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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
Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
54
Start Date
2023-10-20
Completion Date
2027-10-20
Last Updated
2025-04-16
Healthy Volunteers
No
Interventions
Daratumumab
Given by vein: days 1 and 8 of each Induction cycle; days 1 and 15 of each Consolidation cycle; and day 1of each Maintenance cycle.
Carfilzomib
Given by vein: days 1,2,8 and 9 of each Induction cycle; days 1, 2, 8, 9,15, and 16 of each Consolidation cycle; days 1, 2,15, and 16 of each Maintenance cycle.
Lenalidomide
Given by mouth: days 1-7 of each Induction cycle; days 1-14 of each Consolidation cycle.
Dexamethasone
Given by mouth or by vein: days 1, 8, 15, and 22 of each Induction cycle; days 1, 8, 15, and 22 of each Consolidation cycle; and days 1 and 15 of every cycle during Maintenance
Cisplatin
Given by vein: days 1-4 of each Induction cycle
epirubicin
Given by vein: days 1-4 of each Induction cycle
Cyclophosphamide
Given by vein: days 1-4 of each Induction cycle
Etoposide
Given by vein: days 1-4 of each Induction cycle
Melphalan
Given by vein: day -1 of Transplant
ASCT
day 0 of Transplant
bortezomib
given by subcutaneous injection: days 1, 4, 8, and 11 of pretrial induction chemotherapy
Locations (1)
Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China