This phase II clinical trial studies two doses of cyclophosphamide in mobilizing stem cells in patients with non-Hodgkin’s lymphoma or multiple myeloma undergoing transplant. Certain chemotherapy drugs, such as cyclophosphamide, help stem cells move from the bone marrow to the blood so they can be collected and stored. It is not yet known whether a lower dose of cyclophosphamide is a better treatment than a higher dose to mobilize bone marrow cells into the blood for collection.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02139280.
PRIMARY OBJECTIVES:
I. To determine if a lower dose of cyclophosphamide combined with filgrastim can mobilize an adequate number of cluster of differentiation (CD)34+ progenitor cells with less toxicity.
SECONDARY OBJECTIVES:
I. Define resource utilization during the mobilization and apheresis processes: transfusions of red blood cells, transfusion of platelets, hospitalizations, incidence of febrile neutropenia.
TERTIARY OBJECTIVES:
I. Determine the post-transplant engraftment of neutrophils and platelets.
II. Qualitative and quantitative analyses of mobilized lymphocytes (Elective-pending funding).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive low-dose cyclophosphamide intravenously (IV) over 1 hour according to Dartmouth Hitchcock Medical Center (DHMC) standard operating procedures (SOP). Approximately 48 hours after cyclophosphamide, patients also receive filgrastim subcutaneously (SC) daily until completion of leukapheresis.
ARM II: Patients receive high-dose cyclophosphamide IV over 1 hour according to DHMC SOP. Approximately 48 hours after cyclophosphamide, patients also receive filgrastim SC daily until completion of leukapheresis.
Patients in both arms undergo leukapheresis 10-12 days following cyclophosphamide.
Lead OrganizationDartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Principal InvestigatorKenneth R. Meehan