Autophagy Induction After Bortezomib for Myeloma
This study is currently recruiting participants.
Verified February 2013 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Abramson Cancer Center of the University of Pennsylvania
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01594242
First received: April 19, 2012
Last updated: February 25, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Other: Bortezomib |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Primary Purpose: Treatment |
| Official Title: | A Phase 0 Study of Autophagy Induction After Bortezomib For Myeloma |
Resource links provided by NLM:
Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:
Primary Outcome Measures:
- Number of Adverse Events [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 15 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- - Histologically confirmed multiple myeloma (both newly diagnosed and relapsed patients are permitted)
- No prior therapy with bortezomib or any other proteasome inhibitor
- Planned therapy, as determined by the patFients 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 less than 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594242
Contacts
| Contact: Dan Vogl, MD | 855-216-0098 | PennCancerTrials@emergingmed.com |
Locations
| United States, Pennsylvania | |
| Abramson Cancer Center of the University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Amanda Gordon, RN 855-216-0098 PennCancerTrials@emergingmed.com | |
| Principal Investigator: Dan Vogl, MD | |
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
| Principal Investigator: | Dan Vogl, MD | Abramson Cancer Center of the University of Pennsylvania |
More Information
No publications provided
| Responsible Party: | Abramson Cancer Center of the University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01594242 History of Changes |
| Other Study ID Numbers: | UPCC 05411 |
| Study First Received: | April 19, 2012 |
| Last Updated: | February 25, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
|
multiple myeloma bortezomib proteasome inhibitor |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013