Autophagy Induction After Bortezomib for Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01594242
Recruitment Status : Active, not recruiting
First Posted : May 9, 2012
Last Update Posted : September 26, 2016
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Other: Bortezomib Early Phase 1

Detailed Description:


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.


  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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: A Phase 0 Study of Autophagy Induction After Bortezomib For Myeloma
Study Start Date : April 2012
Actual Primary Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Bortezomib
U.S. FDA Resources

Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01594242

United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Principal Investigator: Dan Vogl, MD Abramson Cancer Center of the University of Pennsylvania

Responsible Party: Abramson Cancer Center of the University of Pennsylvania Identifier: NCT01594242     History of Changes
Other Study ID Numbers: UPCC 05411
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
multiple myeloma
proteasome inhibitor

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents