This phase II trial studies how well meloxicam and filgrastim work in collecting peripheral blood stem cells for transplant in patients with multiple myeloma, Hodgkin lymphoma, or non-Hodgkin lymphoma. Colony-stimulating factors, such as filgrastim, help stem cells move from the patient’ s bone marrow to the blood so they can be collected and stored. Meloxicam is a non-steroidal anti-inflammatory drug that may act together with filgrastim to increase the number of cells collected for transplant.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02078102.
PRIMARY OBJECTIVES:
I. To investigate whether meloxicam and filgrastim can result in a 20% increase in the proportion of patients who mobilize and collect at least half of the total target cluster of differentiation (CD)34+ cell dose in the first apheresis.
SECONDARY OBJECTIVES:
I. Describe the toxicity profile of the combination of meloxicam and filgrastim.
II. Describe the graft composition of peripheral blood stem cells (PBSC) collected using meloxicam and filgrastim including, hematopoietic and immune cell subsets.
III. Describe the engraftment kinetics of meloxicam and filgrastim mobilized PBSC in multiple myeloma (MM), Hodgkin lymphoma (Hodgkin disease [HD]) and non-Hodgkin lymphoma (NHL) patients undergoing myeloablative autologous PBSC transplantation.
OUTLINE:
MOBILIZATION: Patients receive meloxicam orally (PO) once daily (QD) on days 1-5 and filgrastim subcutaneously (SC) on days 4-7.
APHERESIS: Patients undergo apheresis on day 1 and receive filgrastim SC on day 1. Patients who did not collect at least half of the total CD34+ cell dose in the first apheresis may undergo additional apheresis on days 2-4, receive filgrastim on days 2-4, and receive plerixafor as determined by the treatment physician.
TRANSPLANT: Patients who mobilize sufficient numbers of CD34+ cells may undergo autologous PBSC transplant on day 0 per institutional standards.
After completion of study treatment, patients are followed up to day 100.
Lead OrganizationIndiana University/Melvin and Bren Simon Cancer Center
Principal InvestigatorSherif Shafik Farag