Autophagy Induction After Bortezomib for Myeloma

• Status: Completed
• Trial end date: 2015-03-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Treatments: Bortezomib

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria

• Age <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.