OSTEODEX for Multiple myeloma|Relapsed/refractory multiple myeloma

Inclusion criteria

• {"criterion_text":"- 1.\tSubject (male or female) is ≥ 18 years of age at the time of signing the informed consent form (ICF).\n- 2.\tDocumented diagnosis av multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria.\n- 3.\tMeasurable disease defined as either: •\tSerum monoclonal paraprotein (M-protein) level ≥ 0.5 g/dL or urine M-protein level ≥ 200 mg/24 hours; or •\tLight 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.\n- 4.\tSubjects must have received 1-5 prior lines of any therapy\n- 5.\tSubjects must have documented evidence of progressive disease based on the IMWG criteria on or after their last line of therapy.\n- 6.\tPerformance status ECOG 0-2\n- 7.\tLaboratory 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.\n- 8.\tNo evidence (< 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin).\n- 9.\tAble to adhere to the study visit schedule and other protocol requirements."}

Exclusion criteria

• {"criterion_text":"- 1.\tConcurrent use of other anti-cancer agents/treatments.\n- 2.\tAny treatment modalities involving chemotherapy, radiation, or major surgery within 4 weeks prior to treatment in this study.\n- 3.\tSimultaneous 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.\n- 4.\tAny 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.\n- 5.\tKnown active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.\n- 6.\tPlasma cell leukemia, Waldenstrom’s macroglobulinemia or POEMS syndrome.\n- 7.\tDental surgery (dental extraction), periodontal disease, local trauma including poorly fitting dentures within 6 months prior to the first dose of study drug.\n- 8.\tTreatment with bisphosphonates or denosumab within 6 weeks prior to first dose of study medication.\n- 9.\tMale 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.\n- 10.\tPregnant or breastfeeding females.\n- 11.\tFemale 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: •\tcombined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: o\toral o\tintravaginal o\ttransdermal •\tprogestogen-only hormonal contraception associated with inhibition of ovulation: o\toral o\tinjectable o\timplantable •\tintrauterine device •\tintrauterine hormone-releasing system (for example, progestin-releasing coil) •\tvasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate) •\tbilateral 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.\n- 12. Subjects in which pre-medication with dexamethasone, antihistamine, and paracetamol would be contraindicated."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint parameters are 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.","definition_or_measurement_approach":"Occurrence and monitoring of adverse events (AEs/SAEs), vital signs, physical examination findings, ECG recordings, urinalysis, and safety laboratory tests (haematology, electrolytes, liver function, biochemistry including S/P-Creatinine and S/P-Cystatin C). These parameters are used to assess safety and tolerability; no statistical testing will be performed for these endpoints."}

Secondary endpoints

• {"endpoint_text":"- •\tBest overall response rate (partial response [PR] or better) reached during the 14-week treatment/follow-up period, as measured by the IMWG response criteria.\n- •\tChange 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.\n- •\tQuality of Life (QoL) scores, as measured by the EQ-5D-5L assessment tool, from baseline to Weeks 2, 8, and 14","definition_or_measurement_approach":"Best overall response rate measured by IMWG response criteria during a 14-week treatment/follow-up period; biomarker changes measured from baseline to specified weeks (Weeks 2,4,6,8,10,12,14); QoL measured using EQ-5D-5L from baseline to Weeks 2, 8, and 14."}

Sweden

Earliest CTIS Part Ii Submission Date

05-09-2024

Latest Decision Or Authorization Date

24-01-2025

Processing Time Days

141

Number Of Sites

2

Number Of Participants

12

Primary sponsor

Full Name

Dextech Medical AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden