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Autophagy Induction After Bortezomib for Myeloma

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ClinicalTrials.gov Identifier: NCT01594242
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : April 16, 2019
Sponsor:
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 Drug: Bortezomib Early Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: A Phase 0 Study of Autophagy Induction After Bortezomib For Myeloma
Actual Study Start Date : July 10, 2012
Actual Primary Completion Date : March 2, 2015
Actual Study Completion Date : March 2, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Bortezomib

Arm Intervention/treatment
Experimental: Autophagy Induction After Bortezomib

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.

Drug: Bortezomib



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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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 ClinicalTrials.gov identifier (NCT number): NCT01594242


Locations
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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
Investigators
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Principal Investigator: Dan Vogl, MD Abramson Cancer Center of the University of Pennsylvania
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01594242    
Other Study ID Numbers: UPCC 05411
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
multiple myeloma
bortezomib
proteasome inhibitor
Additional relevant MeSH terms:
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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