An Exploratory Safety Study to Investigate the Extent of Tumor Cell Mobilization (TCM) After Use of G-CSF Alone or G-CSF Plus Plerixafor in Multiple Myeloma (MM) Patients Who May be Poor Mobilizers of Stem Cells

This is an interventional treatment trial for Multiple Myeloma focused on measuring Hematopoietic stem cell transplantation, Tumour cell mobilization Read More

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Does not have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• 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 mobilization phase.
• Has central nervous system involvement including brain metastases or leptomeningeal disease.
• Has an electrocardiogram (ECG) or study result indicative of cardiac ischemia or a history of clinically significant rhythm disturbance(arrhythmias), or other conduction abnormality.
• 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 protocol.
• 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.