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

NCT03150316 | Unknown Phase 1

• 1 other identifier: 133MM16016
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief 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 Myeloma.

Conditions

Myeloma, Multiple

Outcome Measures

Primary Outcomes (1)

• MTD

  Maximum Tolerated Dose

  Up to 28 days(for 1st cycle)

Secondary Outcomes (1)

• Pharmacokinetics(Cmax)

  1st Cycle day1: up to 24hr

Other Outcomes (11)

• Objective Response Rate(ORR)

  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

• Progression Free Survival(PFS)

  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)

  Average time period between the start day of induction therapy and the day of death, due to any cause, up to 1year

Study Arms (1)

Treat Regimen

EXPERIMENTAL

CKD-581(investigational Drug) Lenalidomide Dexamethasone

Drug: Treat Regimen

Interventions

Treat Regimen DRUG

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

Also known as: CKD-581 lenalidomide dexamethasone regimen

Treat Regimen

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (2)

Samsung Hospital

Seoul, Gangnam-gu, 06351, South Korea

RECRUITING

the catholic university of korea, Seoul ST. Mary's Hospital

Seoul, Seocho, 06591, South Korea

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Chanki Min

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minji Song

CONTACT

02-3149-7853; songmj@ckdpharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 12, 2017
• Study Start: May 10, 2017
• Primary Completion: June 30, 2020
• Study Completion: September 30, 2021
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)