This randomized phase II trial studies how well filgrastim with or without meloxicam works in mobilizing stem cells in patients with lymphoma or multiple myeloma eligible for stem cell transplant. Filgrastim and meloxicam may help stem cells to increase in number and move from the patient's bone marrow to the blood making their collection process easier.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02003625.
PRIMARY OBJECTIVES:
I. Determine if meloxicam in conjunction with filgrastim (G-CSF) leads to increased numbers of circulating cluster of differentiation (CD)34+ cells on the first day of apheresis compared to G-CSF + placebo.
II. Determine how many apheresis sessions are required to collect >= 4 x 10^6 CD34+ cells/kg for multiple myeloma patients and >= 2 x 10^6 CD34+ cells/kg for lymphoma patients in the G-CSF + meloxicam group compared to the G-CSF group.
SECONDARY OBJECTIVES:
I. To determine that meloxicam is safe when used in combination with G-CSF for stem cell mobilization.
II. The time to neutrophil and platelet engraftment after autologous hematopoietic stem cell transplant (AHSCT).
III. To evaluate transfusion support (number of red blood cells and platelet transfusions needed prior to red blood cell and platelet engraftment).
IV. Proportion of patients failing stem cell mobilization.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive filgrastim subcutaneously (SC) daily beginning on day -4. Treatment continues for a total of 4 apheresis sessions or until >= 4 x 10^6 CD34+ cells/kg for multiple myeloma patients or > 2 x 10^6 CD34+ cells/kg for lymphoma patients are collected. Patients also receive placebo orally (PO) daily on days -6 to -2. Multiple myeloma patients may optionally receive cyclophosphamide intravenously (IV) on day -12.
ARM B: Patients receive filgrastim as in Arm A and meloxicam PO daily on days -6 to -2. Multiple myeloma patients may optionally receive cyclophosphamide IV on day -12.
After completion of study treatment, patients are followed up for 6 months.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorBimalangshu Ranjan Dey