Autophagy Induction After Bortezomib for Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
multiple myeloma, bortezomib, proteasome inhibitor
Study Type
Interventional
Study Phase
Phase 0
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment
Intervention
Name: Bortezomib
Type: Other
Overall Status
Recruiting
Summary
The purpose of this study is to better understand the effects of the chemotherapy medication bortezomib on cancer cells. The investigators are therefore taking blood and bone marrow samples from patients with myeloma who are receiving bortezomib to see if the investigators can detect autophagy in the myeloma cells from the bone marrow and in immune cells in the blood. Subjects are eligible if their doctor is planning to treat them with bortezomib for the first time for their myeloma.
Detailed Description
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Location
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Amanda Gordon, RN - 855-216-0098 - PennCancerTrials@emergingmed.com
Start Date
April 2012
Completion Date
April 2015
Sponsors
Abramson Cancer Center of the University of Pennsylvania
Source
Abramson Cancer Center of the University of Pennsylvania
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page