Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatment bortezomib
Phase phase 0
Target proteasome
Sponsor Abramson Cancer Center of the University of Pennsylvania
Start date April 2012
End date June 2015
Trial size 11 participants
Trial identifier NCT01594242, UPCC 05411

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Primary purpose treatment

Primary Outcomes

Measure
Number of Adverse Events
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Phase 0 Study of Autophagy Induction After Bortezomib For Myeloma
Principal investigator Dan Vogl, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Abramson Cancer Center of the University of Pennsylvania.