Phase II Study to Evaluate Fenofibrate Therapy in Patients With Smoldering or Symptomatic Multiple Myeloma
Status:
Terminated
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
Multiple myeloma cells are dependent on calcium (Ca2+) for their function. Specifically, Ca2+
is required for the function of the endoplasmic reticulum in which proteins, including
immunoglobulins, are folded prior to their release from the cell. Multiple myeloma cells
secrete large concentrations of immunoglobulins continuously and as result depend on
mitochondria activity to replenish the Ca2+ levels in the endoplasmic reticulum as was shown
in vitro in our lab. Fenofibrate has been shown to inhibit mitochondrial function resulting
in inhibition of protein folding in the endoplasmic reticulum of multiple myeloma (MM) cells
that leads to the induction of a stress signal known as the unfolded protein response and
subsequently apoptosis. The effective anti-myeloma concentrations for fenofibrate are
attainable in the clinical setting as they are in the same range as the effective
concentrations for anti-hyperlipidemic effect. The investigators propose to evaluate
fenofibrate therapy in multiple myeloma patients.