NCT01010880

Brief Summary

BKT-140 drug substance is a highly selective chemokine receptor (CXCR4) antagonist, which is developed by Biokine as a novel therapy for Multiple Myeloma (MM, a type of blood cancer). The unique combination of activities of BKT140, i.e., the induction of the exit of blood cells such as stem cells and mature cells from the bone marrow to the peripheral blood, coupled with specific induction of MM cell death by BKT-140, represents a novel therapeutic strategy against MM.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at P25-P50 for phase_1 multiple-myeloma

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_1 multiple-myeloma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

June 10, 2011

Status Verified

June 1, 2011

Enrollment Period

1.7 years

First QC Date

November 9, 2009

Last Update Submit

June 9, 2011

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaCXCR4Stem CellsMobilizationTransplantationChemotherapy

Outcome Measures

Primary Outcomes (1)

  • White blood cell (WBC) count

    24 hour

Secondary Outcomes (1)

  • CD34+ cells

    24 hour

Interventions

BKT140DRUG

BKT-140 drug substance is a highly selective CXCR4 antagonist. BKT140 will be injected S.C once at dose of 0.03, 0.1, 0.3, 0.9 mg/kg

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females 18 to 65 years old inclusive
  • MM patients with clinically significant disease that achieved at least Partial Response (PR) after induction chemotherapy
  • Patients eligible for HDC with PBSC support.
  • Patients who require stem cell collection with CTX and G-CSF priming.
  • Normal LV functions (EF over 50%, DLCO over 50%)
  • Karnofsky score \> 60%,
  • Patients must have normal renal and liver functions as defined below:
  • Total bilirubin ≤2.0 x institutional upper limit of normal (ULN), unless the patient has a known diagnosis of Gilbert's disease.
  • Aspartate transaminase (AST, SGOT) or alanine transaminase (ALT, SGPT) ≤3 x institutional ULN.
  • Serum creatinine ≤1.5 g/dL or calculated estimated creatinine clearance ≥40 mL/min
  • Polymorphonuclear neutrophil (PMN) count \> 1,500
  • PLT \>100,000
  • Hemoglobin \> 9gr%
  • Women of child-bearing potential must have a negative serum or urine pregnancy test at enrollment.
  • If female, the patient is post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (e.g., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide or abstinence) from the enrollment visit through 30 days after the administration of the study drug.
  • +2 more criteria

You may not qualify if:

  • Patients who have not achieved at least Partial Response (PR) following induction chemotherapy.
  • No pervious G-CSF therapy.
  • Creatinine clearance \<40 mL /min.
  • Body temperature above 385 C on day 10.
  • Patients with blood pressure \<105/60
  • Any of the following in the last 3 months prior to enrollment: Unstable Angina, Acute Myocardial Infarction (MI), Congestive Heart Failure, CVA, uncontrolled blood pressure
  • Pregnant or breast-feeding women.
  • Any medical condition which in the opinion of the Investigator places the patient at an unacceptably high risk for toxicities.
  • Treatment with any investigational agents in the last 21 days before study entry.
  • Any condition or circumstance which, in the opinion of the Investigator, would significantly interfere with the patient's protocol compliance and put the patient at increased risk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Hematology and Bone Marrow Transplantation,Rambam Medical Center

Haifa, 31096, Israel

Location

Chaim Sheba Medical Center,Tel-Hashomer

Ramat Gan, 52621, Israel

Location

Related Publications (1)

  • Abraham M, Biyder K, Begin M, Wald H, Weiss ID, Galun E, Nagler A, Peled A. Enhanced unique pattern of hematopoietic cell mobilization induced by the CXCR4 antagonist 4F-benzoyl-TN14003. Stem Cells. 2007 Sep;25(9):2158-66. doi: 10.1634/stemcells.2007-0161. Epub 2007 May 24.

    PMID: 17525235BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Interventions

BKT140

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Arnon Nagler, MD

    Chaim Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 9, 2009

First Posted

November 10, 2009

Study Start

October 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

June 10, 2011

Record last verified: 2011-06

Locations

IL(2)