Autophagy Induction After Bortezomib for Myeloma

Multiple Myeloma Clinical Trial

Official title:

A Phase 0 Study of Autophagy Induction After Bortezomib For Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594242
• Other study ID #: UPCC 05411
• Status: Completed
• Phase: Early Phase 1
• Start date: July 10, 2012
• Est. completion date: March 2, 2015

Study information

• Verified date: April 2019
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 2, 2015
• Est. primary completion date: March 2, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Bortezomib

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events		2 years