A Pilot, Exploratory, Randomized, Phase 2 Safety Study Evaluating Tumor Cell (Plasma Cell) Mobilization and Apheresis Product Contamination in Plerixafor Plus Non-pegylated G-CSF Mobilized Patients and in Non-pegylated G-CSF Alone Mobilized Patients
- Patients with a diagnosis of MM in partial response or complete response, who are
undergo an autologous hematopoietic stem cell transplantation and could be considered
potentially poor mobilizers.
- Does not have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- Has a history of any acute or chronic leukemia (including myelodysplastic syndrome).
- Had prior allogeneic or autologous transplantation.
- Less than 3 to 6 weeks since last anti-cancer therapy.
- Chemotherapy for mobilization is not allowed.
- Has bone marrow involvement >10% assessed based on the most recent bone marrow
aspirate or biopsy performed prior to first dose of G-CSF.
- Was treated with G-CSF or other cytokine within 14 days prior to the first dose of
G-CSF for mobilization.
- Has previously received plerixafor.
- Is known to be HIV positive.
- Has active hepatitis B or hepatitis C.
- Has an acute infection within 24 hours prior to dosing or antibiotic therapy within 7
days prior to the first dose of G-CSF.
- Has hypercalcaemia as evidenced by >1 mg/dL above upper limit of normal (ULN).
- Previously received investigational therapy within 4 weeks of screening in this
protocol or currently enrolled in another investigational protocol during the
- Has central nervous system involvement including brain metastases or leptomeningeal
- Has an electrocardiogram (ECG) or study result indicative of cardiac ischemia or a
history of clinically significant rhythm disturbance(arrhythmias), or other
- Has co-morbid condition(s), which may render the patient at high risk from treatment
complications or impairs his/her ability to comply with the study treatment and
- Has a white blood cell (WBC) count <2.5 x 10^9/L.
- Has an absolute neutrophil count (ANC) <1.5 x 10^9/L.
- Has a platelet count <100 x 10^9/L.
- Has an estimated creatine clearance ≤50 mL/min.
- Has aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT),
alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT), and total
bilirubin ≥2.5 x ULN.
- Does not have adequate cardiac, and pulmonary function sufficient to undergo
apheresis and transplantation.
- Pregnant or breastfeeding women.
- Does not agree to use a highly effective method of contraception while on study
treatment and for at least 3 months following study treatment.