Phase II to Treat Multiple Myeloma Patients With Cytoxan and Vincristine After Cycling Myeloma Cells With rHuGM-CSF
OBJECTIVES: I. Determine the response rate of multiple myeloma patients when treated with
cyclophosphamide and vincristine after cycling myeloma cells with sargramostim (GM-CSF). II.
Evaluate whether Labelling Index (LI) changes influenced by GM-CSF would predict a group of
patients that will respond to this particular course specific design. III. Determine the
toxicity of GM-CSF in these patients.
OUTLINE: Patients receive subcutaneous injections of sargramostim (GM-CSF) once a day for 5
days. Two to 3 days later, patients receive cyclophosphamide IV over 30-45 minutes on day 1,
vincristine IV bolus on day 8, and oral prednisone 4 times a day on days 1-4. Patients also
receive subcutaneous injections of GM-CSF starting on day 2 and continuing for 10 days or
until neutrophil count is at least 1000/mm3. Treatment continues every 3 weeks for a minimum
of 6 courses in the absence of disease progression or unacceptable toxicity. Patients who
achieve at least stable response receive GM-CSF 3 times a week for up to 2 years. Patients
are followed every 3-6 months.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued.
Primary Purpose: Treatment
Mohamad A. Hussein, MD
The Cleveland Clinic
United States: Federal Government
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