Clinical trial · Interventional
CKD-581 + Bortezomib + Dexamethasone in Patients With Previously Treated Multiple Myeloma
A Phase I, Open-Label, Multi-Center Study of CKD-581 in Combination With Bortezomib and Dexamethasone in Patients With Previously Treated Multiple Myeloma
NCT03051841CI-TRIAL-00043583unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloma, Multiple | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CKD-581 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treat Regimen
- description
- CKD-581(investigational Drug) Bortezomib Dexamethasone
- interventionNames
- Drug: CKD-581
Primary outcomes (1)
- measure
- Maximum Tolerated Dose(MTD)
- timeFrame
- Up to 21 days(for 1st cycle)
Secondary outcomes (12)
- measure
- Pharmacokinetics(Cmax)
- timeFrame
- 1st Cycle day1, Day8: up to 24hr
- measure
- Number of participants with toxicity as assessed by CTCAE v4.03 through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.