The purpose of this study is to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome injection in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma.
This is a multicenter, open-label, phase I study aimed to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome injection in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma. In the study, 60 patients will be recruited into three dose groups. All patients will receive the treatment for the planned 8 cycles(28 days per cycle)until disease progression or unacceptable drug-related adverse events
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Mitoxantrone Hydrochloride Liposome injection will be administered by an intravenous infusion on day 1 of each 28-day cycle
Bortezomib (1.3 mg/m\^2) will be administered by an intravenous injection or subcutaneously on day 1,4,8,11of each 28-day cycle
Dexamethasone (20 mg/d) will be taken orally on day 1,2,4,5,8,9,11,12 of each 28-day cycle
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGTreatment-emergent adverse events (TEAEs)
To indentify the incidence of TEAEs
Time frame: From the initiation of the first dose to 28 days after the last dose
Objective response rate (ORR)
ORR is defined as the proportion of patients who have a best overall response of partial response (PR),very good partial response(VGPR), complete response (CR) or stringent complete response (sCR) as per International Myeloma Working Group (IMWG)
Time frame: Throughout the study treatment(Up to 32 weeks)
Clinical Benefit Rate(CBR)
CBR is defined as the proportion of patients who have a best overall response of minimal response(MR),PR,VGPR,CR or sCR as per IMWG
Time frame: Throughout the study treatment(Up to 32 weeks)
Disease control rate(DCR)
DCR is defined as the proportion of patients who have a best overall response of stable disease (SD),MR,PR,VGPR,CR or sCR as per IMWG
Time frame: Throughout the study treatment(Up to 32 weeks)
Duration of response (DoR)
DoR is defined as the time from the first assessment of PR,VGPR,CR orsCR until the date of first occurrence of progressive disease (PD) as per IMWG
Time frame: Throughout the study completion.(An average of 12 months)
Progression-free survival (PFS)
PFS is defined as the time from the date of first dose until the date of first documented PD as per IMWG or death from any cause, whichever occurs first
Time frame: Throughout the study completion.(An average of 12 months)
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Overall survival (OS)
OS is defined as the time from the date of first dose until the date of death from any cause
Time frame: Throughout the study completion.(An average of 36 months)