This randomized phase II trial studies collecting stem cell with or without bortezomib treatment in patients with multiple myeloma undergoing autologous stem cell transplant. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth which may cause cancer cells to die. Autologous stem cell transplant is a standard procedure in which bone marrow stem cells are removed from the patient's blood, treated in the laboratory, and stored while the patient is treated with chemotherapy and/or radiotherapy to kill any remaining cancer cells that are in the body. After intensive treatment, the stem cells are then given back to the patient to replace the blood-forming cells that were destroyed by chemotherapy and/or radiation therapy. Some of the cancer cells however remain in the stem cells that are given back to the patient which may lead to poor disease free survival. Doctors want to know whether giving bortezomib before stem cell collection may decrease the number of cancer cells remaining in the sample of collected stem cells. It is not yet known whether giving bortezomib before stem cell collection is more effective than standard stem cell collection without bortezomib in decreasing the number of stem cells contaminated with cancer cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02703779.
PRIMARY OBJECTIVES:
I. To estimate the proportion of subjects with plasma cell contamination (defined as > 0.01% and at least 100 cellular events) (Rawstron AC et al, 2008 and Shah, Callander and Ganguly et al, 2015) of harvested stem cell product by multi parametric flow cytometry from patients with myeloma undergoing autologous stem cell collection by standard of care mobilization using granulocyte colony-stimulating factor (GCSF) (filgrastim) with or without Mozobil (plerixafor).
II. To estimate the proportion of subjects with plasma cell contamination (defined as > 0.01% and at least 100 cellular events) (Rawstron AC et al, 2008 and Shah, Callander and Ganguly et al, 2015) of harvested stem cell product by multi parametric flow cytometry from patients with myeloma undergoing autologous stem cell collection after two doses of bortezomib as in vivo purging plus standard of care using GCSF with or without Mozobil.
SECONDARY OBJECTIVES:
I. To estimate the proportion of subjects who have a successful collection of stem cells (> 2 million cluster of differentiation [CD]34 cells/Kg of body weight) for autologous transplant in both treatment groups.
II. To estimate the percentage of CD34 positive cells in peripheral blood on the days of collection.
OUTLINE: Patients are randomized to 1 of 2 treatment groups.
GROUP A: Patients receive filgrastim with or without plerixafor and undergo standard of care autologous stem cell mobilization.
GROUP B: Patients receive bortezomib subcutaneously (SC) on days -11 and - 8 and filgrastim SC on day -4 to -1. Patients then undergo autologous stem cell mobilization on day 0.
After completion of study, patients are followed up for 30 days.
Lead OrganizationUniversity of Kansas Cancer Center
Principal InvestigatorSiddhartha Ganguly
