A Phase 0 Study of Autophagy Induction After Bortezomib For Myeloma
18 Years
N/A
Both
Multiple Myeloma
Trial Information
A Phase 0 Study of Autophagy Induction After Bortezomib For Myeloma
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
Inclusion Criteria:
- - Histologically confirmed multiple myeloma (both newly diagnosed and relapsed
patients are permitted)
- No prior therapy with bortezomib or any other proteasome inhibitor
- Planned therapy, as determined by the patFients 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
Exclusion Criteria:
- - Age less than 18 years (though the demographics of myeloma make it highly unlikely
that any children will meet inclusion criteria)
- 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment
Outcome Measure:
Number of Adverse Events
Safety Issue:
Yes
Principal Investigator
Dan Vogl, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Abramson Cancer Center of the University of Pennsylvania
Authority:
United States: Institutional Review Board
Study ID:
UPCC 05411
NCT ID:
NCT01594242
Start Date:
April 2012
Completion Date:
April 2013
Related Keywords:
- Multiple Myeloma
- multiple myeloma
- bortezomib
- proteasome inhibitor
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
