A Phase I Study of the Safety and Feasibility of Bortezomib in Combination With G-CSF for Stem Cell Mobilization in Patients With Multiple Myeloma
The purpose of this research study is to determine the highest dose of a drug called bortezomib that can be given with a drug called G-CSF before stem cell collection to help in the mobilization of stem cells.
• Histologically confirmed diagnosis of multiple myeloma.
• Eligible for autologous transplantation.
• Received at least two cycles of any regimen as initial systemic therapy for multiple myeloma and are within 2-12 months of the first dose of initial therapy.
• At least 18 years of age.
• ECOG performance status ≤ 2
• Normal bone marrow and organ function as defined below:
‣ Platelets ≥ 50,000/mm3
⁃ Hemoglobin ≥ 8.0 g/dL
⁃ Absolute neutrophil count ≥1,000/mm3
⁃ AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
⁃ Total bilirubin ≤ 1.5 x IULN
⁃ Measured or calculated creatinine clearance ≥ 30 mL/min
• Female patients who:
‣ are postmenopausal for at least 1 year before the screening visit OR
⁃ are surgically sterile OR
⁃ Women of childbearing potential and men must agree to practice 2 effective methods of contraception prior to study entry, for the duration of study participation, and for 30 days after the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
• Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).