Multiple Myeloma Clinical Trial

Autophagy Induction After Bortezomib for Myeloma

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.

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Full 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

To determine the optimal timing of autophagy assessments for patients receiving bortezomib.
To explore whether high levels of autophagy are associated with resistance to bortezomib therapy.
To validate our primary assay by confirming baseline stability of the number of autophagic vesicles per cell
To compare results of autophagy measurements in peripheral blood mononuclear cells and bone marrow plasma cells

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Multiple Myeloma

Phase:

Early Phase 1

Estimated Enrollment:

11

Study ID:

NCT01594242

Recruitment Status:

Completed

Sponsor:

Abramson Cancer Center of the University of Pennsylvania

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There is 1 Location for this study

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Abramson Cancer Center of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Early Phase 1

Estimated Enrollment:

11

Study ID:

NCT01594242

Recruitment Status:

Completed

Sponsor:


Abramson Cancer Center of the University of Pennsylvania

How clear is this clinincal trial information?

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