TitleA multicenter, open label phase II study of isatuximab, ixazomib and low dose dexamethasone in a cohort of intermediate fit and in a cohort of frail newly diagnosed multiple myeloma (MM) patients.
Overview / Summary
This is a study conducted in Italy, involving 20 sites. The aim is to determine the efficacy and feasibility of 9 cycles of ixazomib, daratumumab and low dose dexamethasone followed by ixazomib and daratumumab maintenance until progression for a maximum of 2 years in unfit and frail NDMM patients
Patient eligibility criteria
- Previously untreated patients with a confirmed diagnosis of multiple myeloma (MM) according to IMWG criteria (see Appendix A);
- Life-expectancy ≥ 3 months;
- Measurable disease according to the IMWG criteria (see Appendix A); (If plasmacytoma is the only measurable parameter, the patient is not allowed to be included in the study, because of difficult response evaluation);
- Patients who are either intermediate fit or frail according to the IMWG criteria (see Appendix B);
- Age 18 years or older;
- Absolute neutrophil count (ANC) ≥ 1.0 x109/l and platelet count ≥ 75×109/l;
- Platelet transfusions and G-CSF to help patients meet eligibility criteria are not allowed.