An observational study in Newly Diagnosed Multiple Myeloma, sponsored by The First Affiliated Hospital of Soochow University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by The First Affiliated Hospital of Soochow University · Observational
This is an open-label, single-arm, prospective study conducted in real-world clinical practice. It aims to evaluate the efficacy and safety in Chinese patients with newly diagnosed multiple myeloma who switch to carfilzomib-based regimens after bortezomib-based triple-drug regimen intolerance happens.
This is an open-label, single-arm, prospective study conducted in real-world clinical practice. Chinese patients with newly diagnosed multiple myeloma will be enrolled if they switch to carfilzomib-based regimens after bortezomib-based triple-drug regimen intolerance happens.
Induction and consolidation therapy will be 6-8cycles. 6 cycles for transplant recipients and 8 cycles for non-transplant recipients. Maintenance therapy will continue until progression.
It aims to evaluate the efficacy and safety of carfilzomib based therapy in Chinese NDMM patients with intolerance to bortezomib. The primary endpoint is the rate of 2-year pFS and secondary endpoints are the rate of ORR,sCR/CR,VGPR,PR, the rate and duration of MRD, the rate of 2-year OS and safety.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's planned enrollment of 50 is below the median of 140 across 468 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Newly diagnosed multiple myeloma patients who develop toxicities associated with bortezomib therapy evaluated by the investigator, including the presence of Grade 1 with pain or Grade 2 peripheral neuropathy (PN), Grade 3 hepatic impairment, Grade 3 diarrhea, and any other Grade 3 non-hematologic adverse events
Exclusion Criteria:
if bortezomib related intolerance happens during front line therapy of bortezomib-based triple regimen, then carfilzomib-based therapy will be used
Drug: Carfilzomib
carfilzomib C1: 20mg/m2,D1-2; 27mg/m2,D8-9; 36mg/m2,D15-16 C2 and subsequent cycles: 36mg/m2。
Also known as: Kyprolis
Outcome of peripheral neuropathy
recurrence of peripheral neuropathy
Time frame: from enrollment to 2 years
ORR
the rate of sCR,CR, PR and VGPR according to IMWG(International Myeloma Working Group) criteria
Time frame: from enrollment to 2 years
sCR/CR rate
the rate of sCR/CR according to IMWG criteria
Time frame: from enrollment to 2 years
PR rate
the rate of PR according to IMWG criteria
Time frame: from enrollment to 2 years
VGPR rate
the rate of VGPR according to IMWG criteria
Time frame: from enrollment to 2 years
MRD negativity rate
the rate of minimal residual disease
Time frame: from enrollment to 2 years
AE rate
the rate of adverse events
Time frame: from enrollment to 2 years
2-year OS rate
the rate of Overall survival at 2 years
Time frame: from enrollment to 2 years
Duration of MRD negativity
Duration of minimal residual disease negativity
Time frame: from enrollment to 2 years
2-year PFS rate
the rate of progression free survival at 2 years
Time frame: from enrollment to 2 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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The First Affiliated Hospital of Soochow University