Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction/Consolidation/Maintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma
Trial Parameters
Brief Summary
This study will assess whether the combination of daratumumab and carfilzomib-based Induction/Consolidation/Maintenance Therapy with ASCT improves the outcome of patients with ultra high-risk, newly diagnosed multiple myeloma
Eligibility Criteria
Inclusion Criteria: 1. Patients must have newly diagnosed ultra high-risk disease, as defined by one of the following:1)"Double hit"Multiple Myeloma (≥2 adverse markers: t(4;14), t(14;16), t(14;20), 1q21+, del(17p),p53 mutation) ,2)Extramedullary Multiple Myeloma, 3) primary plasma cell leukemia. 2. Patients must be either untreated or have not received systemic MM therapy. Prior bisphosphonates and localized radiation are allowed. 3. Aged 18 years to 70 years. 4. Fit for intensive chemotherapy and autologous stem cell transplant (at clinician's discretion). 5. Eastern Cooperative Oncology Group (ECOG) score ≤2 before induction chemotherapy. Exclusion Criteria: 1. No evidence of high-risk disease. 2. Primary diagnosis of Waldenstrom's disease/POEMS syndrome/light chain amyloidosis. 3. Received therapy for multiple myeloma. 4. Prior or concurrent invasive malignancies. 5. Eastern Cooperative Oncology Group (ECOG) score \>2 before induction chemotherapy. 6. Clinically significant allergi