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

Conditions: Multiple Myeloma

Summary: the primary objective of this study is to evaluate tumor cell mobilization (tcm) with non-pegylated g-csf alone compared with non-pegylated g-csf plus plerixafor in patients with multiple myeloma (mm) who are potentially poor mobilizers of hematopoietic stem cells (hsc). second objectives are to evaluate survival and disease status of g-csf alone compared with gcsf plus plerixafor, and the efficacy and safety of g-csf plus plerixafor when used to mobilize stem cells for autologous transplantation.


Eligibility criteria:
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.

Keywords: hematopoietic stem cell transplantation tumour cell mobilization