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Effect of Bortezomib (Velcade)-Based Therapy on Cellular Immunity and Response to DC/Myeloma Fusion Vaccines in Vitro


N/A
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

Effect of Bortezomib (Velcade)-Based Therapy on Cellular Immunity and Response to DC/Myeloma Fusion Vaccines in Vitro


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Effect of bortezomib on circulating dendritic cell and T cell populations

Outcome Description:

Whether treatment with bortezomib reverses measures of tumor mediated immune suppression proving an improved platform for tumor specific immunotherapy

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Jacalyn Rosenblatt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Institutional Review Board

Study ID:

10-272

NCT ID:

NCT01472627

Start Date:

October 2010

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • MM
  • Bortezomib
  • Velcade
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115