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Autophagy Induction After Bortezomib for Myeloma

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01594242
First received: April 19, 2012
Last updated: October 10, 2014
Last verified: October 2014
  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 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 10, 2014
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
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Bortezomib
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014