Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Abramson Cancer Center at Penn Medicine
PRIMARY OBJECTIVE:
The primary objective of this study is to determine whether administration of bortezomib leads to an increase in cellular autophagy, as determined by electron micrographs of peripheral blood lymphocytes and primary myeloma cells in patients receiving single-agent bortezomib.
SECONDARY OBJECTIVES
1. To determine the optimal timing of autophagy assessments for patients receiving bortezomib.
2. To explore whether high levels of autophagy are associated with resistance to bortezomib therapy.
3. To validate our primary assay by confirming baseline stability of the number of autophagic vesicles per cell
4. To compare results of autophagy measurements in peripheral blood mononuclear cells and bone marrow plasma cells
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed multiple myeloma (both newly diagnosed and relapsed patients are permitted)
No more than one line of prior therapy containing bortezomib. No prior therapy with any other proteasome inhibitor.
For subjects who received previous bortezomib, at least a partial response while on the bortezomib-containing therapy, without progression while on bortezomib-containing therapy or within 90 days of stopping bortezomib.
Planned therapy, as determined by the patient's treating physician, with a bortezomib-containing regimen
Medically suitable to undergo study procedures, including a one-week washout of prior therapy, one week of observation, and one week of single-agent bortezomib
Provision of written informed consent
Treatment with other anti-myeloma agents, including corticosteroids, thalidomide, or lenalidomide, within the 7 days prior to the study baseline bone marrow biopsy.
Inability to understand the informed consent document or unwillingness to consent.
Written informed consent must be obtained from all patients before study entry.
