Based on the pre-clinical data the investigators hypothesize that G-CSF treatment in patients with multiple myeloma will generate a 'hostile' bone marrow microenvironment for myeloma cells, depriving them of key support signals and rendering them more sensitive to chemotherapy. The investigators therefore propose to do an initial pilot study 1) to explore the safety of the combination of G-CSF and bortezomib-, carfilzomib-, or IMID-based treatment regimens in patients with bortezomib-, carfilzomib-, or IMID-refractory myeloma and 2) to generate correlative data for a subsequent larger study looking at the combination.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Washington University School of Medicine
St Louis, Missouri, United States
Safety of the combination of G-CSF and bortezomib-, carfilzomib-, or IMID-based treatment regimens in patients with refractory multiple myeloma.
Number and grade of adverse events based on NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time frame: Up to 30 days after last treatment
Effects of G-CSF on bone marrow and bone marrow cytokine and chemokine levels. Including: Quantification of marrow osteoblasts and CAR cells, measurement of SDF-1 (CXCL12), IL-6, BAFF, assessment of myeloma cell proliferation and survival in bone marrow
Time frame: 14 days after last drug treatment
Response rate as defined by the International Myeloma Working Group (IMWG) criteria
Time frame: 14 days after last drug treatment
Overall survival duration of patients treated on study
Defined as the date of first dose of study drug to the date of death from any cause.
Time frame: 1 year
Progression-free survival of patients treated on study
Defined as the interval from the date of first treatment to date of first documentation of disease progression.
Time frame: 1 year
Duration of response of patients treated on study
Defined as the interval from the date of first documentation of response to the first documentation of disease progression.
Time frame: 1 year
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