CKD-581 + Bortezomib + Dexamethasone in Patients With Previously Treated Multiple Myeloma

  • End date
    Nov 24, 2022
  • participants needed
  • sponsor
    Chong Kun Dang Pharmaceutical
Updated on 28 January 2022
platelet count
neutrophil count


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.


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.

Condition Myeloma, Multiple
Treatment CKD-581
Clinical Study IdentifierNCT03051841
SponsorChong Kun Dang Pharmaceutical
Last Modified on28 January 2022


Yes No Not Sure

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
ANC(absolute neutrophil count) 1,500 mm3
PLT(platelet count) 100,000 mm3
Hb 8.0g/dL
AST(SGOT) and ALT (SGPT) 3 x UNL(upper limit of normal)
Serum bilirubin 1.5 x ULN (but, Gilbert syndrome 3 x UNL)
Serum Cr 1.5 x UNL
One more measureable disease following values
Serum M-protein 1g/dL
Urine M-Protein 200mg/24hr
in that case serum M-protein, urine M-Protein nonmeasurable and FLC ratio abnormal, Serum FLC level 100mg/L(10mg/dL)
more than 24 weeks prior to last bortezomib dose
must have signed the consent form

Exclusion Criteria

Patients with central neurological disease
Patients with clinically significant heart disease within 24weeks prior to first dose of study drug
patients with clinically significans abnormal EKG, echocardiography at screening
patients with active hepatitis, HIV positive(exception, non active hepatitis)
peripheral neuropathy CTCAE grade 2 or peripheral neuropathy CTCAE grade 1 with pain within 2 weeks prior to first dose of study drug
Patients with a prior malignancy with in the last 3 years except adequately treated basal cell or squamous cell or skin cancer, in situ cervical cancer
Patients who have received surgery, chemotherapy, radiation therapy or immunotherapy or any other investigational drugs 4 weeks prior to first dose of study drug and during treatment period
Women who are pregnant or breast feeding or women of childbearing potential not using an effective method of birth control. Male patients whose sexual partners are not using effective birth control
patients with hypersensitive reaction of bortezomib or dexamethasone
patients without best overall response is above minimal response based on IMWG 2015 past all treatment for multiple myeloma
patients with refractory to past bortezomib treatment(ex; under minimal response) or progress within 60days prior to last bortezomib treatment
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