Clinical 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
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• Patients must have newly diagnosed ultra high-risk disease, as defined by one of the following:1)Double hitMultiple 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.
• Patients must be either untreated or have not received systemic MM therapy. Prior bisphosphonates and localized radiation are allowed.
• Aged 18 years to 70 years.
• Fit for intensive chemotherapy and autologous stem cell transplant (at clinician's discretion).
• Eastern Cooperative Oncology Group (ECOG) score ≤2 before induction chemotherapy.
Locations
Other Locations
China
Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology