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Effects of Bortezomib-Based Therapy on Cellular Immunity and Response to DC/Myeloma Fusion Vaccines in Vitro

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.
ClinicalTrials.gov Identifier: NCT01472627
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : January 11, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to better understand what effects Bortezomib, a drug used for multiple myeloma therapy, has on the immune system.

Condition or disease Intervention/treatment
Multiple Myeloma Procedure: Blood draws

Detailed Description:

Subjects on this study will be receiving treatment for multiple myeloma according to the standard of care with a regimen containing Bortezomib.

If a bone marrow sample is clinically indicated to guide treatment, an additional 1 tablespoon of the specimen will be obtained for further laboratory studies.

Approximately 3 tablespoons of blood will be taken for research purposes before therapy with Bortezomib starts. When subjects return for follow-up after cycle 1, 2, and 3 and additional 3 tablespoons of blood will be taken for research purposes.

Optional samples of blood may be taken at follow-up visits after cycles 4, 5 and 6 and 1, 3 and 6 months after completing therapy.

This study also includes a medical record review.


Study Design

Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Bortezomib (Velcade)-Based Therapy on Cellular Immunity and Response to DC/Myeloma Fusion Vaccines in Vitro
Study Start Date : October 2010
Primary Completion Date : January 2018
Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

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

Groups and Cohorts

Group/Cohort Intervention/treatment
Bortezomib treatment
Subjects receiving standard of care regimen including Bortezomib
Procedure: Blood draws
Blood draws


Outcome Measures

Primary Outcome Measures :
  1. Effect of bortezomib on circulating dendritic cell and T cell populations [ Time Frame: 2 years ]
    Whether treatment with bortezomib reverses measures of tumor mediated immune suppression proving an improved platform for tumor specific immunotherapy


Biospecimen Retention:   Samples Without DNA
Peripheral blood samples, bone marrow

Eligibility Criteria

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
Sampling Method:   Non-Probability Sample
Study Population
Receiving standard of care treatment with a regimen containing bortezomib at Beth Israel Medical Center or Dana-Farber Cancer Institute
Criteria

Inclusion Criteria:

  • Newly diagnosed multiple myeloma
  • Therapy with bortezomib alone or bortezomib/dexamethasone being initiated as the standard of care therapy for myeloma by their treating physician

Exclusion Criteria:

  • Hypersensitivity to bortezomib, boron or mannitol
  • Treatment with other investigational drugs within 28 days before enrollment
  • Diagnosed or treated for another malignancy within 6 months of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
  • Use of other myeloma directed therapy (except for dexamethasone) in combination with bortezomib
Contacts and Locations

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): NCT01472627


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Millennium Pharmaceuticals, Inc.
Investigators
Principal Investigator: Jacalyn Rosenblatt, MD Beth Israel Deaconess Medical Center
More Information

Responsible Party: Jacalyn Rosenblatt, MD, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01472627     History of Changes
Other Study ID Numbers: 10-272
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Keywords provided by Jacalyn Rosenblatt, MD, Beth Israel Deaconess Medical Center:
MM
Bortezomib
Velcade

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