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A Phase 0 Study of Autophagy Induction After Bortezomib For Myeloma

Phase 0
18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

A Phase 0 Study of Autophagy Induction After Bortezomib For Myeloma


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


1. To determine the optimal timing of autophagy assessments for patients receiving

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:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Outcome Measure:

Number of Adverse Events

Safety Issue:


Principal Investigator

Dan Vogl, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania


United States: Institutional Review Board

Study ID:

UPCC 05411



Start Date:

April 2012

Completion Date:

April 2013

Related Keywords:

  • Multiple Myeloma
  • multiple myeloma
  • bortezomib
  • proteasome inhibitor
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283