HOVON503/EMN24
Phase III study of Isatuximab-Carfilzomib-Lenalidomide-Dexamethasone (Isa-KRd) versus Carfilzomib-Lenalidomide-Dexamethasone (KRd) in newly diagnosed multiple myeloma patients eligible for autologous stem cell transplantation (IsKia TRIAL)
Study treatments
- Arm A:Isatuximab-carfilzomib-lenalidomidedexamethasone for 4 cycles followed by ASCT
- Arm B:carfilzomib-lenalidomidedexamethasone for 4 cycles followed by ASCT
Inclusion criteria
- Patient with newly diagnosed multiple myeloma and eligible to ASCT.
- Monoclonal plasma cells in the bone marrow ≥10% or presence of a biopsy proven plasmacytoma and documented multiple myeloma satisfying at least one of the calcium, renal, anemia, bone (CRAB) criteria or biomarkers of malignancy criteria:
- Patient is 18 - 70 years old and is eligible for autologous stem cell transplantation
- Patient has measurable disease
- ECOG status ≤2
Exclusion criteria
- Previous treatment with anti-myeloma therapy (does not include radiotherapy, biphosphonates, or a single short course of steroid ≤ to the equivalent of dexamethasone 40 mg/day for 4 days).
- Patients with non-secretory MM unless serum free light chains are present and the ratio is abnormal or a plasmacytoma with minimum largest diameters of > 2 cm.
- Patients with plasma cell leukemia, amyloidosis, Waldenstrom Disease, POEMS syndrome
Participating sites
- ZNA Antwerpen