Myeloma, MultiplePhase 1NCT03150316
CKD-581 + Lenalidomide + Dexamethasone in Patients With Previously Treated Multiple Myeloma
A Phase 1 study testing Treat Regimen in people with Myeloma, Multiple, run by Chong Kun Dang Pharmaceutical at 2 sites in South Korea.
Trial summary
This study is to determine the maximum tolerated dose(MTD) and recommened phase 2 dose(RP2D) based on dose limiting toxicity(DLT), and to evaluate safety and pharmacokinetics(PK) profile of a single agent CKD-581 injection in Combination with Lenalidomide and Dexamethasone in patients with Previously Treated Multiple… 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?
- Treat Regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 10 May 2017to 30 Sep 2021
- 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 two prior lines of therapy and Diagnosis of symptomatic multiple myeloma(IMWG 2015)
- 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
- absolute neutrophil count(ANC) ≥ 1,500 mm3
- platelet count(PLT)≥ 100,000 mm3
Show all 16Show fewer
- Hb ≥ 9.0g/dL
- AST(SGOT) and ALT(SGPT) ≤ 3 x upper limit of normal(UNL)
- Serum bilirubin ≤ 1.5 x ULN (but, Gilbert syndrome ≤ 3 x UNL)
- Creatinin Clearance(CrCl) ≤ 50mL/min
- 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 free light chain(FLC) level ≥ 100mg/L(≥10mg/dL)
- more than 24 weeks prior to last lenalidomide dose
- must have signed the consent form
Who cannot join
- Patients with CNS 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 patients with embolism within 24 weeks
- patients with active hepatitis, HIV positive(exception, non active hepatitis)
- peripheral neuropathy ≥ CTCAE grade 2 within 2 weeks prior to first dose of study drug
Show all 13Show fewer
- Patients with clinically significant disease
- 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
- Patients who can not anticoagulate
- Patients who have received dexamethasone >10mg/day within 2week 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 lenalidomide or dexamethasone
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Samsung Hospital
Seoul, Gangnam-gu, 06351
Ki Hyun Kim, PI
- Recruiting
the catholic university of korea, Seoul ST. Mary's Hospital
Seoul, Seocho, 06591
Chang-ki Min, PI
About this study
Official title: A Phase I, Open-Label, Multi-Center Study of CKD-581 in Combination With Lenalidomide and Dexamethasone in Patients With Previously Treated Multiple Myeloma
This study is to determine the maximum tolerated dose(MTD) and recommened phase 2 dose(RP2D) based on dose limiting toxicity(DLT), and to evaluate safety and pharmacokinetics(PK) profile of a single agent CKD-581 injection in Combination with Lenalidomide 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-516 until the maximum tolerated dose(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.
- Conditions
- Myeloma, Multiple
- Being tested
- Treat Regimen
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treat RegimenDrug
Also called CKD-581 lenalidomide dexamethasone regimen
CKD-581(investigational Drug): on days 1, 8, 15 of repeated 28day cycles Lenalidomide: on days 1~21 of repeated 28 day cycles Dexamethasone: administrated once weekly every 28day cycles
| Study group | Role | What they receive |
|---|---|---|
| Treat Regimen | Experimental | CKD-581(investigational Drug) Lenalidomide Dexamethasone Receives: Drug: Treat Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
Maximum Tolerated Dose
Measured: Up to 28 days(for 1st cycle)
Secondary outcomes (1)
Pharmacokinetics(Cmax)
Pharmacokinetics
Measured: 1st Cycle day1: 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 posted12 May 2017
- Study start10 May 2017
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Sep 2021 (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.
- 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
- Chanki Min, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150316
- Sponsor's protocol ID
- 133MM16016
- Status last verified
- Feb 2020
- First submitted
- 10 May 2017
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Lenalidomide and Dexamethasone in Patients With Previously Treated Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03150316
- Acronym / sponsor ID
- 133MM16016
- 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
- 10 May 2017 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 12 May 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) and recommened phase 2 dose(RP2D) based on dose limiting toxicity(DLT), and to evaluate safety and pharmacokinetics(PK) profile of a single agent CKD-581 injection in Combination with Lenalidomide 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-516 until the maximum tolerated dose(MTD) is determined. The MTD is defined 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: Treat RegimenCKD-581(investigational Drug) Lenalidomide 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 two prior lines of therapy and Diagnosis of symptomatic multiple myeloma(IMWG 2015)
- 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 (13 listed)
- Patients with CNS 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 patients with embolism within 24 weeks
- patients with active hepatitis, HIV positive(exception, non active hepatitis)
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 |
|---|---|---|
| Treat RegimenAlso: CKD-581 lenalidomide dexamethasone regimenCKD-581(investigational Drug): on days 1, 8, 15 of repeated 28day cycles Lenalidomide: on days 1~21 of repeated 28 day cycles Dexamethasone: administrated once weekly every 28day cycles | Drug | Treat Regimen |
Primary outcome
MTD
Time frame: Up to 28 days(for 1st cycle)
Maximum Tolerated Dose
1 secondary outcome
Pharmacokinetics(Cmax)
Time frame: 1st Cycle day1: 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: No
Related trials for Myeloma, Multiple
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
RecruitingPhase 1/2
AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma
Multiple Myeloma
RecruitingPhase 1
Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Relapsed Multiple Myeloma, Refractory Multiple Myeloma
RecruitingPhase 1
A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
Multiple Myeloma (MM)
Active, not recruiting
Real World Treatment Experience of Patients With Breast, Lung, or GI Cancer or Multiple Myeloma Using Remote Symptom Monitoring
Breast Cancer, Lung Cancer
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.
Chanki Min principal investigator
The Catholic University of Korea
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treat Regimen in people with Myeloma, Multiple, run by Chong Kun Dang Pharmaceutical at 2 sites 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 13 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 2 sites 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 Minji Song (02-3149-7853, songmj@ckdpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (time frame: Up to 28 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.