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
Survival outcomes for patients with newly diagnosed multiple myeloma (MM) have improved substantially in the past decades, due to the introduction of novel therapeutic strategies. Unfortunately, patients with ultra-high-risk MM, including "double-hit" MM, extramedullary MM (EMM), and primary plasma cell leukemia (pPCL), have a significantly worse prognosis and benefit less from current therapeutic strategies. This study aims to investigate whether a treatment regimen combining daratumumab and carfilzomib-based Induction/Consolidation/Maintenance Therapy with autologous stem cell transplantation (ASCT) can improve the survival outcomes of newly diagnosed, transplant-eligible, ultra high-risk multiple myeloma patients. In the study, participants will receive induction therapy with 2-4 cycles of Dara-KRd-PACE, followed by ASCT, 4 cycles of Dara-KRd consolidation, and then maintenance with 12 cycles of Dara-Kd.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
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.
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.
Given by mouth: days 1-7 of each Induction cycle; days 1-14 of each Consolidation cycle.
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
Given by vein: days 1-4 of each Induction cycle
Given by vein: days 1-4 of each Induction cycle
Given by vein: days 1-4 of each Induction cycle
Given by vein: days 1-4 of each Induction cycle
Given by vein: day -1 of Transplant
day 0 of Transplant
given by subcutaneous injection: days 1, 4, 8, and 11 of pretrial induction chemotherapy
Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITING2-year progression-free survival
2-year Progression-free survival of participants as determined by investigator assessment.
Time frame: 24 months
progression-free survival
progression-free survival of participants as determined by investigator assessment.
Time frame: 36 months
overall survival
overall survival of participants as determined by investigator assessment.
Time frame: 36 months
overall response rate
Overall response rate as determined by the 2016 International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma and 2013 IMWG Response Criteria for Plasma cell leukemia by Independent Review Committee (IRC) and investigator assessment.
Time frame: 36 months
minimal residual disease negativity rate
Minimal Residual Disease (MRD) negativity rate as assessed by next generation sequencing.
Time frame: 36 months
complete response rate
complete response rate as determined by the 2016 International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma and 2013 IMWG Response Criteria for Plasma cell leukemia by Independent Review Committee (IRC) and investigator assessment.
Time frame: 36 months
duration of minimal residual disease negativity
determined by the 2016 International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma and 2013 IMWG Response Criteria for Plasma cell leukemia by Independent Review Committee (IRC) and investigator assessment.
Time frame: 36 months
duration of response
determined by investigator assessment.
Time frame: 36 months
adverse events
graded according to the Common Terminology Criteria for Adverse Events v5
Time frame: collected until 3 months after treatment completion
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