Clinical Trial: Bortezomib and Filgrastim in Promoting Stem Cell Mobilization in Patients With Non-Hodgkin Lymphoma or Multiple Myeloma Undergoing Stem Cell Transplant

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Pilot Study of Peripheral Blood Hematopoietic Stem Cell Mobilization With the Combination of Bortezomib and G-CSF in Multiple Myeloma and Non-Hodgkin's Lymphoma Patients

Brief Summary: This clinical trial studies peripheral blood hemapoietic stem cell mobilization with the combination of bortezomib and G-CSF (filgrastim) in multiple myeloma and non-Hodgkin lymphoma patients. Giving chemotherapy before a peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine if addition of Bortezomib to the mobilization protocol will result with an increase in the levels of circulating peripheral blood stem cells (PBSCs) by >= 2-fold in blood and in the apheresis collections in up to 4-days collection protocol.

II. To achieve median neutrophil engraftment of 12 days.

SECONDARY OBJECTIVES:

I. To test for co-mobilization of lymphoma or myeloma cells by bortezomib and G-CSF using real time polymerase chain reaction (PCR) for non-Hodgkin lymphoma (NHL) patients and by flow cytometry (cluster of differentiation [CD]38+/CD138+ cell) for multiple myeloma (MM) patients.

II. To determine the effect of Bortezomib on the extent of mobilization of dendritic cells subsets, plasmacytoid dendritic cell (pDC)1 and pDC2 and DC1/DC2 ratio by flow cytometry.

OUTLINE: Patients are assigned to 1 of 2 treatment groups.

GROUP A: Patients receive filgrastim subcutaneously (SC) on days 1-9 and begin apheresis on day 5. Patients undergo apheresis for up to 2 days, and receive bortezomib intravenously (IV) over 3-5 seconds after target collection is obtained with filgrastim alone or on the first day of collection with the Bortezomib plus filgrastim mobilization, prior to receiving the administration of filgrastim. Second apheresis will continue until target stem cell dose is reached or for maximum 4 days. Patients undergo autologous hematopoietic stem cell transplantation after receiving high dose chemotherapy and peripheral blood stem cell (PBSC) infusion following standard of care procedures.

  • Increase in levels of circulating PBSC by at least two-fold in the blood and in the apheresis collections in a 4-day collection protocol [ Time Frame: Up to 6 months ]
    All analyses will be descriptive and exploratory. The shape of the frequency distributions of each of the endpoints will be examined graphically and analytically to determine the appropriate statistical analyses. Paired comparisons will be made using t-tests and box plots will be used to describe each of the endpoints. Estimates will be made with 95% confidence limits.
  • Neutrophil engraftment [ Time Frame: Up to 6 months ]
    All analyses will be descriptive and exploratory. The shape of the frequency distributions of each of the endpoints will be examined graphically and analytically to determine the appropriate statistical analyses. Paired comparisons will be made using t-tests and box plots will be used to describe each of the endpoints. Estimates will be made with 95% confidence limits.


    • Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Co-mobilization of lymphoma or myeloma cells by bortezomib and filgrastim [ Time Frame: Up to 6 months ]
      All analyses will be descriptive and exploratory. The shape of the frequency distributions of each of the endpoints will be examined graphically and analytically to determine the appropriate statistical analyses. Paired comparisons will be made using t-tests and box plots will be used to describe each of the endpoints. Estimates will be made with 95% confidence limits.
    • Mobilization of dendritic cell subsets pDCI and pDC2 and the ratio DC1/DC2 [ Time Frame: Up to 6 months ]
      All analyses will be descriptive and exploratory. The shape of the frequency distributions of each of the endpoints will be examined graphically and analytically to determine the appropriate statistical analyses. Paired comparisons will be made using t-tests and box plots will be used to describe each of the endpoints. Estimates will be made with 95% confidence limits.


    Original Secondary Outcome: Same as current

    Information By: Barbara Ann Karmanos Cancer Institute

    Dates:
    Date Received: January 14, 2014
    Date Started: July 2011
    Date Completion: June 2017
    Last Updated: April 19, 2016
    Last Verified: April 2016