About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 18 years of age
Diagnosed with multiple myeloma according to IMWG criteria.
Patients who have received only first-line bortezomib-based triple therapy, including bortezomib/lenalidomide/dexamethasone (VRD), bortezomib/thalidomide/dexamethasone (VTD),bortezomib/ cyclophosphamide/dexamethasone (VCD), and bortezomib/adriamycin//dexamethasone (PAD).
Eastern cooperative oncology group(ECOG) score 0-2
Disqualifiers
Patients currently participating in other interventional clinical studies (except those currently participating in non-interventional observational studies)
Patients who have received prior carfilzomib treatment or participated in carfilzomib associated studies (with or without carfilzomib treatment).
Patients with a primary diagnosis of MM combined with plasma cell leukemia (peripheral blood monoclonal plasma cells ≥5% of the total number of differentiated mature leukocytes)
Patients who have not fully recovered from the reversible effects of prior chemotherapy (i.e., <= grade 1 toxicity).
Trial population
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
Trial design
Cohort
Prospective
Treatments tested in this trial
Carfilzomib
Drugcarfilzomib C1: 20mg/m2,D1-2; 27mg/m2,D8-9; 36mg/m2,D15-16 C2 and subsequent cycles: 36mg/m2。
Treatment groups
Trial outcomes
Primary outcomes
Outcome of peripheral neuropathy
recurrence of peripheral neuropathy
Secondary outcomes
ORR
the rate of sCR,CR, PR and VGPR according to IMWG(International Myeloma Working Group) criteria
sCR/CR rate
the rate of sCR/CR according to IMWG criteria
PR rate
the rate of PR according to IMWG criteria
VGPR rate
the rate of VGPR according to IMWG criteria
Sponsors and contacts
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