Status and phase
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About
This study is to determine the maximum tolerated dose(MTD), dose limiting toxicity(DLT), safety and pharmacokinetics(PK) profile of a single agent CKD-581 injection in Combination with Bortezomib and Dexamethasone in patients with Previously Treated Multiple Myeloma.
Full description
This is an open label, dose escalation study. Cohort of 3~6 patients receive escalation doses of CKD-581 until the maximum toleated dose(MTD) is determined. The MTD is defiend as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.
Enrollment
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Volunteers
Inclusion criteria
must have received at least one prior lines of therapy and Diagnosis of symptomatic multiple myeloma(IMWG 2014)
Eastern Cooperative Oncology Group performance status ≤ 2
Life expectancy 12 weeks
must have the following laboratory values within 3 weeks prior to first dose of study drug
One more measureable disease following values
more than 24 weeks prior to last bortezomib dose
must have signed the consent form
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
18 participants in 1 patient group
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Central trial contact
Min Ji Song
Data sourced from clinicaltrials.gov
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