NCT01594242

Autophagy Induction After Bortezomib for Myeloma

A Phase 0 Study of Autophagy Induction After Bortezomib For Myeloma

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Bortezomib

Timeline

• Start date: 2012-07-10
• Primary completion: 2015-03-02
• Completion: 2015-03-02
• First posted: 2012-05-09
• Last updated: 2019-04-16

Locations

1 site across 1 country: United States