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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01010880
• Date of registration: 09/11/2009
• Primary sponsor: Biokine Therapeutics Ltd
• Public title: Safety Study of a Chemokine Receptor (CXCR4) Antagonist in Multiple Myeloma Patients
• Scientific title: A Phase I/IIA, Non-Randomized, Open Label, Single Dose, Dose-Escalation, Safety Study of BKT140, a CXCR4 Antagonist in Patients With Multiple Myeloma
• Date of first enrolment: October 2008
• Target sample size: 16
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01010880
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Israel

Contacts

• Name: Arnon Nagler, MD
• Affiliation: Chaim Sheba Medical Center

Key inclusion & exclusion 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.



Age minimum: 16 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Myeloma

Intervention(s)

Drug: BKT140

Primary Outcome(s)

White blood cell (WBC) count [Time Frame: 24 hour]

Secondary Outcome(s)

CD34+ cells [Time Frame: 24 hour]

Secondary ID(s)

BKTSC001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors