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

  • STATUS
    Recruiting
  • End date
    Nov 24, 2022
  • participants needed
    18
  • sponsor
    Chong Kun Dang Pharmaceutical
Updated on 28 January 2022
platelet count
dexamethasone
neutrophil count
bortezomib

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.

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.

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

Eligibility

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note