Multiple Myeloma
Conditions
Brief summary
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.
Detailed description
• 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.• Quality of Life (QoL) scores, as measured by the EQ-5D-5L assessment tool, from baseline to Weeks 2, 8, and 14
Interventions
DRUGOsteoDex
Sponsors
Dextech Medical AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| • 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.• Quality of Life (QoL) scores, as measured by the EQ-5D-5L assessment tool, from baseline to Weeks 2, 8, and 14 | — |
Countries
Sweden
Outcome results
None listed