This is a first-in-human study to investigate the safety, tolerability, pharmacokinetics, and efficacy of Bisthianostat in refractory or recurrent multiple myeloma patients.
This is a first-in-human, single center, open-label, single arm, dose escalating phase I study. This study will be conducted in 3 parts. Phase A : Patients will receive single dose of bisthianostat to evaluate the single-dose pharmacokinetics and safety. Phase B: After single-dose phase, patients will receive multiple dose bisthianostat for 4 weeks on day 1,4,11,14,18,21,25,28 to evaluate the multiple-dose pharmacokinetics and safety Phase C: Patients will continue on the study if they benefit from the drug and not experience any serious side effects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Bisthianostat is a histone deacetylase inhibitor (HDAC inhibitor) for the treatment of multiple myeloma.
Renji Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGMaximum tolerated dose of Bisthianostat
To determine the maximum tolerated dose of Bisthianostat in refractory or recurrent multiple myeloma patients.
Time frame: Up to 24 months
Treatment-related adverse events considered as dose-limiting toxicity
To evaluate the severity of treatment-related AEs considered as dose-limiting toxicity.
Time frame: During the first cycle (4 weeks)
Peak Plasma Concentration (Cmax)
To determine the Peak Plasma Concentration of Bisthianostat.
Time frame: During the first cycle (4 weeks)
Area under the plasma concentration versus time curve (AUC)
To determine the Area under the plasma concentration versus time curve of Bisthianostat.
Time frame: During the first cycle (4 weeks)
Time of Peak Concentration (Tmax)
To determine the time of peak concentration of Bisthianostat.
Time frame: During the first cycle (4 weeks)
Half life (T1/2)
To determine the half-life of Bisthianostat.
Time frame: During the first cycle (4 weeks)
Objective Response Rate
To evaluate the objective response rate in refractory or recurrent myeloma patients after bisthianostat treatments.
Time frame: Up to 1 month after last dose
Incidence of adverse events related to treatments
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To evaluate the incidence of adverse events that are related to treatments in refractory or recurrent myeloma patients
Time frame: Up to 1 month after last dose
Incidence of laboratory abnormalities related to treatments
To evaluate the incidence of laboratory abnormalities that are related to treatments in refractory or recurrent myeloma patients
Time frame: Up to 1 month after last dose