Mozobil is a hematopoietic stem cell mobilizer and inhibitor of the CXCR4 chemokine receptor. CXXR4 is specific for stromal-derived-factor-1 (SDF-1), a molecule endowed with potent chemotactic activity for lymphocytes. Because the interaction between SDF-1 and CXCR4 plays an important role in holding hematopoietic stem cells in the bone marrow, drugs that block the CXCR4 receptor appear to be capable of ""mobilizing"" hematopoietic stem cells into the bloodstream.
Mozobil, in combination with granulocyte-colony stimulating factor (G-CSF), is specifically indicated to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM).
Mozobil is supplied as a solution designed for subcutaneous injection. Treatment with Mozobil should begin after the patient has received G-CSF once daily for four days. Mozobil should be administered approximately 11 hours prior to initiation of apheresis for up to 4 consecutive days. The recommended initial dose of the drug is 0.24 mg/kg body weight by subcutaneous (SC) injection. The dose should not exceed 40 mg/day. In patients with moderate and severe renal impairment (estimated creatinine clearance (CLCR) = 50 mL/min), the dose of Mozobil should be reduced by one-third, to 0.16 mg/kg.
This study enrolled 298 subjects with non-Hodgkin's lymphoma. Data showed that 59% of the subjects with NHL who were mobilized with Mozobil and G-CSF collected ≥ 5 X 106 CD34+ cells/kg from the peripheral blood in four or fewer apheresis sessions, compared with 20% of patients who were mobilized with placebo and G-CSF (p < 0.001). The median number of days to reach ≥ 5 x 106 CD34+ cells/kg was 3 days for the Mozobil group and not evaluable for the placebo group.
This trial enrolled 302 subjects with multiple myeloma. Data showed that 72% of MM patients who were mobilized with Mozobil and G-CSF collected ≥ 6 X 106 CD34+ cells/kg from the peripheral blood in two or fewer apheresis sessions, compared with 34% of patients who were mobilized with placebo and G-CSF (p < 0.001). The median number of days to reach ≥ 6 x 106 CD34+ cells/kg was 1 day for the Mozobil group and 4 days for the placebo group.
Ongoing Study Commitments
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