Myeloma, MultiplePhase 1NCT03051841
CKD-581 + Bortezomib + Dexamethasone in Patients With Previously Treated Multiple Myeloma
A Phase 1 study testing CKD-581 in people with Myeloma, Multiple, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Myeloma, Multiple
- What is being tested?
- CKD-581
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2017to Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Sung-Soo Yoon, +82-2-2072-3079, ssysmc@gmail.com
About this study
Official title: A Phase I, Open-Label, Multi-Center Study of CKD-581 in Combination With Bortezomib and Dexamethasone in Patients With Previously Treated Multiple Myeloma
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.
Read the detailed 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.
- Conditions
- Myeloma, Multiple
- Being tested
- CKD-581
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-581Drug
Also called CKD-581 bortezomib dexamethasone regimen
Intravenously on Days 1, 8 of each 21-day treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Treat Regimen | Experimental | CKD-581(investigational Drug) Bortezomib Dexamethasone Receives: Drug: CKD-581 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose(MTD)
Measured: Up to 21 days(for 1st cycle)
Secondary outcomes (12)
Pharmacokinetics(Cmax)
Measured: 1st Cycle day1, Day8: up to 24hr
Number of participants with toxicity as assessed by CTCAE v4.03 through study completion, an average of 1 year
Measured: through study completion, an average of 1 year
Objective Response Rate(ORR) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks
Measured: every 6weeks, up to 1year
Progression Free Survival(PFS) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks
Measured: Average time period between the start day of induction therapy and the day of relapse or progression or death, whichever occurs firstly, up to 1year
Overall Survival(OS) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks
Measured: Average time period between the start day of induction therapy and the day of death, due to any cause, up to 1year
Duration of Response(DOR) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks
Measured: Average time period between the day of first achievement of response and the day of first relapse or progression, up to 1year
Pharmacokinetics(T1/2)
Measured: 1st Cycle day1, Day8: up to 24hr
Pharmacokinetics(CL)
Measured: 1st Cycle day1, Day8: up to 24hr
Pharmacokinetics(AUClast)
Measured: 1st Cycle day1, Day8: up to 24hr
Pharmacokinetics(AUCinf)
Measured: 1st Cycle day1, Day8: up to 24hr
Pharmacokinetics(Vd)
Measured: 1st Cycle day1, Day8: up to 24hr
Pharmacokinetics( MRT)
Measured: 1st Cycle day1, Day8: up to 24hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study startJan 2017
- Primary completionApr 2021 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloma, MultipleStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Ji Song, Study director, Chong Kun Dang Pharmaceutical Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051841
- Sponsor's protocol ID
- 133MM16010
- Status last verified
- Feb 2020
- First submitted
- 9 Jan 2017
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Multi-Center Study of CKD-581 in Combination With Bortezomib and Dexamethasone in Patients With Previously Treated Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03051841
- Acronym / sponsor ID
- 133MM16010
- Conditions
- Myeloma, Multiple
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jan 2017
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 14 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treat Regimen | Experimental | Drug: CKD-581CKD-581(investigational Drug) Bortezomib Dexamethasone |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CKD-581Also: CKD-581 bortezomib dexamethasone regimenIntravenously on Days 1, 8 of each 21-day treatment cycle. | Drug | Treat Regimen |
Primary outcome
Maximum Tolerated Dose(MTD)
Time frame: Up to 21 days(for 1st cycle)
12 secondary outcomes
Pharmacokinetics(Cmax)
Time frame: 1st Cycle day1, Day8: up to 24hr
Number of participants with toxicity as assessed by CTCAE v4.03 through study completion, an average of 1 year
Time frame: through study completion, an average of 1 year
Objective Response Rate(ORR) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks
Time frame: every 6weeks, up to 1year
Progression Free Survival(PFS) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks
Time frame: Average time period between the start day of induction therapy and the day of relapse or progression or death, whichever occurs firstly, up to 1year
Overall Survival(OS) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks
Time frame: Average time period between the start day of induction therapy and the day of death, due to any cause, up to 1year
Duration of Response(DOR) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks
Time frame: Average time period between the day of first achievement of response and the day of first relapse or progression, up to 1year
Pharmacokinetics(T1/2)
Time frame: 1st Cycle day1, Day8: up to 24hr
Pharmacokinetics(CL)
Time frame: 1st Cycle day1, Day8: up to 24hr
Pharmacokinetics(AUClast)
Time frame: 1st Cycle day1, Day8: up to 24hr
Pharmacokinetics(AUCinf)
Time frame: 1st Cycle day1, Day8: up to 24hr
Pharmacokinetics(Vd)
Time frame: 1st Cycle day1, Day8: up to 24hr
Pharmacokinetics( MRT)
Time frame: 1st Cycle day1, Day8: up to 24hr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Ji Song study director
Chong Kun Dang Pharmaceutical Corp.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CKD-581 in people with Myeloma, Multiple, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Ji Song (+82-2-3149-7853, songmj@ckdpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose(MTD) (time frame: Up to 21 days(for 1st cycle)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.