Safety Study of a Chemokine Receptor (CXCR4) Antagonist in Multiple Myeloma Patients

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biokine Therapeutics Ltd

Criteria

Inclusion Criteria:

• 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.

• If male, the patient agrees to use an acceptable barrier method of contraception from the time of enrollment through 30 days after the administration of the study drug.

• Prior to enrollment, the patient is capable of understanding the protocol and able to sign a written informed consent.

Exclusion Criteria:

• 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.