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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Jacalyn Rosenblatt, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
First received: August 25, 2011
Last updated: January 14, 2016
Last verified: January 2016
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 Intervention
Multiple Myeloma
Procedure: Blood draws

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Effect of bortezomib on circulating dendritic cell and T cell populations [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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

Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Bortezomib treatment
Subjects receiving standard of care regimen including Bortezomib
Procedure: Blood draws
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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
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: NCT01472627

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
Beth Israel Deaconess Medical Center
Principal Investigator: Jacalyn Rosenblatt, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Jacalyn Rosenblatt, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01472627     History of Changes
Other Study ID Numbers: 10-272 
Study First Received: August 25, 2011
Last Updated: January 14, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

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

ClinicalTrials.gov processed this record on May 26, 2016