Analogue Scale (VAS) score from baseline to Weeks 2, 8, and 14. | — |
Countries
Sweden
Contacts
Public ContactEva Taliveer Hedin
Scandinavian CRO AB
Outcome results
None listed