Back to resultsAutophagy Induction After Bortezomib for Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bortezomib
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring multiple myeloma, bortezomib, proteasome inhibitor
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.
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Autophagy Induction After Bortezomib
Arm Description
Subjects will undergo a baseline bone marrow aspirate and biopsy (under sedation if preferred by the subject) and have baseline blood samples (and urine samples if clinically indicated for measurement of their myeloma). The following week, subjects will undergo a second bone marrow aspirate and biopsy and have additional blood samples taken for research assays prior to starting therapy on treatment day 1 with bortezomib at the standard dose of 1.3 mg/m2. Subjects will receive a second dose of bortezomib on treatment day 4, followed by a third bone marrow aspirate and biopsy on treatment day 4 or 5, along with serial blood samples on treatment days 4 and 5. After completion of the week of study treatment, subjects may continue treatment with the bortezomib-containing regimen planned by their treating oncologist. Active study participation will end after the completion of the week of study treatment.
Outcomes
Primary Outcome Measures
Number of Adverse Events
Secondary Outcome Measures
Full Information
NCT ID
NCT01594242
First Posted
April 19, 2012
Last Updated
April 12, 2019
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01594242
Brief Title
Autophagy Induction After Bortezomib for Myeloma
Official Title
A Phase 0 Study of Autophagy Induction After Bortezomib For Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 10, 2012 (Actual)
Primary Completion Date
March 2, 2015 (Actual)
Study Completion Date
March 2, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
multiple myeloma, bortezomib, proteasome inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Patients who are planned to start a bortezomib-containing regimen (whether for newly diagnosed or relapsed myeloma) will begin with one week off therapy and then one week of single agent bortezomib to allow investigation of its effects on cellular metabolism. Patients may then go on to receive bortezomib in whatever combination is planned by their treating oncologist.
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Autophagy Induction After Bortezomib
Arm Type
Experimental
Arm Description
Subjects will undergo a baseline bone marrow aspirate and biopsy (under sedation if preferred by the subject) and have baseline blood samples (and urine samples if clinically indicated for measurement of their myeloma).
The following week, subjects will undergo a second bone marrow aspirate and biopsy and have additional blood samples taken for research assays prior to starting therapy on treatment day 1 with bortezomib at the standard dose of 1.3 mg/m2. Subjects will receive a second dose of bortezomib on treatment day 4, followed by a third bone marrow aspirate and biopsy on treatment day 4 or 5, along with serial blood samples on treatment days 4 and 5. After completion of the week of study treatment, subjects may continue treatment with the bortezomib-containing regimen planned by their treating oncologist. Active study participation will end after the completion of the week of study treatment.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Primary Outcome Measure Information:
Title
Number of Adverse Events
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Vogl, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Autophagy Induction After Bortezomib for Myeloma
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